Mayo Clinic doctors say a drug for Parkinson’s disease could damage people’s heart valves in much the same way as the diet drug combination known as fen-phen.
Mayo physicians discovered heart valve disease in three women taking pergolide, or Permax, a drug used to treat restless-leg syndrome as well as Parkinson’s, according to a study released Tuesday.
They said the valve damage was “strikingly similar” to that found in patients taking fen-phen (fenfluramine and phentermine), the diet pill combo that was pulled off the market in 1997 after Mayo brought to light the valve problems.
“Given this possible association, we recommend that all patients taking pergolide undergo a thorough cardiovascular examination,” the authors reported in December’s Mayo Clinic Proceedings.
The drug’s manufacturer, Eli Lilly and Co., said it has received about a dozen reports of valve disease in the half-million patients who have taken Permax in the past 13 years. “We’re talking about very rare occurrences,” said Kindra Strupp, a corporate spokeswoman in Indianapolis.
But she said the company is changing its warning label to add that risk, at the request made by the U.S. Food and Drug Administration several weeks ago, about the same time that the company learned of the Mayo Clinic’s study.
“There’s not really a clear causal relationship,” she said of the findings. But “we just know that, given the nature of the reports, that it seems prudent to make sure we include this in our label.”
The report, by cardiologist Dr. Raul Espinosa and colleagues, urged patients to stop taking pergolide if valve disease is detected.
In an accompanying editorial, another cardiologist says the danger deserves notice. “Is the association with use of the drug real? Yes, until proved otherwise,” wrote Dr. Shahbudin Rahimtoola, a professor at the University of Southern California at Los Angeles.
“One could argue that this is a report of only three patients and that we should wait for more cases; however, try telling that to patients and families of those who subsequently develop [disease] that requires valve replacement.”
He said more research is needed to confirm the risk.
The drug has been known to pose risks to people with irregular heartbeats.