A number of recent studies have linked Permax—a drug used to treat symptoms of Parkinson's Disease—to life-threatening health risks including heart valve damage, causing the U.S. Food and Drug Administration to pull the drug off U.S. shelves in March 2007.
The drug manufacturer, Valeant Pharmaceuticals International, complied with the FDA recall and stopped all wholesale distribution of Permax (generically known as pergolide) after reports suggested the drug may cause leakage in the mitral, atrial, or tricuspid heart valves, resulting in potentially fatal damages.
Previous Permax Warnings
The FDA, in 2002, sent a warning to Valeant regarding the association between Permax and heart valve disease. The agency ordered the drug manufacturer to update the warning label on the drug to indicate these serious health risks.
By 2006, Permax was required to carry a “black-box” warning—the strongest FDA warning—after more reports revealed a significantly higher incidence of heart valve damage linked to the drug.
Over a dozen Permax patients so far have had to undergo extensive heart valve replacement surgery as a consequence of using the drug.
The FDA urges patients taking Permax to decrease dosages of the drug under the care of a medical professional. Permax won't be barred from being sold at pharmacies until an alternative Parkinson's drug is found.
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