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Pharmacy / Re: দীর্ঘদিন ধরে প্যারাসিটামল সেবন ভয়াবহ পরিণাম ডেকে আনতে পারে
« on: March 23, 2015, 10:15:34 PM »
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Pharmacy / রোগের নাম গুলেন ব্যারি সিনড্রোম
« on: March 23, 2015, 10:00:45 PM »
গুলেন ব্যারি সিনড্রোম বা সংক্ষেপে জিবিএস নামটি অনেকের কাছে অপরিচিত হলেও রোগটির প্রাদুর্ভাব বাংলাদেশে একেবারে কম নয়। যেকোনো বয়সের শিশু-কিশোর বা নারী-পুরুষের এ রোগ হতে পারে। এতে বিভিন্ন অঙ্গপ্রত্যঙ্গ থেকে শুরু করে সারা শরীরে দুর্বলতা দেখা দিতে পারে এবং একপর্যায়ে নড়াচড়ার সামর্থ্যও হারিয়ে যেতে পারে।
জিবিএসের মূল কারণ জীবাণু হলেও প্রকৃতপক্ষে জীবাণু-প্রতিরোধী ইমিউন সিস্টেমের অস্বাভাবিক আচরণের ফলে এই রোগের উৎপত্তি হয়। ‘ক্যাম্পাইলো ব্যাকটর জেজুনি’ জীবাণুতে আক্রান্ত ডায়রিয়া রোগী বা ইনফ্লুয়েঞ্জা ভাইরাসে আক্রান্ত সর্দি-জ্বরের রোগীরা পরবর্তী পর্যায়ে জিবিএসে আক্রান্ত হয়। কখনো কখনো ভ্যাকসিন দেওয়ার পরেও জিবিএস হতে পারে। ডায়রিয়া বা ইনফ্লুয়েঞ্জা জ্বরে আক্রান্ত হওয়ার প্রায় দুই সপ্তাহ পরে রোগী হঠাৎ করে প্রথমে দুই পায়ে দুর্বলতা বোধ করে, যা ধীরে ধীরে বাড়তে থাকে এবং উপরের দিকে ছড়িয়ে পড়তে থাকে। ক্রমে এই দুর্বলতা মেরুদণ্ড, দুই হাত, বুক ও মুখের মাংসপেশিতে ছড়িয়ে পড়ে। কখনো কখনো দুর্বলতা এত বেশি হয় যে রোগী হাত-পায়ের আঙুল একটুও নাড়াতে পারে না।
বুকের মাংসপেশির দুর্বলতার কারণে শ্বাসকষ্ট হলে রোগীকে আইসিইউ বা ‘নিবিড় পর্যবেক্ষণ ইউনিটে’ স্থানান্তর করতে হয়। নইলে রোগী মারাও যেতে পারে। তবে জিবিএস রোগীর স্নায়ুর সমস্যা ও পেশির দুর্বলতা থাকলেও সাধারণ অনুভূতি, স্মৃতিশক্তি, পায়খানা-প্রস্রাবের তেমন সমস্যা হয় না এবং রোগী কখনো অজ্ঞান হয়ে যায় না। রোগের ইতিহাস, উপসর্গ ও চিকিৎসকের পরামর্শ অনুযায়ী স্নায়ু পরীক্ষা বা মেরুদণ্ডের রস পরীক্ষা করে এই রোগটি নির্ণয় করা হয়।
জিবিএস রোগীকে হাসপাতালে ভর্তি করে চিকিৎসা দেওয়া উচিত। এই রোগের নির্দিষ্ট চিকিৎসা হলো প্লাজমাফেরোসিস বা শিরায় ইমিউনোগ্লোবিউলিন ইনজেকশন। উপসর্গ দেখা দেওয়ার দুই সপ্তাহের মধ্যে এ চিকিৎসা দিতে হয়। নয়তো এরপর ইমিউনোগ্লোবিউলিনের কার্যকারিতা থাকে না। নিয়মিত হাত-পায়ের ব্যায়াম করা, পুষ্টিকর খাবার গ্রহণ ও পরিষ্কার-পরিচ্ছন্নতা বজায় রাখলে রোগী দ্রুত সেরে উঠতে পারে। কোনো কোনো রোগীর পুরোপুরি আরোগ্য পেতে প্রায় এক বছর লেগে যেতে পারে। জিবিএসের ক্ষেত্রে সাধারণত প্রায় ৮০ শতাংশ রোগী সম্পূর্ণ সেরে ওঠে, ৫ থেকে ১০ শতাংশ রোগীর কিছু না কিছু শারীরিক দুর্বলতা স্থায়ীভাবে থেকে যায় এবং প্রায় ৫ থেকে ৬ শতাংশ রোগী মারা যায়।
ক্লিনিক্যাল নিউরোলজি বিভাগ, ন্যাশনাল ইনস্টিটিউট অব নিউরোসায়েন্সেস
জিবিএসের মূল কারণ জীবাণু হলেও প্রকৃতপক্ষে জীবাণু-প্রতিরোধী ইমিউন সিস্টেমের অস্বাভাবিক আচরণের ফলে এই রোগের উৎপত্তি হয়। ‘ক্যাম্পাইলো ব্যাকটর জেজুনি’ জীবাণুতে আক্রান্ত ডায়রিয়া রোগী বা ইনফ্লুয়েঞ্জা ভাইরাসে আক্রান্ত সর্দি-জ্বরের রোগীরা পরবর্তী পর্যায়ে জিবিএসে আক্রান্ত হয়। কখনো কখনো ভ্যাকসিন দেওয়ার পরেও জিবিএস হতে পারে। ডায়রিয়া বা ইনফ্লুয়েঞ্জা জ্বরে আক্রান্ত হওয়ার প্রায় দুই সপ্তাহ পরে রোগী হঠাৎ করে প্রথমে দুই পায়ে দুর্বলতা বোধ করে, যা ধীরে ধীরে বাড়তে থাকে এবং উপরের দিকে ছড়িয়ে পড়তে থাকে। ক্রমে এই দুর্বলতা মেরুদণ্ড, দুই হাত, বুক ও মুখের মাংসপেশিতে ছড়িয়ে পড়ে। কখনো কখনো দুর্বলতা এত বেশি হয় যে রোগী হাত-পায়ের আঙুল একটুও নাড়াতে পারে না।
বুকের মাংসপেশির দুর্বলতার কারণে শ্বাসকষ্ট হলে রোগীকে আইসিইউ বা ‘নিবিড় পর্যবেক্ষণ ইউনিটে’ স্থানান্তর করতে হয়। নইলে রোগী মারাও যেতে পারে। তবে জিবিএস রোগীর স্নায়ুর সমস্যা ও পেশির দুর্বলতা থাকলেও সাধারণ অনুভূতি, স্মৃতিশক্তি, পায়খানা-প্রস্রাবের তেমন সমস্যা হয় না এবং রোগী কখনো অজ্ঞান হয়ে যায় না। রোগের ইতিহাস, উপসর্গ ও চিকিৎসকের পরামর্শ অনুযায়ী স্নায়ু পরীক্ষা বা মেরুদণ্ডের রস পরীক্ষা করে এই রোগটি নির্ণয় করা হয়।
জিবিএস রোগীকে হাসপাতালে ভর্তি করে চিকিৎসা দেওয়া উচিত। এই রোগের নির্দিষ্ট চিকিৎসা হলো প্লাজমাফেরোসিস বা শিরায় ইমিউনোগ্লোবিউলিন ইনজেকশন। উপসর্গ দেখা দেওয়ার দুই সপ্তাহের মধ্যে এ চিকিৎসা দিতে হয়। নয়তো এরপর ইমিউনোগ্লোবিউলিনের কার্যকারিতা থাকে না। নিয়মিত হাত-পায়ের ব্যায়াম করা, পুষ্টিকর খাবার গ্রহণ ও পরিষ্কার-পরিচ্ছন্নতা বজায় রাখলে রোগী দ্রুত সেরে উঠতে পারে। কোনো কোনো রোগীর পুরোপুরি আরোগ্য পেতে প্রায় এক বছর লেগে যেতে পারে। জিবিএসের ক্ষেত্রে সাধারণত প্রায় ৮০ শতাংশ রোগী সম্পূর্ণ সেরে ওঠে, ৫ থেকে ১০ শতাংশ রোগীর কিছু না কিছু শারীরিক দুর্বলতা স্থায়ীভাবে থেকে যায় এবং প্রায় ৫ থেকে ৬ শতাংশ রোগী মারা যায়।
ক্লিনিক্যাল নিউরোলজি বিভাগ, ন্যাশনাল ইনস্টিটিউট অব নিউরোসায়েন্সেস
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Pharmacy / ঘুমের অভাবে রক্তচাপ বৃদ্ধি
« on: March 23, 2015, 09:59:22 PM »
ঘুম অপর্যাপ্ত হলে রাতে রক্তচাপ বৃদ্ধি পায়। কাজেই দীর্ঘদিন ধরে যাঁরা অনিদ্রায় ভুগছেন, তাঁদের হৃদ্রোগে আক্রান্ত হওয়ার ঝুঁকি বেশি। যুক্তরাষ্ট্রের মায়ো ক্লিনিকের একদল গবেষক এ কথা জানিয়েছেন। আমেরিকান কলেজ অব কার্ডিওলজির ৬৪তম বার্ষিক বিজ্ঞান অধিবেশনে গত রোববার ওই গবেষণা প্রতিবেদন উপস্থাপন করা হয়। গবেষক দলটির প্রধান নাইমা কোভাসিন বলেন, তাঁরা এই প্রথম অনিদ্রা ও নৈশকালীন রক্তচাপ বৃদ্ধির মধ্যে সরাসরি সম্পর্কের প্রমাণ পেয়েছেন। রাতে উচ্চরক্তচাপ থাকলে হৃদ্রোগের ঝুঁকি অনেকটাই বেড়ে যায়। গবেষণায় দেখা যায়, রাতের ঘুম স্বাভাবিকের তুলনায় কম হলে রাতে হৃৎস্পন্দনের গতিও বৃদ্ধি পায়। আইএএনএস।
