( The U.S. Food and Drug Administration (...)FDA Announces Voluntary Withdrawal of Pergolide Products,Health

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The products being withdrawn are Permax, the trade name for pergolide marketed by Valeant Pharmaceuticals, and two generic versions of pergolide manufactured by Par and Teva.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 regurgitat
'"/>




Page: 1 2
Related medicine news :

1. Ramdoss Announces Introduction of RCH-II
2. Britain Announces Third Transfusion Related Mad Cow Case
3. Tibet Announces the Dalai Lama’s Tour of South Americ
4. Indian PM Announces Of Setting Up India Study Center At Tashkent
5. PowderMed Announces Needle-Less Flu Vaccine
6. Malaysia Announces Prison term On People Donating HIV-Contaminated Blood
7. Gates Foundation Announces $287 Million In Grants Towards AIDS Vaccine
8. Australian Government Announces Survey To Tackle Childhood Obesity
9. New Zealand Announces 10-year Plan For Betterment Of Mental Health Care
10. Apollo Announces Research on Indian Cardiac Epidemic
11. Government Announces Steps To Promote Ayurvedic Medicine