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.
The FDA approved Permax in 1988 for use with another drug, levodopa, in treating Parkinson's disease.
Reports of leaky heart valves in pergolide users first surfaced in 2002, and a warning about heart valve problems went on the drug's label in 2003.
That warning was strengthened to a "black box" warning -- the FDA's strongest warning -- in 2006, based on the previously mentioned European studies.
Those studies also showed a similar risk for another drug, cabergoline, in Parkinson's patients. But cabergoline isn't used to treat Parkinson's in the U.S., Temple notes.
Cabergoline is used in the U.S. "for a different purpose at a much, much lower dose" than the dose used in the European studies, Temple says. "We are not particularly worried about it."
Temple says the FDA requested pergolide's removal from the market and that the drug's makers agreed.
"I would say that there was pretty general agreement that the time for this drug had run out," Temple says.
Permax is marketed by Valeant Pharmaceuticals International. Generic pergolide is marketed by Par Pharmaceutical Companies and Teva Pharmaceuticals.