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Pharmacy / এশিয়ার নীরব প্রাণঘাতক ‘সুপারি’
« on: March 23, 2015, 09:56:54 PM »
বিশ্বের মোট জনগোষ্ঠীর প্রায় এক-দশমাংশ এটি ব্যবহার করে। চাঙা করার ক্ষেত্রে ছয় কাপ কফির সমান ফল দেয় এটি। কোথাও কোথাও একে দেখা হয় ভালোবাসা ও বিয়ের প্রতীক হিসেবে। আবার কখনো কখনো এটি বদহজম ও বন্ধ্যাত্বের মতো সমস্যার ওষুধ হিসেবেও ব্যবহৃত হয়। এত গুণসম্পন্ন বস্তুটির নাম ‘সুপারি’। তবে হালে ক্যানসারের সঙ্গে এর সংশ্লিষ্টতার কারণে এটি ‘নীরব মরণ ঘাতক’ হিসেবে পরিচিতি পাচ্ছে।
বিবিসি অনলাইনের খবরে বলা হয়েছে, সুপারির জন্য এশিয়া প্রসিদ্ধ। উদ্দীপক উপাদানের কারণে অনেকেই নিয়মিত সুপারি চিবিয়ে থাকেন। বিশেষ করে গাড়ি চালানো, মাছ ধরা কিংবা নির্মাণকাজের মতো বিষয়ে যাঁরা যুক্ত থাকেন, তাঁরা দীর্ঘ সময় জেগে থাকার জন্য এটি ব্যবহার করেন। সুপারিকে তাই মানসিক বিভ্রম সৃষ্টিকারী মাদক হিসেবে বিবেচনা করা হয়।
বাংলাদেশেও পানের সঙ্গে সুপারি খাওয়া হয়। বহু মানুষ এটিতে অভ্যস্ত। তবে এভাবে সুপারিতে আসক্তির বড় সমস্যা হলো, সুপারিতে অভ্যস্ত মানুষের মুখের ক্যানসারের ঝুঁকি অনেক বেশি থাকে। এর দীর্ঘমেয়াদি প্রভাব এতটাই যে, প্রথমবার সুপারি খাওয়ার কয়েক দশক পরও এর প্রভাবে কারও মুখে ক্যানসার হতে পারে।
এশিয়ার যেসব দেশে সুপারি অনেক বেশি জনপ্রিয় তাইওয়ান সেগুলোর একটি। সুপারি ‘তাইওয়ানের চুইং গাম’ হিসেবে পরিচিত। সুযোগ পেলেই এখানকার বাসিন্দারা চুইং গামের মতো সুপারি চিবোতে পছন্দ করেন। এখনো খালি সুপারি চিবোন তাঁরা; আবার কখনো পানপাতা, চুন, এলাচি বা দারুচিনির মতো মসলার সঙ্গে মিশিয়ে সুপারি খেয়ে থাকেন তাঁরা। বিষয়টি এখানকার সংস্কৃতির অংশ হয়ে পড়েছে। তবে ক্যানসারের মতো মরণব্যাধিতে আক্রান্ত হয়ে এর খেসারত দিতে হচ্ছে ব্যবহারকারীদের।
আন্তর্জাতিক ক্যানসার গবেষণা সংস্থা এসব উপাদানের মধ্যে চুনকে ক্যানসার সৃষ্টিকারী উপাদান হিসেবে তালিকাভুক্ত করেছে। পান-সুপারির সঙ্গে চুন ব্যবহারের ফলে মুখের ভেতর ক্ষত তৈরি হতে পারে। সে ক্ষেত্রে ক্যানসার সৃষ্টিকারী উপাদান ক্ষতের মাধ্যমে শরীরে প্রবেশ করতে পারে।
তাইওয়ানের ন্যাশনাল ইউনিভার্সিটি হসপিটালের মুখের ক্যানসার বিশেষজ্ঞ হান লিয়াং-জুন বলেন, অর্ধেক মানুষ এখনো জানেই না যে সুপারি মুখের ক্যানসারের অন্যতম কারণ। সুপারির কারণে মুখের ক্যানসারে আক্রান্ত হয়ে মৃত্যুহারের দিক থেকে শীর্ষ তিনটি দেশের একটি তাইওয়ান।
তাইওয়ানের সরকার মানুষের জীবন বাঁচাতে বহু বছরের পুরোনো এই অভ্যাসটি কমিয়ে আনতে নানা ধরনের উদ্যোগ নিয়েছে। এসব উদ্যোগের ফলও পেতে শুরু করেছে দেশটি। সুপারি ব্যবহারকারীর সংখ্যা খানিকটা কমেছে। সুপারির কুফল সম্পর্কে ব্যবহারকারীদের সচেতন করতে ভারত ও থাইল্যান্ডও প্রচারকাজ শুরু করেছে।
বিবিসি অনলাইনের খবরে বলা হয়েছে, সুপারির জন্য এশিয়া প্রসিদ্ধ। উদ্দীপক উপাদানের কারণে অনেকেই নিয়মিত সুপারি চিবিয়ে থাকেন। বিশেষ করে গাড়ি চালানো, মাছ ধরা কিংবা নির্মাণকাজের মতো বিষয়ে যাঁরা যুক্ত থাকেন, তাঁরা দীর্ঘ সময় জেগে থাকার জন্য এটি ব্যবহার করেন। সুপারিকে তাই মানসিক বিভ্রম সৃষ্টিকারী মাদক হিসেবে বিবেচনা করা হয়।
বাংলাদেশেও পানের সঙ্গে সুপারি খাওয়া হয়। বহু মানুষ এটিতে অভ্যস্ত। তবে এভাবে সুপারিতে আসক্তির বড় সমস্যা হলো, সুপারিতে অভ্যস্ত মানুষের মুখের ক্যানসারের ঝুঁকি অনেক বেশি থাকে। এর দীর্ঘমেয়াদি প্রভাব এতটাই যে, প্রথমবার সুপারি খাওয়ার কয়েক দশক পরও এর প্রভাবে কারও মুখে ক্যানসার হতে পারে।
এশিয়ার যেসব দেশে সুপারি অনেক বেশি জনপ্রিয় তাইওয়ান সেগুলোর একটি। সুপারি ‘তাইওয়ানের চুইং গাম’ হিসেবে পরিচিত। সুযোগ পেলেই এখানকার বাসিন্দারা চুইং গামের মতো সুপারি চিবোতে পছন্দ করেন। এখনো খালি সুপারি চিবোন তাঁরা; আবার কখনো পানপাতা, চুন, এলাচি বা দারুচিনির মতো মসলার সঙ্গে মিশিয়ে সুপারি খেয়ে থাকেন তাঁরা। বিষয়টি এখানকার সংস্কৃতির অংশ হয়ে পড়েছে। তবে ক্যানসারের মতো মরণব্যাধিতে আক্রান্ত হয়ে এর খেসারত দিতে হচ্ছে ব্যবহারকারীদের।
আন্তর্জাতিক ক্যানসার গবেষণা সংস্থা এসব উপাদানের মধ্যে চুনকে ক্যানসার সৃষ্টিকারী উপাদান হিসেবে তালিকাভুক্ত করেছে। পান-সুপারির সঙ্গে চুন ব্যবহারের ফলে মুখের ভেতর ক্ষত তৈরি হতে পারে। সে ক্ষেত্রে ক্যানসার সৃষ্টিকারী উপাদান ক্ষতের মাধ্যমে শরীরে প্রবেশ করতে পারে।
তাইওয়ানের ন্যাশনাল ইউনিভার্সিটি হসপিটালের মুখের ক্যানসার বিশেষজ্ঞ হান লিয়াং-জুন বলেন, অর্ধেক মানুষ এখনো জানেই না যে সুপারি মুখের ক্যানসারের অন্যতম কারণ। সুপারির কারণে মুখের ক্যানসারে আক্রান্ত হয়ে মৃত্যুহারের দিক থেকে শীর্ষ তিনটি দেশের একটি তাইওয়ান।
তাইওয়ানের সরকার মানুষের জীবন বাঁচাতে বহু বছরের পুরোনো এই অভ্যাসটি কমিয়ে আনতে নানা ধরনের উদ্যোগ নিয়েছে। এসব উদ্যোগের ফলও পেতে শুরু করেছে দেশটি। সুপারি ব্যবহারকারীর সংখ্যা খানিকটা কমেছে। সুপারির কুফল সম্পর্কে ব্যবহারকারীদের সচেতন করতে ভারত ও থাইল্যান্ডও প্রচারকাজ শুরু করেছে।
5
Pharmacy / FDA Approves Fast-Acting Ebola Test
« on: March 15, 2015, 04:55:20 PM »
The U.S. Food and Drug Administration has approved Swiss drug maker Roche's fast-acting Ebola test for emergency use. The test - which checks for genetic traces of the often deadly virus - offers results in about three hours, compared to many tests on the market that can take a day to produce results, according to news reports.
