Legal Specs

Permax Recall

30 Apr 2007

Following two recent studies, the Federal Drug Administration (FDA) announced a Permax recall on March 29, 2007. The Permax recall includes both the name brand Permax (peroglide) and the generic versions of peroglide. Current studies have revealed Permax heart valve disease in around one-fourth of Parkinson's patients who have taken Permax over an extended period of time.

Permax Valvulopathy (valve injuries) first came to the attention of the Federal Drug Administration (FDA) in 2002. Permax was approved by the FDA in 1988. Prior to the Permax recall, the FDA added a black box warning regarding the risk of serious heart valve damage.

Permax side effects including heart valve damage were revealed in the studies published in the New England Journal of Medicine (NEJM). High rates of valve leakage were found in up to 20% of patients prescribed Permax. Dr. Robert Temple, the associate director for medical policy at the Center for Drug Evaluation and Research, stated that Permax (Peroglide) was linked with a fivefold increase in regurgitation of the mitral, atrial, or tricuspid valves compared with the general population. The side effects revealed in these studies were further evidence of the ongoing problems leading to the Permax recall.

Permax, which is also known as Peroglide, is used in the treatment of Parkinson's patients and also for a condition called Restless Legs Syndrome (RLS). Parkinson's disease is caused by the degeneration of neurons in an area of the brain involved with movement control that results in a progressive neurological disorder. Restless legs syndrome is also a neurological condition, however it is often misdiagnosed even though it affects around 2.7% of people in the United States. Permax heart valve damage has been reported in both Parkinson's and Restless Legs Syndrome patients around the United States. The Permax recall is expected to affect the future treatment of both Parkinson's and RLS patients.

Permax was released in 1989 after being developed by Eli Lilly. Over 500,000 people have taken Permax since 1989 to treat Parkinson's and RLS. Two European studies were conducted in Britain and Italy. In the Italian study, of the 155 people who had taken Permax, 23.4% of them developed Permax heart problems. The British study involved 11,417 people who were taking the drug. Patients in the British study were 37 times more probable to develop Permax heart damage problems. Serious Permax heart valve disease has also been reported by the Mayo Clinic in patients who took the drug and were later diagnosed with heart problems.

The FDA has announced that due to the Permax recall patients with Parkinson's should:
• Contact their healthcare professional to discuss alternate treatment options.
• NOT stop taking Peroglide (Permax) without consulting their healthcare professional, since stopping Permax can be dangerous and several other effective treatments are available.

The FDA has stated that the effect of the Permax recall will not be immediate. There will be a delay which will allow doctors and patients to arrange for appropriate replacement treatment options. Following the Permax recall, the companies that manufacture and distribute peroglide (Permax) are cooperating with the FDA in the removal of the drug from the marketplace.


Steve Fields
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