Prior to its recall in March 2007, Permax carried a black box warning, the strongest required by the FDA. The warning addressed the increased risk of heart valve problems in patients.
Permax originally was made by Eli Lilly, but rights to the manufacture and distribution of the drug were transferred to Valeant Pharmaceuticals.
Dostinex does not include a black box warning and lists heart valve problems as only a "precaution." Dostinex was developed by Pfizer.
Dr. Bryan Roth of the University of North Carolina School of Medicine called the risk of heart valve disease "extraordinarily high" and recommended against prescribing the drugs. Dr. Michael Okun, the medical director of the National Parkinson Foundation, observed that there are safer, equally effective drugs available to Parkinson's patients.
These serious side effects associated with Permax and Dostinex are the same problems that led to the withdrawal of the drug combination Fen-Phen. |