It's hoped that the test -- called LightMix Ebola Zaire rRT-PCR -- can be used in the field to identify people infected with the strain of Ebola that has been causing havoc in West Africa since the spring. The test is still not approved for general use, the FDA said.
By diagnosing Ebola early, the goal is to offer quicker treatment of patients who show signs of the disease.
However, the Washington Post reported Monday that the test probably won't have a significant impact on Ebola diagnoses -- at least initially. The reason: many patients in West Africa live far from labs equipped with expensive testing techniques needed to interpret the results.
West Africa's Ebola outbreak has led to more than 12,400 confirmed cases and nearly 7,600 deaths in Guinea, Liberia and Sierra Leone.
It's hoped that the test -- called LightMix Ebola Zaire rRT-PCR -- can be used in the field to identify people infected with the strain of Ebola that has been causing havoc in West Africa since the spring. The test is still not approved for general use, the FDA said.
By diagnosing Ebola early, the goal is to offer quicker treatment of patients who show signs of the disease.
However, the Washington Post reported Monday that the test probably won't have a significant impact on Ebola diagnoses -- at least initially. The reason: many patients in West Africa live far from labs equipped with expensive testing techniques needed to interpret the results.
West Africa's Ebola outbreak has led to more than 12,400 confirmed cases and nearly 7,600 deaths in Guinea, Liberia and Sierra Leone.
6
Pharmacy / FDA Permits Mobile Medical Apps for Continuous Glucose monitoring
« on: March 15, 2015, 04:53:31 PM »
The U.S. Food and Drug Administration today allowed marketing of the first set of mobile medical apps that allow people with diabetes to automatically and securely share data from a continuous glucose monitor (CGM) with other people in real-time using an Apple mobile device such as an iPhone.
The Dexcom Share Direct Secondary Displays system’s data-sharing capability allows caregivers to a person with diabetes to monitor that individual’s blood sugar levels remotely through a legally marketed device that is available on mobile devices. Devices like the Dexcom Share were previously available through open source efforts, but were not in compliance with regulatory requirements. The Dexcom Share system is the first of its kind to offer a legally marketed solution for real-time remote monitoring of a patient’s CGM data.
“This innovative technology has been eagerly awaited by the diabetes community, especially caregivers of children with diabetes who want to monitor their glucose levels remotely,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Today’s marketing permission paves the way for similar technologies to be marketed in the United States.”
A CGM is a device that includes a small, wire-like sensor inserted just under the skin that provides a steady stream of information about glucose levels in the fluid around the cells (interstitial fluid). CGMs are worn externally and continuously display an estimate of blood glucose levels, and the direction and rate of change of these estimates. When used along with a blood glucose meter, CGM information can help people with diabetes detect when blood glucose values are approaching dangerously high and dangerously low levels.
The Dexcom Share system displays data from the G4 Platinum CGM System using two apps: one installed on the patient’s mobile device and one installed on the mobile device of another person. Using Dexcom Share’s mobile medical app, the user can designate people (“followers”) with whom to share their CGM data. The app receives real-time CGM data directly from the G4 Platinum System CGM receiver and transmits it to a Web-based storage location. The app of the “follower” can then download the CGM data and display it in real-time.
The FDA reviewed data for the Dexcom Share system through the de novo classification process, a regulatory pathway for low- to moderate-risk medical devices that are novel and not substantially equivalent to any legally marketed device. Data provided by the device maker showed the device functions as intended and transmits data accurately and securely.
Because the device is low to moderate risk, the FDA has classified the device as class II exempt from premarket submissions. In the future, manufacturers wishing to market devices like the Dexcom Share system will not need premarket clearance by the FDA prior to marketing, but they will still need to register and list their device with the agency, as well as follow other applicable laws and regulations.
“Exempting devices from premarket review is part of the FDA’s effort to ensure these products provide accurate and reliable results while still encouraging the development of devices that meet the needs of people living with diabetes and their caregivers,” said Gutierrez.
The Dexcom Share system does not replace real-time continuous glucose monitoring or standard home blood glucose monitoring. It is also not intended to be used by the patient in place of a primary display device. Additionally, CGM values alone are not approved to determine dosing of diabetes medications. CGMs must be calibrated by blood glucose meters, and treatment decisions, such as insulin dosing, should be based on readings from a blood glucose meter.
Diabetes is a serious, chronic metabolic condition where the body is unable to convert glucose into the energy needed to carry out daily activities. An estimated 25.8 million people in the U.S. – about 215,000 of them under age 20 – have diabetes. If left untreated, high blood glucose levels (hyperglycemia) can lead to serious long-term problems such as stroke, heart disease, and damage to the eyes, kidneys and nerves.
The Dexcom Share system is manufactured by Dexcom, Inc., located in San Diego, California.
Source: FDA
The Dexcom Share Direct Secondary Displays system’s data-sharing capability allows caregivers to a person with diabetes to monitor that individual’s blood sugar levels remotely through a legally marketed device that is available on mobile devices. Devices like the Dexcom Share were previously available through open source efforts, but were not in compliance with regulatory requirements. The Dexcom Share system is the first of its kind to offer a legally marketed solution for real-time remote monitoring of a patient’s CGM data.
“This innovative technology has been eagerly awaited by the diabetes community, especially caregivers of children with diabetes who want to monitor their glucose levels remotely,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Today’s marketing permission paves the way for similar technologies to be marketed in the United States.”
A CGM is a device that includes a small, wire-like sensor inserted just under the skin that provides a steady stream of information about glucose levels in the fluid around the cells (interstitial fluid). CGMs are worn externally and continuously display an estimate of blood glucose levels, and the direction and rate of change of these estimates. When used along with a blood glucose meter, CGM information can help people with diabetes detect when blood glucose values are approaching dangerously high and dangerously low levels.
The Dexcom Share system displays data from the G4 Platinum CGM System using two apps: one installed on the patient’s mobile device and one installed on the mobile device of another person. Using Dexcom Share’s mobile medical app, the user can designate people (“followers”) with whom to share their CGM data. The app receives real-time CGM data directly from the G4 Platinum System CGM receiver and transmits it to a Web-based storage location. The app of the “follower” can then download the CGM data and display it in real-time.
The FDA reviewed data for the Dexcom Share system through the de novo classification process, a regulatory pathway for low- to moderate-risk medical devices that are novel and not substantially equivalent to any legally marketed device. Data provided by the device maker showed the device functions as intended and transmits data accurately and securely.
Because the device is low to moderate risk, the FDA has classified the device as class II exempt from premarket submissions. In the future, manufacturers wishing to market devices like the Dexcom Share system will not need premarket clearance by the FDA prior to marketing, but they will still need to register and list their device with the agency, as well as follow other applicable laws and regulations.
“Exempting devices from premarket review is part of the FDA’s effort to ensure these products provide accurate and reliable results while still encouraging the development of devices that meet the needs of people living with diabetes and their caregivers,” said Gutierrez.
The Dexcom Share system does not replace real-time continuous glucose monitoring or standard home blood glucose monitoring. It is also not intended to be used by the patient in place of a primary display device. Additionally, CGM values alone are not approved to determine dosing of diabetes medications. CGMs must be calibrated by blood glucose meters, and treatment decisions, such as insulin dosing, should be based on readings from a blood glucose meter.
Diabetes is a serious, chronic metabolic condition where the body is unable to convert glucose into the energy needed to carry out daily activities. An estimated 25.8 million people in the U.S. – about 215,000 of them under age 20 – have diabetes. If left untreated, high blood glucose levels (hyperglycemia) can lead to serious long-term problems such as stroke, heart disease, and damage to the eyes, kidneys and nerves.
The Dexcom Share system is manufactured by Dexcom, Inc., located in San Diego, California.
Source: FDA
7
Pharmacy / Teva Receives FDA Approval for First Generic Nexium Delayed-Release Capsules
« on: March 15, 2015, 04:51:58 PM »
The U.S. Food and Drug Administration has approved the first generic version of Nexium (esomeprazole magnesium delayed-release capsules) to treat gastroesophageal reflux disease (GERD) in adults and children ages 1 and older. Esomeprazole is a proton pump inhibitor that reduces the amount of acid in the stomach.
Ivax Pharmaceuticals, Inc., a subsidiary of Teva Pharmaceuticals USA, has gained approval to market esomeprazole in 20 and 40 milligram capsules.
“Health care professionals and consumers can be assured that these FDA-approved generic drugs have met our rigorous standards,” said Kathleen Uhl, M.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “It is important for patients to have access to treatment options for chronic conditions.”
Esomeprazole capsules are also approved to reduce the risk of gastric ulcers associated with use of nonsteroidal anti-inflammatory drugs (NSAIDs), treat the stomach infection Helicobacter pylori along with certain antibiotics, and to treat conditions where the stomach makes too much acid, including Zollinger-Ellison syndrome.
Gastroesophageal reflux (GER) happens when stomach contents come back up into the esophagus. Stomach acid that touches the lining of the esophagus can cause acid indigestion (also called acid reflux or heartburn). GERD is a more serious, long-lasting (chronic) form of GER. GER that occurs more than twice a week for a few weeks could be GERD, which over time can lead to more serious health problems, such as inflammation of the esophagus (esophagitis) and respiratory problems.
Generic esomeprazole capsules will be dispensed with a patient Medication Guide that provides important information about the medication’s use and risks. The most serious risks are stomach problems, including severe diarrhea, and a warning that people who take multiple daily doses of PPIs for a long period of time may have an increased risk of bone fractures.
