Pergolide Associated With Cardiac Valvulopathy

February 24, 2003

Medscape Staff Report

Feb. 24, 2003 — New reports of cardiac valvulopathy have been seen in patients receiving pergolide (Permax), a drug indicated to treat the signs and symptoms of Parkinson's disease, according to a letter to healthcare professionals from Eli Lilly and Co., the maker of Permax. The letter was posted on the U.S. Food and Drug Administration (FDA) Web site today.

In the cases of valvulopathy reported, the aortic, mitral, and tricuspid valves were involved. The letter did not specify the exact number of case, only "a small number of individuals." The letter went on to point out that 500,000 people have been treated with pergolide since 1989, and valvulopathy has been reported in less than 0.005%.

The warnings section of the drug's U.S. package insert will be modifed to reflect these recent reports.

To report adverse events with pergolide, healthcare professionals can call the FDA's MedWatch program (1-800-FDA-1088) or fill out a form online (https://www.accessdata.fda.gov/scripts/medwatch/).

Reviewed by Gary D. Vogin, MD

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