The manufacturer, Valeant Pharmaceuticals International, agreed to discontinue wholesale distribution of Permax after reports from FDA that it can damage mitral, atrial, or tricuspid valves of heart by causing them to leak.
According to Dr. Robert Temple, an officer from the FDA's office of drug evaluation, an estimated 12,000 to 25,000 patients in U.S. have Parkinson's disease. It is a degenerative disorder of the central nervous system that often impairs the sufferer's motor skills and speech.
Parkinson's disease belongs to a group of conditions called movement disorders. It is characterized by muscle rigidity, tremor, a slowing of physical movement (bradykinesia), and in extreme cases, a loss of physical movement (akinesia).
The FDA has earlier warned Valeant Pharmaceuticals International about the link between pergolide and valve disease since 2002 and it also added a warning about it to the drug's label. In 2006, the warning was upgraded to a black box because of new data concerning risks of heart valve damage.
The agency now cautions that people taking Permax should not stop the intake of the drug abruptly but should slowly reduce the dosage in the guidance of their doctor. FDA has also urged the company not to discontinue pharmacy sales so that patients can continue to use the drug until some alternate is found.
So far at least 14 patients have undergone heart valves replacement. Permax acts by stimulating the brain's production of the neurotransmitter dopamine and is given in combination with other drugs, such as levodopoa.