The most common side effects reported by those taking Nexium in clinical trials include headache, diarrhea, nausea, flatulence, abdominal pain, sleepiness, constipation, and dry mouth.
Generic prescription drugs approved by the FDA have the same high quality and strength as brand-name drugs. Generic prescription drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.
Ivax Pharmaceuticals, Inc., a subsidiary of Teva Pharmaceuticals USA, has gained approval to market esomeprazole in 20 and 40 milligram capsules.
“Health care professionals and consumers can be assured that these FDA-approved generic drugs have met our rigorous standards,” said Kathleen Uhl, M.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “It is important for patients to have access to treatment options for chronic conditions.”
Esomeprazole capsules are also approved to reduce the risk of gastric ulcers associated with use of nonsteroidal anti-inflammatory drugs (NSAIDs), treat the stomach infection Helicobacter pylori along with certain antibiotics, and to treat conditions where the stomach makes too much acid, including Zollinger-Ellison syndrome.
Gastroesophageal reflux (GER) happens when stomach contents come back up into the esophagus. Stomach acid that touches the lining of the esophagus can cause acid indigestion (also called acid reflux or heartburn). GERD is a more serious, long-lasting (chronic) form of GER. GER that occurs more than twice a week for a few weeks could be GERD, which over time can lead to more serious health problems, such as inflammation of the esophagus (esophagitis) and respiratory problems.
Generic esomeprazole capsules will be dispensed with a patient Medication Guide that provides important information about the medication’s use and risks. The most serious risks are stomach problems, including severe diarrhea, and a warning that people who take multiple daily doses of PPIs for a long period of time may have an increased risk of bone fractures.
The most common side effects reported by those taking Nexium in clinical trials include headache, diarrhea, nausea, flatulence, abdominal pain, sleepiness, constipation, and dry mouth.
Generic prescription drugs approved by the FDA have the same high quality and strength as brand-name drugs. Generic prescription drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.
8
Pharmacy / Re: কচু শাকের পুষ্টিগুণ
« on: March 15, 2015, 04:32:51 PM »
Nice articles. Provides us much information about this common vegetables
9
Pharmacy / FDA Clears System to Reduce Stroke Risk During Stent and Angioplasty Procedures
« on: March 15, 2015, 04:31:18 PM »
The U.S. Food and Drug Administration today cleared for marketing the ENROUTE Transcarotid Neuroprotection System (ENROUTE TNS), for use during a minimally invasive procedure to restore normal blood flow to narrowed carotid arteries. It is the first device designed to access the carotid arteries through an incision in the neck, instead of the groin, and uses a blood flow reversal system to capture pieces of the blockage dislodged during the procedure.
The carotid arteries are two large blood vessels on either side of the neck that supply oxygenated blood to the brain. Cholesterol or fatty substances can narrow one or both of the carotid arteries, causing carotid artery disease. If a piece of plaque breaks off, it can travel to arteries in the brain and cut off blood flow, resulting in a stroke. According to the National Heart Lung and Blood Institute, more than half of the strokes occurring in the United States each year are caused by carotid artery disease. A person with the disease may not experience any signs or symptoms until a stroke occurs.
A severe narrowing or blockage of the carotid artery may require a physician to perform a minimally-invasive balloon angioplasty procedure in which a balloon on a long flexible tube called a catheter is threaded through a patient’s vasculature from the groin to the site of the blockage, inflated to open the artery and then a small mesh tube called a stent is placed at the site to keep the artery open.
The ENROUTE TNS allows physicians to insert a catheter into the artery in the neck above the narrowed or blocked section of the artery rather than having to enter through the groin. During the stenting procedure, physicians typically use a filter or additional balloon to capture and remove small pieces of debris that might be dislodged and potentially travel to the brain.
The ENROUTE TNS captures debris by temporarily shunting blood flowing through the narrowed section of the artery away from the brain and into a filtering system outside the body. Blood is then returned to the body though a vein in the leg. Because the carotid artery branches into many interconnected smaller arteries, the brain still receives oxygenated blood during the procedure.
“Until today’s clearance, the only FDA-cleared systems to capture and remove debris and prevent them from reaching the brain during carotid angioplasty and stenting procedures required entry into the body through the femoral artery using an incision in the groin,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation at the FDA’s Center for Device and Radiological Health. “The ENROUTE TNS provides a minimally-invasive treatment for certain patients whose tortuous (twisted) or diseased vasculature does not permit access via the groin for treating their narrowed carotid arteries.”
The FDA reviewed the data for the ENROUTE TNS through a 510(k) submission, a regulatory pathway for low-to-moderate risk medical devices that are substantially equivalent to a legally marketed predicate device that is not subject to premarket approval. In this case, the FDA found the ENROUTE TNS to be substantially equivalent to a flow reversal system currently on the market that uses similar technology and has the same intended use but is designed to be introduced into the patient through the blood vessels in the groin.
Data supporting the FDA’s clearance included the results from a clinical trial sponsored by the manufacturer. The trial showed that the rate of stroke, heart attack, and death among the ENROUTE TNS patients was 3.5 percent, significantly lower than the study performance goal of 11 percent. At least one serious adverse event occurred in 14.2 percent of patients, including excessive bleeding or injury at the device access site, low blood pressure due to the device or procedure, and blood clot formation within the placed stent. These events are consistent with the type and rate of serious adverse events associated with other carotid artery procedures.
The ENROUTE TNS is manufactured by Silk Road Medical of Sunnyvale, California.
The carotid arteries are two large blood vessels on either side of the neck that supply oxygenated blood to the brain. Cholesterol or fatty substances can narrow one or both of the carotid arteries, causing carotid artery disease. If a piece of plaque breaks off, it can travel to arteries in the brain and cut off blood flow, resulting in a stroke. According to the National Heart Lung and Blood Institute, more than half of the strokes occurring in the United States each year are caused by carotid artery disease. A person with the disease may not experience any signs or symptoms until a stroke occurs.
A severe narrowing or blockage of the carotid artery may require a physician to perform a minimally-invasive balloon angioplasty procedure in which a balloon on a long flexible tube called a catheter is threaded through a patient’s vasculature from the groin to the site of the blockage, inflated to open the artery and then a small mesh tube called a stent is placed at the site to keep the artery open.
The ENROUTE TNS allows physicians to insert a catheter into the artery in the neck above the narrowed or blocked section of the artery rather than having to enter through the groin. During the stenting procedure, physicians typically use a filter or additional balloon to capture and remove small pieces of debris that might be dislodged and potentially travel to the brain.
The ENROUTE TNS captures debris by temporarily shunting blood flowing through the narrowed section of the artery away from the brain and into a filtering system outside the body. Blood is then returned to the body though a vein in the leg. Because the carotid artery branches into many interconnected smaller arteries, the brain still receives oxygenated blood during the procedure.
“Until today’s clearance, the only FDA-cleared systems to capture and remove debris and prevent them from reaching the brain during carotid angioplasty and stenting procedures required entry into the body through the femoral artery using an incision in the groin,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation at the FDA’s Center for Device and Radiological Health. “The ENROUTE TNS provides a minimally-invasive treatment for certain patients whose tortuous (twisted) or diseased vasculature does not permit access via the groin for treating their narrowed carotid arteries.”
The FDA reviewed the data for the ENROUTE TNS through a 510(k) submission, a regulatory pathway for low-to-moderate risk medical devices that are substantially equivalent to a legally marketed predicate device that is not subject to premarket approval. In this case, the FDA found the ENROUTE TNS to be substantially equivalent to a flow reversal system currently on the market that uses similar technology and has the same intended use but is designed to be introduced into the patient through the blood vessels in the groin.
Data supporting the FDA’s clearance included the results from a clinical trial sponsored by the manufacturer. The trial showed that the rate of stroke, heart attack, and death among the ENROUTE TNS patients was 3.5 percent, significantly lower than the study performance goal of 11 percent. At least one serious adverse event occurred in 14.2 percent of patients, including excessive bleeding or injury at the device access site, low blood pressure due to the device or procedure, and blood clot formation within the placed stent. These events are consistent with the type and rate of serious adverse events associated with other carotid artery procedures.
The ENROUTE TNS is manufactured by Silk Road Medical of Sunnyvale, California.
10
Pharmacy / FDA issues new draft documents related to compounding of human drugs
« on: March 15, 2015, 04:29:51 PM »
the U.S. Food and Drug Administration issued five draft documents related to drug compounding and repackaging that will help entities comply with important public health provisions. The draft documents are applicable to pharmacies, federal facilities, outsourcing facilities and physicians.
The new category of outsourcing facilities was created under the Drug Quality and Security Act (DQSA), enacted by Congress in November 2013 in response to a deadly fungal meningitis outbreak that was linked to contaminated sterile compounded drug products. Drugs compounded in an outsourcing facility that meet certain conditions may be entitled to exemptions from certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including the new drug approval requirements and the requirement to label drug products with adequate directions for use. Outsourcing facilities are subject to current good manufacturing practice requirements and inspections by the FDA according to a risk-based schedule.
Drugs produced by compounders that are not registered as outsourcing facilities must meet certain other conditions described in the FD&C Act, or they will be subject to all of the requirements applicable to drugs produced by conventional drug manufacturers.
