منتدى الصيدلي
هل تريد التفاعل مع هذه المساهمة؟ كل ما عليك هو إنشاء حساب جديد ببضع خطوات أو تسجيل الدخول للمتابعة.

منتدى الصيدلي

منتدى الصييدلي
 
الرئيسيةالبوابةأحدث الصورالتسجيلدخول

 

 Withdrawal of Pergolide products

اذهب الى الأسفل 
كاتب الموضوعرسالة
ام على
مشرف
مشرف
ام على


عدد الرسائل : 192
sms : <!--- MySMS By AlBa7ar Semauae.com --><form method="POST" action="--WEBBOT-SELF--"> <!--webbot bot="SaveResults" u-file="fpweb:///_private/form_results.csv" s-format="TEXT/CSV" s-label-fields="TRUE" --><fieldset style="padding: 2; width:208; height:104"> <legend><b>My SMS</b></legend> <marquee onmouseover="this.stop()" onmouseout="this.start()" direction="up" scrolldelay="2" scrollamount="1" style="text-align: center; font-family: Tahoma; " height="78">$post[field5]</marquee></fieldset></form><!--- MySMS By AlBa7ar Semauae.com -->
تاريخ التسجيل : 22/03/2008

Withdrawal of Pergolide products Empty
مُساهمةموضوع: Withdrawal of Pergolide products   Withdrawal of Pergolide products Emptyالأربعاء مارس 26, 2008 10:31 pm

Withdrawal of Pergolide products


The U.S. Food and Drug Administration (FDA) today announced that manufacturers of pergolide drug products, which are used to treat Parkinson's disease, will voluntarily remove these drugs from the market because of the risk of serious damage to patients' heart valves

The products being withdrawn are Permax, the trade name for pergolide marketed by Valeant Pharmaceuticals, and two generic versions of pergolide manufactured by Par and Teva. Pergolide is in a class of medications called dopamine agonists and is used with levodopa and carbidopa to manage the symptoms (tremors and slowness of movement) of Parkinson's disease

In 2006, an estimated 12,000 patients received prescriptions for pergolide from retail pharmacies in the United States. Patients taking pergolide should contact their doctors to discuss alternate treatments. Patients should not stop taking the medication, as stopping pergolide abruptly can be dangerous

There are alternative therapies available for Parkinson's disease, including three other dopamine agonists that have not been associated with valvular heart disease. The removal of pergolide products is not expected to adversely affect patient care because of the alternative therapies available

"Based on important new drug safety information, FDA has been working with the manufacturers of pergolide products to voluntarily remove these drugs from the market," said Douglas Throckmorton, M.D., deputy director of FDA's Center for Drug Evaluation and Research. "The FDA's increased evaluation of post-market safety is benefiting the public because, in this case, as new data about the product became available, we were able to remove a less safe drug from the market."

Two recent New England Journal of Medicine studies confirm previous findings associating pergolide with increased chance of regurgitation (backflow of blood) of the mitral, tricuspid, and aortic valves of the heart. Valve regurgitation is a condition in which valves don't close tightly, allowing blood to flow backward across the valve. Symptoms include shortness of breath, fatigue and heart palpitations

In light of this additional post-market safety information, the companies that manufacture and sell pergolide will stop shipping pergolide for distribution and, in cooperation with FDA, will withdraw the products from the market

Permax was approved in 1988 for Eli Lilly and Company as an adjunctive therapy with levodopa in Parkinson's disease. Valvular heart disease was first described in association with pergolide in 2002. In 2003, FDA asked Lilly to add valvulopathy (abnormality of cardiac valves) to the warnings section of Permax labeling, at which time a Dear Healthcare Practitioner letter was sent by Lilly. In 2006, the warning was upgraded to a black box warning, the FDA's strongest form of warning, because of new data concerning risks of heart valve damage

FDA today is issuing a Public Health Advisory (PHA) detailing the removal of pergolide products from the market. The PHA, which is available at www.fda.gov/cder/drug/advisory/ pergolide.htm includes information and recommended actions for physicians, pharmacists and patients

The effect of the voluntary withdrawal on supplies of pergolide currently in pharmacies will not be immediate. This delay will allow time for health care providers and patients to discuss appropriate treatment options and time to change treatments

FDA is working with the manufacturers of pergolide to determine if it might be possible, once the drug is withdrawn from the market, to make the drug available under an Investigational New Drug Application (IND) for those few patients who are currently receiving pergolide and who cannot be successfully converted to other available treatments
الرجوع الى أعلى الصفحة اذهب الى الأسفل
 
Withdrawal of Pergolide products
الرجوع الى أعلى الصفحة 
صفحة 1 من اصل 1

صلاحيات هذا المنتدى:لاتستطيع الرد على المواضيع في هذا المنتدى
منتدى الصيدلي :: منتدى الصيدلي :: عالم الأخبار الطبية-
انتقل الى: