Drugmaker Removes Parkinson's Disease Medication from the Market; Drug Linked to Heart Valve Damage

On March 29, 2007, Valeant Pharmaceuticals International withdrew the Parkinson’s disease drug pergolide (PERMAX) from the market. This follows the publication of two studies in the Jan. 4, 2007, New England Journal of Medicine (NEJM), which show an increased risk of heart valve damage in patients taking pergolide compared to those not taking the drug.

The FDA approved pergolide in December 1988 for use in combination with levodopa (LARODOPA) or the combination drug levodopa and carbidopa (SINEMET) for Parkinson’s disease.

The drug was on the market for more than a decade before three cases of heart valve problems were first reported in association with its use in 2002. In 2003, the FDA asked the drug’s manufacturer to add heart valve damage to the warning section of pergolide’s professional product labeling (also known as a package insert). The same year, the drug manufacturer also sent a letter to health care professionals about these dangers. In 2006, the warning was upgraded to a black box warning, the strongest type of warning that the FDA can request.

The recent NEJM study, finally precipitating the withdrawal of pergolide, found that 23.4 percent of patients using this drug had evidence of moderate to severe valve damage compared with no damage in patients with Parkinson’s disease using drugs not in the same chemical class (ergot-derived) as pergolide.

What You Can Do
You should contact your health care professional immediately if you are taking pergolide to discuss other treatments. Do not discontinue taking pergolide abruptly. The dosage of the drug must be gradually decreased.