“The draft guidance documents provide information to pharmacies, outsourcing facilities, health care entities, and others about these FDA-proposed policies, which are critical to protecting the public health,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
The documents are:
Draft Guidance: For Entities Considering Whether to Register As Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act
The draft guidance provides an entity considering whether to register with the FDA as an outsourcing facility under the law with information about the regulatory impact of registering. For example, it explains that a facility engaged in only certain activities, including repackaging human drugs and compounding non-sterile drugs, should not register as an outsourcing facility because its drug products will not qualify for the exemptions provided in section 503B, including the exemption from the new drug approval requirements.
Draft Guidance for Industry: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities
The draft guidance describes the conditions under which the FDA does not intend to take action for certain violations of the law when state-licensed pharmacies, federal facilities or outsourcing facilities repackage certain drug products. Repackaging generally involves taking a finished drug product from the container in which it was distributed by the original manufacturer and placing it into a different container. Repackaged drug products are generally not exempt from any of the provisions of the FD&C Act related to the production of drugs, and the compounding provisions of the FD&C Act do not address repackaging. Therefore, the FDA is issuing guidance to describe how it intends to address repackaging when done in a state-licensed pharmacy, federal facility, or outsourcing facility.
Draft Guidance for Industry: Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (BLA)
The draft guidance describes the conditions under which the FDA does not intend to take action for violations of certain sections of the Public Health Service Act (PHS Act) and the FD&C Act when state-licensed pharmacies, federal facilities or outsourcing facilities mix, dilute or repackage specific biological products without an approved BLA, or when such facilities or physicians prepare prescription sets of allergenic extracts (used to treat allergies) without an approved BLA. The draft guidance notes that a biological product that is mixed, diluted or repackaged outside the scope of an approved BLA is an unlicensed biological product under section 351 of the PHS Act and may not be legally marketed without an approved BLA. Additionally, the compounding provisions of the FD&C Act do not address biological products subject to licensure under section 351 of the PHS Act. Therefore, the FDA is issuing guidance to describe how it intends to address these practices.
Draft Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act
Entities registered as outsourcing facilities are required to report adverse events to the FDA. The draft guidance explains adverse event reporting for outsourcing facilities.
Draft Memorandum of Understanding Between A State and the U.S. Food and Drug Administration Addressing Certain Distributions of Compounded Human Drug Products
The draft MOU under section 503A of the FD&C Act describes the responsibilities of a state that chooses to sign the MOU in investigating and responding to complaints related to compounded human drug products distributed outside the state, and in addressing the interstate distribution of “inordinate amounts” of compounded human drug products.
These documents are the latest in a series of policy documents related to FDA oversight of drugs produced by state-licensed pharmacies, federal facilities and outsourcing facilities.
The draft guidance documents are available for public comment for 90 days. The public has 120 days to comment on the draft MOU between the states and the FDA.
The new category of outsourcing facilities was created under the Drug Quality and Security Act (DQSA), enacted by Congress in November 2013 in response to a deadly fungal meningitis outbreak that was linked to contaminated sterile compounded drug products. Drugs compounded in an outsourcing facility that meet certain conditions may be entitled to exemptions from certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including the new drug approval requirements and the requirement to label drug products with adequate directions for use. Outsourcing facilities are subject to current good manufacturing practice requirements and inspections by the FDA according to a risk-based schedule.
Drugs produced by compounders that are not registered as outsourcing facilities must meet certain other conditions described in the FD&C Act, or they will be subject to all of the requirements applicable to drugs produced by conventional drug manufacturers.
“The draft guidance documents provide information to pharmacies, outsourcing facilities, health care entities, and others about these FDA-proposed policies, which are critical to protecting the public health,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
The documents are:
Draft Guidance: For Entities Considering Whether to Register As Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act
The draft guidance provides an entity considering whether to register with the FDA as an outsourcing facility under the law with information about the regulatory impact of registering. For example, it explains that a facility engaged in only certain activities, including repackaging human drugs and compounding non-sterile drugs, should not register as an outsourcing facility because its drug products will not qualify for the exemptions provided in section 503B, including the exemption from the new drug approval requirements.
Draft Guidance for Industry: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities
The draft guidance describes the conditions under which the FDA does not intend to take action for certain violations of the law when state-licensed pharmacies, federal facilities or outsourcing facilities repackage certain drug products. Repackaging generally involves taking a finished drug product from the container in which it was distributed by the original manufacturer and placing it into a different container. Repackaged drug products are generally not exempt from any of the provisions of the FD&C Act related to the production of drugs, and the compounding provisions of the FD&C Act do not address repackaging. Therefore, the FDA is issuing guidance to describe how it intends to address repackaging when done in a state-licensed pharmacy, federal facility, or outsourcing facility.
Draft Guidance for Industry: Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (BLA)
The draft guidance describes the conditions under which the FDA does not intend to take action for violations of certain sections of the Public Health Service Act (PHS Act) and the FD&C Act when state-licensed pharmacies, federal facilities or outsourcing facilities mix, dilute or repackage specific biological products without an approved BLA, or when such facilities or physicians prepare prescription sets of allergenic extracts (used to treat allergies) without an approved BLA. The draft guidance notes that a biological product that is mixed, diluted or repackaged outside the scope of an approved BLA is an unlicensed biological product under section 351 of the PHS Act and may not be legally marketed without an approved BLA. Additionally, the compounding provisions of the FD&C Act do not address biological products subject to licensure under section 351 of the PHS Act. Therefore, the FDA is issuing guidance to describe how it intends to address these practices.
Draft Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act
Entities registered as outsourcing facilities are required to report adverse events to the FDA. The draft guidance explains adverse event reporting for outsourcing facilities.
Draft Memorandum of Understanding Between A State and the U.S. Food and Drug Administration Addressing Certain Distributions of Compounded Human Drug Products
The draft MOU under section 503A of the FD&C Act describes the responsibilities of a state that chooses to sign the MOU in investigating and responding to complaints related to compounded human drug products distributed outside the state, and in addressing the interstate distribution of “inordinate amounts” of compounded human drug products.
These documents are the latest in a series of policy documents related to FDA oversight of drugs produced by state-licensed pharmacies, federal facilities and outsourcing facilities.
The draft guidance documents are available for public comment for 90 days. The public has 120 days to comment on the draft MOU between the states and the FDA.
11
Pharmacy / FDA Approves Glyxambi: SGLT2 and DPP-4 inhibitor
« on: March 15, 2015, 04:27:53 PM »
Glyxambi is the first prescription medication in U.S. to combine the dual mechanisms of action of SGLT2 and DPP-4 inhibitors.
The U.S. Food and Drug Administration (FDA) has approved Glyxambi (empagliflozin/linagliptin), a once-daily sodium glucose co-transporter-2 (SGLT2) inhibitor and dipeptidyl peptidase-4 (DPP-4) inhibitor fixed-dose combination for the treatment of adults with type 2 diabetes.
Medication Guide
Read this Medication Guide carefully before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. If you have any questions, ask your doctor or pharmacist.
Important information
Serious side effects can happen to people taking Glyxambi, including:
Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis. Before you start treatment, tell your doctor if you have ever had:
inflammation of your pancreas (pancreatitis)
stones in your gallbladder (gallstones)
a history of alcoholism
high blood triglyceride levels
Stop treatment and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.
Dehydration. Glyxambi can cause some people to have dehydration (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, light-headed, or weak, especially when you stand up (orthostatic hypotension).
You may be at higher risk of dehydration if you:
have low blood pressure
take medicines to lower your blood pressure, including diuretics (water pill)
are on low sodium (salt) diet
have kidney problems
are 65 years of age or older
Vaginal yeast infection. Women who take Glyxambi may get vaginal yeast infections. Symptoms of a vaginal yeast infection include:
vaginal odor
white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese)
vaginal itching
Yeast infection of the penis (balanitis or balanoposthitis). Men who take Glyxambi may get a yeast infection of the skin around the penis. Men who are not circumcised may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis. Other symptoms of yeast infection of the penis include:
redness, itching, or swelling of the penis
rash of the penis
foul smelling discharge from the penis
pain in the skin around penis
Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or penis. Your doctor may tell you to use an over-the-counter antifungal medicine. Talk to your doctor right away if you use an over-the-counter antifungal medicine and your symptoms do not go away.
The U.S. Food and Drug Administration (FDA) has approved Glyxambi (empagliflozin/linagliptin), a once-daily sodium glucose co-transporter-2 (SGLT2) inhibitor and dipeptidyl peptidase-4 (DPP-4) inhibitor fixed-dose combination for the treatment of adults with type 2 diabetes.
Medication Guide
Read this Medication Guide carefully before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. If you have any questions, ask your doctor or pharmacist.
Important information
Serious side effects can happen to people taking Glyxambi, including:
Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis. Before you start treatment, tell your doctor if you have ever had:
inflammation of your pancreas (pancreatitis)
stones in your gallbladder (gallstones)
a history of alcoholism
high blood triglyceride levels
Stop treatment and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.
Dehydration. Glyxambi can cause some people to have dehydration (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, light-headed, or weak, especially when you stand up (orthostatic hypotension).
You may be at higher risk of dehydration if you:
have low blood pressure
take medicines to lower your blood pressure, including diuretics (water pill)
are on low sodium (salt) diet
have kidney problems
are 65 years of age or older
Vaginal yeast infection. Women who take Glyxambi may get vaginal yeast infections. Symptoms of a vaginal yeast infection include:
vaginal odor
white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese)
vaginal itching
Yeast infection of the penis (balanitis or balanoposthitis). Men who take Glyxambi may get a yeast infection of the skin around the penis. Men who are not circumcised may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis. Other symptoms of yeast infection of the penis include:
redness, itching, or swelling of the penis
rash of the penis
foul smelling discharge from the penis
pain in the skin around penis
Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or penis. Your doctor may tell you to use an over-the-counter antifungal medicine. Talk to your doctor right away if you use an over-the-counter antifungal medicine and your symptoms do not go away.
