After two recent studies, the Federal Drug Administration [FDA] announced a Permax recall on March 29, 2007. Permax recalls include both the Permax [peroglide] brand name and the generic version of peroglide. Current research reveals Permax heart valve disease in about a quarter of Parkinson's disease patients who have been taking Permax for an extended period of time.
Permax Valvulopathy was first noticed in 2002 by the Federal Drug Administration [FDA]. Permax was approved by the FDA in 1988. Damaged valve.
Permax side effects, including heart valve injury, were revealed in a study published in the New England Journal of Medicine [NEJM]. High valve leak rates were found in up to 20% of patients prescribed Permax. Dr. Robert Temple, Deputy Director of Medical Policy at the Center for Drug Evaluation and Research, said that Permax [Peroglide] had a five-fold increase in mitral, atrial, or tricuspid regurgitation compared to the general population. Said that it is related. The side effects revealed in these studies were further evidence of ongoing problems leading to Permax recall.
Permax, also known as Peroglide, is used to treat patients with Parkinson's disease and is also used in a condition called Restless Leg Syndrome [RLS]. Parkinson's disease is caused by neuronal degeneration in areas of the brain that are involved in motor control that causes progressive neuropathy. Restless legs syndrome is also a neurological symptom, but it is often misdiagnosed despite affecting about 2.7% of people in the United States. Permax heart valve injury has been reported in both Parkinson and restless legs syndrome patients throughout the United States. Permax recalls are expected to affect future treatment for both Parkinson's and RLS patients.
Permax was developed in 1989 after being developed by Eli Lilly. Over 500,000 people have taken Permax since 1989 for the treatment of Parkinson's disease and RLS. Two European studies were conducted in the UK and Italy. In an Italian study, out of 155 people who took Permax, 23.4% developed Permax heart disease. The UK study involved 11,417 people who were taking drugs. Patients in the UK study were 37 times more likely to develop Permax heart problems. Severe permax heart valve disease has also been reported at the Mayo Clinic of patients who have taken drugs and were later diagnosed with heart problems.
The FDA has announced that Parkinson's disease patients should:
o Contact a health care professional to discuss alternative treatment options.
o Do not stop taking Peroglide [Permax] without consulting your healthcare professional because stopping Permax can be dangerous and there are several other effective treatments.
The FDA states that the effect of the Permax recall does not appear immediately. There is a delay that will allow doctors and patients to arrange appropriate alternative treatment options. Following the Permax recall, companies that manufacture and sell peroglide [Permax] are working with the FDA in removing drugs from the market.