Parkinson's Drug Taken Off Market
Permax Voluntarily Removed From Market Due to Risk of Heart Valve Problems
March 29, 2007 -- The FDA today announced that the Parkinson's disease drug Permax and its generic versions (pergolide) are being voluntarily taken off the U.S. market because of the risk of serious damage to the heart's valves.
Pergolide, approved by the FDA in 1988, already carried a "black box" warning on its label about the risk of leaky heart valves in the drug's users.
The drug's removal is based on two European studies showing that Parkinson's patients taking pergolide were about five times as likely to have leaky heart valves as those not taking pergolide.
WebMD reported on those studies in January 2007, when the studies appeared in The New England Journal of Medicine.
Advice for Patients
Patients shouldn't stop taking pergolide instantly. They should talk to their doctors first, says Robert Temple, MD, director of medical policy for the FDA's Center for Drug Evaluation and Research.
An estimated 12,000 people in the U.S. received pergolide prescriptions in 2006, according to the FDA. Temple says the drug's use had dropped in light of the heart valve risk.
Pergolide won't disappear from the market right away. It will be phased out to allow people to make other treatment plans.
"We didn't want to have people being completely without it abruptly," Temple says.
"The basic conclusion we've reached is that pergolide had no demonstrated or particularly plausible advantage over any of the other therapies for Parkinson's disease," Temple says.
The FDA is trying to reach an agreement with pergolide's makers to keep the drug available under certain restrictions for people "who find that they simply cannot be without the drug," Temple says.
He's not sure how many patients will be in that situation but expects such cases to be rare. "We believe almost all patients can be converted to another drug," Temple says.
Other Parkinson's Drugs Not Affected
Permax belongs to a class of drugs called dopamine agonists. Today's action doesn't affect any other dopamine agonists or other types of Parkinson's disease drugs.
"We believe that the dopamine agonists are a valuable part of the armamentarium for treating Parkinson's disease," says John Feeney III, MD, acting deputy director in the neurology products division of the FDA's Center for Drug Evaluation and Research.
"But there are other alternative dopamine agonists and there are, even beyond that, there are other available therapies for patients with Parkinson's disease," Feeney says.