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On February 24, 2003, Eli Lilly and Company of Indianapolis informed healthcare professionals that the professional product labeling, or “package insert,” for pergolide (PERMAX) was being updated to include a warning about the possibility of heart valve damage with the drug. Pergolide, first marketed in the U.S. in 1989, is approved by the Food and Drug Administration (FDA) to be used in combination with levodopa and carbidopa (SINEMET) in the management of the signs and symptoms of...
On February 24, 2003, Eli Lilly and Company of Indianapolis informed healthcare professionals that the professional product labeling, or “package insert,” for pergolide (PERMAX) was being updated to include a warning about the possibility of heart valve damage with the drug. Pergolide, first marketed in the U.S. in 1989, is approved by the Food and Drug Administration (FDA) to be used in combination with levodopa and carbidopa (SINEMET) in the management of the signs and symptoms of Parkinson’s disease.
Pergolide is a derivative of a natural product known as ergot. The damage to heart valves with pergolide is similar to that seen with the use of other ergot products, in a condition known as carcinoid syndrome, which is a tumor that secretes the chemical messenger serotonin, and with the use of the dangerous diet drugs fenfluramine (PONDIMIN), dexfenfluramine (REDUX) and phentermine (FASTIN, IONAMIN). Fenfluramine and dexfenfluramine were removed from the market in September 1997 because of heart valve damage and other adverse reactions. Phentermine, unfortunately, remains on the market.
The Warnings section of the professional product labeling for pergolide will be modified to describe reports of inflammation of the lining around the lungs (pleuritis), fluid accumulation around the lungs (pleural effusion), formation of fibrous tissue around the lungs (pleural fibrosis), inflammation of the lining around the heart (pericarditis), accumulation of fluid around the heart (pericardial effusion), heart valve damage (valvulopathy) and the formation of fibrous tissue in the abdomen (retroperitoneal fibrosis). The text of this section now reads:
Serous Inflammation and Fibrosis — There have been rare reports of pleuritis, pleural effusion, pleural fibrosis, pericarditis, pericardial effusion, cardiac valvulopathy involving one or more valves, or retroperitoneal fibrosis in patients taking pergolide. In some cases, symptoms or manifestations of cardiac valvulopathy improved after discontinuation of pergolide. Pergolide should be used with caution in patients with a history of these conditions, particularly those patients who experienced the events while taking ergot derivatives. Patients with a history of such events should be carefully monitored clinically and with appropriate radiographic and laboratory studies while taking pergolide.
The medical journal Mayo Clinic Proceedings published three case reports in December 2002 of patients who were diagnosed as having heart damage while receiving long-term pergolide treatment.
The first patient was a 72-year-old woman with a seven-month history of severe lower extremity edema (fluid retention), a 20-pound weight gain and a new heart murmur. A heart murmur may be a sign of heart valve damage. She had been taking pergolide in addition to levodopa with carbidopa for a period of four years before her problems developed.
She required a heart valve replacement. The appearance of her old valve was similar to those seen with the damage caused by ergot products, carcinoid syndrome and the diet drugs.
The second patient was a 74-year-old woman with a two-year history of shortness of breath, difficulty in breathing when lying down and fluid retention in the feet and ankles. She had been using pergolide for three years to treat restless legs syndrome, a use that is not approved by the FDA.
Restless legs syndrome consists of bothersome, but usually not painful, sensations deep in the legs that produce an irresistible urge to move. These sensations are sometimes described by patients as creeping, itching, pulling, creepy-crawly or tugging. Restless legs syndrome is not a form of Parkinson’s disease.
This patient required the replacement of three heart valves.
The final patient described in the Mayo Clinic article was a 61-year-old woman with a history of a heart murmur of several years’ duration. Tests identified problems with the heart valves. She had been treated for Parkinson’s disease with levodopa and carbidopa plus pergolide for seven years. She had none of the symptoms of severe heart problems that were seen in the second patient.
The pergolide was stopped. Additional tests were repeated after three months but no improvement was found in her heart valves.
What You Can Do
If you are now taking pergolide, you should discuss with your physician checking for a new or worsening heart murmur and, if one is found, undergoing a thorough heart examination.