12
Pharmacy / FDA Approves VenaSeal Closure System to Permanently Treat Varicose Veins
« on: March 15, 2015, 04:25:56 PM »
The U.S. Food and Drug Administration today approved the VenaSeal closure system (VenaSeal system) to permanently treat varicose veins of the legs by sealing the affected superficial veins using an adhesive agent.
There are two types of veins—deep veins and superficial veins. Superficial veins are those that are close to the skin. Veins contain one-way valves that open to let blood flow through and then shut to keep blood from flowing backward. When valves of the superficial system are weak or damaged, blood can back up and pool, which can cause varicose veins that are enlarged, swollen or twisted.
Varicose veins often cause no symptoms but some patients may experience mild to moderate pain, blood clots, skin ulcers or other problems, according to the National Heart, Lung, and Blood Institute at the National Institutes of Health. If these issues occur, health care professionals may recommend treatment such as compression stockings or medical procedures to remove or close the affected veins.
The VenaSeal system is intended for patients with superficial varicose veins of the legs that cause symptoms. The sterile kit is made up of an adhesive, a specially formulated n-butyl-2-cyanoacrylate, and delivery system components that include a catheter, guidewire, dispenser gun, dispenser tips, and syringes.
The device must be used as a system and differs from procedures that use drugs, laser, radio waves or cuts in the skin to close or remove veins. A trained healthcare professional inserts the catheter through the skin into the diseased vein to allow injection of the VenaSeal adhesive, a clear liquid that polymerizes into solid material. The healthcare professional monitors proper placement of the catheter using ultrasound imaging during delivery of the adhesive into the diseased vein to seal it.
“This new system is the first to permanently treat varicose veins by sealing them with an adhesive, thereby giving patients another treatment option for this common condition,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “Because the VenaSeal system does not incorporate heat application or cutting, the in-office procedure can allow patients to quickly return to their normal activities, with less bruising.”
The FDA reviewed data for the VenaSeal system in a premarket approval application, the agency’s pathway to evaluate safety and effectiveness of Class III medical devices. Data supporting the FDA approval included results from three clinical studies sponsored by the manufacturer. The U.S. clinical study assessed the safety and effectiveness of the VenaSeal system in 108 participants compared to radio-frequency ablation in 114 participants. The trials showed the device to be safe and effective for vein closure for the treatment of symptomatic superficial varicose veins of the legs.
The VenaSeal system should not be used in patients who have a known hypersensitivity to the VenaSeal adhesive, acute inflammation of the veins due to blood clots or acute whole-body infection. Adverse events observed in the trial—and generally associated with treatments of this condition—included vein inflammation (phlebitis) and burning or tingling (paresthesia) in the treatment zone.
The VenaSeal Closure system is manufactured by Covidien LLC, based in Morrisville, North Carolina.
There are two types of veins—deep veins and superficial veins. Superficial veins are those that are close to the skin. Veins contain one-way valves that open to let blood flow through and then shut to keep blood from flowing backward. When valves of the superficial system are weak or damaged, blood can back up and pool, which can cause varicose veins that are enlarged, swollen or twisted.
Varicose veins often cause no symptoms but some patients may experience mild to moderate pain, blood clots, skin ulcers or other problems, according to the National Heart, Lung, and Blood Institute at the National Institutes of Health. If these issues occur, health care professionals may recommend treatment such as compression stockings or medical procedures to remove or close the affected veins.
The VenaSeal system is intended for patients with superficial varicose veins of the legs that cause symptoms. The sterile kit is made up of an adhesive, a specially formulated n-butyl-2-cyanoacrylate, and delivery system components that include a catheter, guidewire, dispenser gun, dispenser tips, and syringes.
The device must be used as a system and differs from procedures that use drugs, laser, radio waves or cuts in the skin to close or remove veins. A trained healthcare professional inserts the catheter through the skin into the diseased vein to allow injection of the VenaSeal adhesive, a clear liquid that polymerizes into solid material. The healthcare professional monitors proper placement of the catheter using ultrasound imaging during delivery of the adhesive into the diseased vein to seal it.
“This new system is the first to permanently treat varicose veins by sealing them with an adhesive, thereby giving patients another treatment option for this common condition,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “Because the VenaSeal system does not incorporate heat application or cutting, the in-office procedure can allow patients to quickly return to their normal activities, with less bruising.”
The FDA reviewed data for the VenaSeal system in a premarket approval application, the agency’s pathway to evaluate safety and effectiveness of Class III medical devices. Data supporting the FDA approval included results from three clinical studies sponsored by the manufacturer. The U.S. clinical study assessed the safety and effectiveness of the VenaSeal system in 108 participants compared to radio-frequency ablation in 114 participants. The trials showed the device to be safe and effective for vein closure for the treatment of symptomatic superficial varicose veins of the legs.
The VenaSeal system should not be used in patients who have a known hypersensitivity to the VenaSeal adhesive, acute inflammation of the veins due to blood clots or acute whole-body infection. Adverse events observed in the trial—and generally associated with treatments of this condition—included vein inflammation (phlebitis) and burning or tingling (paresthesia) in the treatment zone.
The VenaSeal Closure system is manufactured by Covidien LLC, based in Morrisville, North Carolina.
13
Pharmacy / FDA Approves Unituxin (dinutuximab) for Pediatric High-Risk Neuroblastoma
« on: March 15, 2015, 04:24:07 PM »
the U. S. Food and Drug Administration approved dinutuximab (Unituxin, United Therapeutics Corporation), in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. Dinutuximab is a chimeric monoclonal antibody (also known as ch 14.18), composed of a combination of mouse and human DNA.
The approval was based on demonstration of improved event-free survival (EFS) and overall survival (OS) in a multicenter, open-label, randomized trial conducted by the Children’s Oncology Group. Prior to enrollment, patients had achieved at least a partial response to prior therapy for newly diagnosed high-risk neuroblastoma, consisting of induction combination chemotherapy, maximum feasible surgical resection, and myeloablative consolidation chemotherapy, and also received autologous stem cell transplant and radiation therapy.
The trial randomized (1:1) 226 patients to either the dinutuximab/RA arm or the RA alone arm. Patients in each arm received six cycles of treatment. The dinutuximab/RA arm consisted of dinutuximab in combination with GM-CSF and RA (cycles 1, 3, and 5), dinutuximab in combination with IL-2 and RA (cycles 2 and 4), and RA (cycle 6). Patients were 11 months to 15 years of age (median age 3.8 years).
The major efficacy outcome measure was investigator-assessed EFS, defined as the time from randomization to the first occurrence of relapse, progressive disease, secondary malignancy, or death. At the seventh interim analysis, an improvement in EFS [HR 0.57 (95% CI: 0.37, 0.89); p = 0.01, log-rank test] was demonstrated and four remaining patients undergoing treatment on the RA arm crossed over to receive dinutuximab/RA. The median EFS was not reached (3.4 years, NR) in the dinutuximab/RA arm and was 1.9 years (1.3, NR) in the RA arm. An analysis of overall survival (OS) conducted three years later documented an improvement in OS in the dinutuximab/RA arm compared to the RA arm [HR 0.58 (95% CI: 0.37, 0.91)]. At the time of this survival analysis, median OS had not been reached in either arm.
Safety data was evaluated in 134 patients. The most common (greater than or equal to 25%) adverse drug reactions in the dinutuximab/RA group were pain, pyrexia, thrombocytopenia, infusion reactions, hypotension, hyponatremia, increased alanine aminotransferase, anemia, vomiting, diarrhea, hypokalemia, capillary leak syndrome, neutropenia, urticaria, hypoalbuminemia, increased aspartate aminotransferase, and hypocalcemia. The most common (greater than or equal to 5%) serious adverse reactions in the dinutuximab/RA group were infections, infusion reactions, hypokalemia, hypotension, pain, fever, and capillary leak syndrome.
Seventy-one percent of patients in the dinutuximab/RA arm and 77% of patients in the RA alone arm completed planned treatment. The most common reason for premature discontinuation of study therapy was adverse reactions in the dinutuximab/RA group (19%) and progressive disease (17%) in the RA group.
The recommended dose and schedule for dinutuximab is 17.5 mg/m2/day as a diluted intravenous infusion over 10 to 20 hours for 4 consecutive days for up to 5 cycles. Patients require intravenous treatment with opioids prior to, during, and for 2 hours following the dinutuximab infusion to mitigate neuropathic pain. Patients also require prehydration and premedication to decrease the risk of hypotension and serious infusion reactions with dinutuximab.
Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125516s000lbl.pdf
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).
Unituxin is a trademark of United Therapeutics Corporation.
Source: U.S. Food and Drug Administration (FDA)
The approval was based on demonstration of improved event-free survival (EFS) and overall survival (OS) in a multicenter, open-label, randomized trial conducted by the Children’s Oncology Group. Prior to enrollment, patients had achieved at least a partial response to prior therapy for newly diagnosed high-risk neuroblastoma, consisting of induction combination chemotherapy, maximum feasible surgical resection, and myeloablative consolidation chemotherapy, and also received autologous stem cell transplant and radiation therapy.
The trial randomized (1:1) 226 patients to either the dinutuximab/RA arm or the RA alone arm. Patients in each arm received six cycles of treatment. The dinutuximab/RA arm consisted of dinutuximab in combination with GM-CSF and RA (cycles 1, 3, and 5), dinutuximab in combination with IL-2 and RA (cycles 2 and 4), and RA (cycle 6). Patients were 11 months to 15 years of age (median age 3.8 years).
