Drugs & Medical Devices

PERMAX



On March 29, 2007, the FDA announced that Permax (generic: pergolide) is being pulled off the market. “There are additional drugs in the same class that can be substituted”, Dr. Robert Temple of the FDA’s office of drug evaluation said at a briefing. To date, 14 patients have needed to have heart valves replaced, Temple said, adding he believes that is a miscalculation. He estimates that between 12,000 and 25,000 people currently use Permax. Dr. Temple said withdrawal was demanded after two recent studies, published in The New England Journal of Medicine, indicated high rates of valve leakage, up to 20%, in patients prescribed Permax.
On January 3, 2007, new studies came out linking Permax with heart valve damage. A study by Italian researchers found that approximately one-fourth of Parkinson’s patients taking Permax had moderate to severe heart valve troubles. An additional study, by German doctors, established that users of Permax were five to seven times more likely to have leaky heart valves than those on other types of Parkinson’s medications. Both studies can be found in the New England Journal of Medicine.
In the Italian study, Dr. Renzo Zenettini and others at the Instituti Clinici di Perfezionamento in Milan obtained echocardiogram images of the hearts of 155 patients taking various Parkinson’s medications and a comparison group of 90 health people. Moderate to severe valve problems were seen in 23% of those on Permax. In the German study, Dr. Rene Schade and associates in Berlin and in Montreal used records from over 11,400 Parkinson’s patients in the United Kingdom. The rate of newly diagnosed leaky valves was increased among Permax users.
Permax (pergoglide) has been linked to serious heart damage. Cardiac valvulopathy involving one or more valves has resulted in some patients taking Permax. Permax is used to treat Parkinson’s disease. The details of the heart valve damage were detailed in a report by doctors at the Mayo Clinic. While the evidence in the report is based only on three (3) cases treated at the clinic, the doctors say their evidence is enough to recommend that anyone with heart problems not take Pergolide, which is sold as Permax and has been used since 1999 to treat the tremors and restless leg syndrome from which Parkinson’s disease patients suffer. “Further study is needed to see if this condition is under-recognized or, conversely, so rare it escapes attention,” says Dr. Raul Espinosa, a cardiologist at the Mayo Clinic and one of the authors of the report. But he and his colleagues write in the report that “Pergolide should be discontinued if valvular disease is detected and no other cause identified.”
Eli Lilly, the maker of the drug, says that Permax has had a safe record since coming on the market, but that the company would consider adding information about this heart risk to the label. In the cases that were treated at the clinic, three older women aged 61, 72 and 74 had been taking various doses of the Permax daily for between three and seven years to treat their Parkinson’s symptoms. They were diagnosed with serious valve disease; two required valve replacement surgery. None of the three had a prior history of heart disease. The findings led doctors back to their surgical records to see if any other people who had had valve replacement in the previous year had also been taking Pergolide. They found one out of 17 patients who had been on the drug. At the same time, a third woman came to the Mayo Clinic with the same diagnosis of valve disease and with a history of taking Pergolide for her Parkinson’s.
Dr. Abraham Lieberman, the medical director of the National Parkinson Foundation in Miami, was one of the doctors who studied Pergolide in the 1980s when it was developed. “There is evidence of pulmonary fibrosis that is associated with Pergolide,” he says, “but there’s a 14-year history of people taking Permax, and why hasn’t this showed up sooner?”
Parkinson’s disease is a progressive neurological disorder resulting from the degeneration of neurons in a region of the brain that controls movement. The degeneration creates a shortage of the brain signaling chemical known as dopamine, causing the movement impairments that characterize the disease. In the United States, at least 500,000 people are believed to suffer from Parkinson’s disease, and about 50,000 new cases are reported annually, according to the National Institute of Neurological Disorders and Stroke.

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Mark Davis, P.C. is now handling claims for individuals who have suffered a heart valve injury while taking Permax. Mark Davis, P.C. is experienced in pharmaceutical product liability cases and settlements. If you or a loved one has suffered a heart valve injury while taking Permax, contact us at 1-800-277-0300 or send us an email at info@markdavispc.com.