----------------------------------------------------------- New Message on Pituitary Chat
----------------------------------------------------------- From: PTResearcher2 Message 1 in Discussion I have not been on the boards for several weeks and I had assumed this would have been posted by now, but since it wasn't and since it is important, I'll post the following information: FOR IMMEDIATE RELEASE P07-54 March 29, 2007 Media Inquiries: Sandy Walsh, 301-827-6242 Consumer Inquiries: 888-INFO-FDA FDA Announces Voluntary Withdrawal of Pergolide Products Agency Working with Product Manufacturers The U.S. Food and Drug Administration (FDA) today announced that manufacturers of pergolide drug products, which are used to treat Parkinsons 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 The products being withdrawn are Permax, the trade name for pergolide marketed by Valeant Pharmaceuticals, and two generic versions of pergolide manufactured by Par and Teva.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 Parkinsons 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 Parkinsons 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 FDAs Center for Drug Evaluation and Research. The FDAs 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 dont 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 Parkinsons 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 FDAs 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. http://www.fda.gov/bbs/topics/NEWS/2007/NEW01596.html ----------------------------------------------------------- To stop getting this e-mail, or change how often it arrives, go to your E-mail Settings. http://groups.msn.com/PituitaryChat/_emailsettings.msnw Need help? If you've forgotten your password, please go to Passport Member Services. http://groups.msn.com/_passportredir.msnw?ppmprop=help For other questions or feedback, go to our Contact Us page. http://groups.msn.com/contact If you do not want to receive future e-mail from this MSN group, or if you received this message by mistake, please click the "Remove" link below. 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