The major efficacy outcome measure was investigator-assessed EFS, defined as the time from randomization to the first occurrence of relapse, progressive disease, secondary malignancy, or death. At the seventh interim analysis, an improvement in EFS [HR 0.57 (95% CI: 0.37, 0.89); p = 0.01, log-rank test] was demonstrated and four remaining patients undergoing treatment on the RA arm crossed over to receive dinutuximab/RA. The median EFS was not reached (3.4 years, NR) in the dinutuximab/RA arm and was 1.9 years (1.3, NR) in the RA arm. An analysis of overall survival (OS) conducted three years later documented an improvement in OS in the dinutuximab/RA arm compared to the RA arm [HR 0.58 (95% CI: 0.37, 0.91)]. At the time of this survival analysis, median OS had not been reached in either arm.
Safety data was evaluated in 134 patients. The most common (greater than or equal to 25%) adverse drug reactions in the dinutuximab/RA group were pain, pyrexia, thrombocytopenia, infusion reactions, hypotension, hyponatremia, increased alanine aminotransferase, anemia, vomiting, diarrhea, hypokalemia, capillary leak syndrome, neutropenia, urticaria, hypoalbuminemia, increased aspartate aminotransferase, and hypocalcemia. The most common (greater than or equal to 5%) serious adverse reactions in the dinutuximab/RA group were infections, infusion reactions, hypokalemia, hypotension, pain, fever, and capillary leak syndrome.
Seventy-one percent of patients in the dinutuximab/RA arm and 77% of patients in the RA alone arm completed planned treatment. The most common reason for premature discontinuation of study therapy was adverse reactions in the dinutuximab/RA group (19%) and progressive disease (17%) in the RA group.
The recommended dose and schedule for dinutuximab is 17.5 mg/m2/day as a diluted intravenous infusion over 10 to 20 hours for 4 consecutive days for up to 5 cycles. Patients require intravenous treatment with opioids prior to, during, and for 2 hours following the dinutuximab infusion to mitigate neuropathic pain. Patients also require prehydration and premedication to decrease the risk of hypotension and serious infusion reactions with dinutuximab.
Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125516s000lbl.pdf
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).
Unituxin is a trademark of United Therapeutics Corporation.
Source: U.S. Food and Drug Administration (FDA)
14
Pharmacy / Fighting Allergy Season with Medications
« on: March 15, 2015, 04:22:30 PM »
About Allergies
An allergy is a heightened immune system reaction to a substance that your body has identified as an invader. If you have allergies and encounter a trigger—called an “allergen”—your immune system fights it by making antibodies, which causes your body to release chemicals called histamines. Histamines are responsible for symptoms such as repetitive sneezing and itchy, watery eyes.
Allergic rhinitis affects more than 30 million children and adults in the United States and more than 500 million people worldwide. It may be seasonal or year-round.
The seasonal allergy, often called “hay fever,“ typically occurs in the spring, summer or fall. If you have this, you may suffer from repetitive sneezing, and stuffy or runny nose and itching in the nose, eyes or on the roof of the mouth. Eye inflammation can occur when your eyes react to allergens with symptoms of reddening, itching and swelling.
Plant pollens usually cause seasonal allergies. Pollen allergies are common, and allergy-causing pollen can come from trees, weeds and grasses, according to the National Institute of Allergy and Infectious Diseases. Trees and grasses are typical spring culprits in the United States, while ragweed and other weeds ramp up in late summer and early fall.
Indoor substances, such as dust mites, often cause the year-round type of allergies. Molds can cause seasonal and year-round allergies.
back to top
Testing
If you suspect an allergy, see your health care provider, as conditions such as upper respiratory infections, sinus infections and eye infections can have similar symptoms.
“The first step is to get appropriate testing to determine what you’re actually reacting to,” says Jay Slater, M.D., an allergist and director of FDA’s Division of Bacterial, Parasitic and Allergenic Products.
Your health care provider can test you using injectable allergen extracts. Allergen extracts are sterile liquids made from natural substances such as molds, pollens or animal hair. FDA has licensed these products. Tests include:
a skin prick test, which involves placing the allergen extract on your skin and pricking so it goes under the skin’s surface. Your skin is studied for swelling or other signs of a reaction, which usually occurs in about 15 minutes.
an injection of a small amount of an allergen, or
a blood test, which can detect and measure antibodies to certain allergens.
back to top
Medications to Treat Symptoms
“After testing, you need to sort out results with your health care provider,” Slater says. “Take the results of the test and combine it with reflective thinking about when and where you’re experiencing symptoms. Then determine the best course of action.”
For instance, if you have a spring oak tree allergy you can try to avoid the allergen by limiting outdoor activities on high pollen-count days and keeping your windows closed. But airborne pollen can be hard to avoid, so your health care provider may also recommend prescription or over-the-counter medications to relieve symptoms.
Antihistamines reduce or block symptom-causing histamines and are available in many forms, including tablets and liquids.
“There are several different antihistamines. First-generation antihistamines include medications such as diphenhydramine, marketed under the brand name Benadryl. They have been available over the counter for a long time,” says Narayan Nair, M.D., a medical officer at FDA. “Newer second generation antihistamines have not been available over the counter as long. They include medications such as fexofenadine and loratadine, which are marketed under the brand names Allegra and Claritin, respectively.”
When choosing an over-the-counter antihistamine, patients should read the Drug Facts label closely and follow dosing instructions, Nair says. “Some antihistamines can cause drowsiness and interfere with the ability to drive or operate heavy machinery. The drowsiness can be made worse by taking sedatives or consuming alcohol,” he explains. “Also, patients with chronic conditions such as glaucoma, or an enlarged prostate should talk to their health care provider before taking certain antihistamines.”
In addition to the antihistamines, nasal sprays and eye drops can help improve some allergic symptoms. “Nasal sprays can help relieve nasal symptoms but they should only be used for a limited time without talking to a health care provider. If some nasal sprays are used longer than intended they can make the congestion worse,” Nair notes.
back to top
Medications that Help Desensitize
If you don’t respond to medications to relieve symptoms, you may be a candidate for allergen immunotherapy, often given via “allergy shots” that have small amounts of the allergen. These shots can decrease sensitivity to inhaled allergens.
Patients can receive weekly injections from a health care provider for two to three months, during which time the dose increases, Slater says. After the maximum dose is reached, treatment can continue monthly for three to five years.
The prescription sublingual treatments approved in April—Grastek, Oralair, and Ragwitek—also are an immunotherapy option. “These medications have the potential for dialing down the immune response to allergens, doing more than just treating the symptoms of allergies,” says Slater. Sublingual therapy should start three to four months prior to allergy season so, depending on your geographic location, it may be something to explore in the next year.
Allergenic treatments can result in reactions such as swelling in the place where they are administered, or systemic reactions that can affect the airway. “For injection therapy, local side effects like itching and swelling can be annoying but not life-threatening,” Slater explains. But for the medications taken under the tongue, you must be especially careful to pay attention to side effects such as swelling.
Due to the potential for serious complications, you must take the first sublingual treatment under medical supervision. After that, you can take treatments daily at home, and your health care provider must prescribe an autoinjectable epinephrine device in case you need it for a severe reaction. You should read the medication guide that is distributed with Grastek, Oralair and Ragwitek each time you fill a prescription.
“For sublingual therapy, the fact that it’s not an injection will be an advantage to some individuals. And the fact that, aside from the first visit, it doesn’t require follow-up office visits will also be an advantage,” Slater says.
“What’s limiting for sublingual therapy compared to injection therapy is the availability of products. Now, we have sublingual medications for treatment of allergic rhinitis with or without conjunctivitis caused by short ragweed and certain grass pollens, but plenty of other substances induce allergies and affect people, sometimes dramatically,” Slater continues. “With injection immunotherapy, health care providers have more flexibility in terms of treating patients who may have multiple allergies or allergies not covered by sublingual products.”
An allergy is a heightened immune system reaction to a substance that your body has identified as an invader. If you have allergies and encounter a trigger—called an “allergen”—your immune system fights it by making antibodies, which causes your body to release chemicals called histamines. Histamines are responsible for symptoms such as repetitive sneezing and itchy, watery eyes.
Allergic rhinitis affects more than 30 million children and adults in the United States and more than 500 million people worldwide. It may be seasonal or year-round.
The seasonal allergy, often called “hay fever,“ typically occurs in the spring, summer or fall. If you have this, you may suffer from repetitive sneezing, and stuffy or runny nose and itching in the nose, eyes or on the roof of the mouth. Eye inflammation can occur when your eyes react to allergens with symptoms of reddening, itching and swelling.
Plant pollens usually cause seasonal allergies. Pollen allergies are common, and allergy-causing pollen can come from trees, weeds and grasses, according to the National Institute of Allergy and Infectious Diseases. Trees and grasses are typical spring culprits in the United States, while ragweed and other weeds ramp up in late summer and early fall.
Indoor substances, such as dust mites, often cause the year-round type of allergies. Molds can cause seasonal and year-round allergies.
back to top
Testing
If you suspect an allergy, see your health care provider, as conditions such as upper respiratory infections, sinus infections and eye infections can have similar symptoms.
“The first step is to get appropriate testing to determine what you’re actually reacting to,” says Jay Slater, M.D., an allergist and director of FDA’s Division of Bacterial, Parasitic and Allergenic Products.
Your health care provider can test you using injectable allergen extracts. Allergen extracts are sterile liquids made from natural substances such as molds, pollens or animal hair. FDA has licensed these products. Tests include:
a skin prick test, which involves placing the allergen extract on your skin and pricking so it goes under the skin’s surface. Your skin is studied for swelling or other signs of a reaction, which usually occurs in about 15 minutes.
an injection of a small amount of an allergen, or
a blood test, which can detect and measure antibodies to certain allergens.
back to top
Medications to Treat Symptoms
“After testing, you need to sort out results with your health care provider,” Slater says. “Take the results of the test and combine it with reflective thinking about when and where you’re experiencing symptoms. Then determine the best course of action.”
For instance, if you have a spring oak tree allergy you can try to avoid the allergen by limiting outdoor activities on high pollen-count days and keeping your windows closed. But airborne pollen can be hard to avoid, so your health care provider may also recommend prescription or over-the-counter medications to relieve symptoms.
Antihistamines reduce or block symptom-causing histamines and are available in many forms, including tablets and liquids.
“There are several different antihistamines. First-generation antihistamines include medications such as diphenhydramine, marketed under the brand name Benadryl. They have been available over the counter for a long time,” says Narayan Nair, M.D., a medical officer at FDA. “Newer second generation antihistamines have not been available over the counter as long. They include medications such as fexofenadine and loratadine, which are marketed under the brand names Allegra and Claritin, respectively.”
When choosing an over-the-counter antihistamine, patients should read the Drug Facts label closely and follow dosing instructions, Nair says. “Some antihistamines can cause drowsiness and interfere with the ability to drive or operate heavy machinery. The drowsiness can be made worse by taking sedatives or consuming alcohol,” he explains. “Also, patients with chronic conditions such as glaucoma, or an enlarged prostate should talk to their health care provider before taking certain antihistamines.”
In addition to the antihistamines, nasal sprays and eye drops can help improve some allergic symptoms. “Nasal sprays can help relieve nasal symptoms but they should only be used for a limited time without talking to a health care provider. If some nasal sprays are used longer than intended they can make the congestion worse,” Nair notes.
back to top
Medications that Help Desensitize
If you don’t respond to medications to relieve symptoms, you may be a candidate for allergen immunotherapy, often given via “allergy shots” that have small amounts of the allergen. These shots can decrease sensitivity to inhaled allergens.
Patients can receive weekly injections from a health care provider for two to three months, during which time the dose increases, Slater says. After the maximum dose is reached, treatment can continue monthly for three to five years.
The prescription sublingual treatments approved in April—Grastek, Oralair, and Ragwitek—also are an immunotherapy option. “These medications have the potential for dialing down the immune response to allergens, doing more than just treating the symptoms of allergies,” says Slater. Sublingual therapy should start three to four months prior to allergy season so, depending on your geographic location, it may be something to explore in the next year.
Allergenic treatments can result in reactions such as swelling in the place where they are administered, or systemic reactions that can affect the airway. “For injection therapy, local side effects like itching and swelling can be annoying but not life-threatening,” Slater explains. But for the medications taken under the tongue, you must be especially careful to pay attention to side effects such as swelling.
Due to the potential for serious complications, you must take the first sublingual treatment under medical supervision. After that, you can take treatments daily at home, and your health care provider must prescribe an autoinjectable epinephrine device in case you need it for a severe reaction. You should read the medication guide that is distributed with Grastek, Oralair and Ragwitek each time you fill a prescription.
“For sublingual therapy, the fact that it’s not an injection will be an advantage to some individuals. And the fact that, aside from the first visit, it doesn’t require follow-up office visits will also be an advantage,” Slater says.
“What’s limiting for sublingual therapy compared to injection therapy is the availability of products. Now, we have sublingual medications for treatment of allergic rhinitis with or without conjunctivitis caused by short ragweed and certain grass pollens, but plenty of other substances induce allergies and affect people, sometimes dramatically,” Slater continues. “With injection immunotherapy, health care providers have more flexibility in terms of treating patients who may have multiple allergies or allergies not covered by sublingual products.”
15
Pharmacy / Newer Blood Thinner May Improve Outcomes for Heart Attack Survivors
« on: March 15, 2015, 04:21:08 PM »
Long-term use of the newer anti-clotting drug Brilinta cut heart attack survivors' future risk of heart attack, stroke or heart-related death, a new study found.
The study was funded by Brilinta's maker, AstraZeneca, and was scheduled for presentation Saturday in San Diego at the annual meeting of the American College of Cardiology (ACC).
One expert not connected to the new study said the findings are encouraging, even though Brilinta typically costs more than older, generic blood thinners.
Long-term cost savings -- due to Brilinta users avoiding more heart attacks or strokes -- "might help offset the upfront cost of Brilinta compared to generic anti-clotting agents," explained Dr. David Friedman, chief of heart failure services at North Shore-LIJ's Franklin Hospital in Valley Stream, N.Y.
The new study was led by Dr. Marc Sabatine, a cardiologist at Brigham and Women's Hospital and Harvard Medical School in Boston. His team tracked outcomes for more than 21,000 people across 31 countries. All of the study participants had survived a heart attack in the previous one to three years.
The patients also had other factors, such as diabetes or older age, that put them at risk for another heart attack and were taking aspirin as a preventive measure, the study authors said.
Patients randomly received a twice-daily dose of either 90 milligrams (mg) of Brilinta (ticagrelor), 60 mg of the drug, or an inactive placebo. All of them kept taking low-dose aspirin, a standard therapy.
Over an average follow-up of about three years, the risk of heart attack, stroke and heart-related death was 15 percent lower among those who took the 90-mg dose of Brilinta and 16 percent lower among those who took the 60-mg dose of the drug, compared with those who took the placebo, the team said.
The study was published online Saturday in the New England Journal of Medicine. Sabatine has received payments from AstraZeneca.
"The benefit we saw [from Brilinta] was remarkably consistent across the individual components of [heart health events] and in all the major subgroups of patients," Sabatine said in an ACC news release.
About 7 percent of the study patients stopped taking Brilinta due to bleeding, and about 5 percent stopped taking it due to shortness of breath, the findings showed.
The twice-daily, 90-mg dose of Brilinta is already approved to treat acute coronary syndrome, a form of heart disease, the study authors said in the news release.
Dr. Kirk Garratt is director of interventional cardiovascular research at Lenox Hill Hospital in New York City. He explained that "after a heart attack, people are at high risk of another one. We know medicines like Brilinta and low-dose aspirin help lower the risk over a year or so, but this study confirms that continuing dual anti-clotting therapy for up to three years is helpful."
And although "bleeding was higher with longer [Brilinta] treatment, it wasn't seen at rates that would be especially worrisome," Garratt added.
"It's also nice to see that a somewhat lower dose of 60 mg produced as much benefit as the higher 90-mg dose," Garratt said. "Even though bleeding rates weren't very different between these doses, clinicians will be happy to have access to a lower dose.
The study was funded by Brilinta's maker, AstraZeneca, and was scheduled for presentation Saturday in San Diego at the annual meeting of the American College of Cardiology (ACC).
One expert not connected to the new study said the findings are encouraging, even though Brilinta typically costs more than older, generic blood thinners.
Long-term cost savings -- due to Brilinta users avoiding more heart attacks or strokes -- "might help offset the upfront cost of Brilinta compared to generic anti-clotting agents," explained Dr. David Friedman, chief of heart failure services at North Shore-LIJ's Franklin Hospital in Valley Stream, N.Y.
The new study was led by Dr. Marc Sabatine, a cardiologist at Brigham and Women's Hospital and Harvard Medical School in Boston. His team tracked outcomes for more than 21,000 people across 31 countries. All of the study participants had survived a heart attack in the previous one to three years.
The patients also had other factors, such as diabetes or older age, that put them at risk for another heart attack and were taking aspirin as a preventive measure, the study authors said.
Patients randomly received a twice-daily dose of either 90 milligrams (mg) of Brilinta (ticagrelor), 60 mg of the drug, or an inactive placebo. All of them kept taking low-dose aspirin, a standard therapy.
Over an average follow-up of about three years, the risk of heart attack, stroke and heart-related death was 15 percent lower among those who took the 90-mg dose of Brilinta and 16 percent lower among those who took the 60-mg dose of the drug, compared with those who took the placebo, the team said.
The study was published online Saturday in the New England Journal of Medicine. Sabatine has received payments from AstraZeneca.
"The benefit we saw [from Brilinta] was remarkably consistent across the individual components of [heart health events] and in all the major subgroups of patients," Sabatine said in an ACC news release.
About 7 percent of the study patients stopped taking Brilinta due to bleeding, and about 5 percent stopped taking it due to shortness of breath, the findings showed.
The twice-daily, 90-mg dose of Brilinta is already approved to treat acute coronary syndrome, a form of heart disease, the study authors said in the news release.
Dr. Kirk Garratt is director of interventional cardiovascular research at Lenox Hill Hospital in New York City. He explained that "after a heart attack, people are at high risk of another one. We know medicines like Brilinta and low-dose aspirin help lower the risk over a year or so, but this study confirms that continuing dual anti-clotting therapy for up to three years is helpful."
And although "bleeding was higher with longer [Brilinta] treatment, it wasn't seen at rates that would be especially worrisome," Garratt added.
"It's also nice to see that a somewhat lower dose of 60 mg produced as much benefit as the higher 90-mg dose," Garratt said. "Even though bleeding rates weren't very different between these doses, clinicians will be happy to have access to a lower dose.