The agency today made a big point of announcing the “voluntary withdrawal” of Permax, a drug used to treat Parkinson’s disease, along with generics known collectively as pergolide.

The move comes after mounting reports of heart-valve problems, which resulted last year in a Black Box warning and were confirmed more recently in studies in The New England Journal of Medicine. The FDA requested the so-called voluntary withdrawal by Valeant Pharmaceuticals, as well as Par Pharmaceuticals and Teva Pharmaceuticals, which sell generic versions.

An agency official touted this as a prime example of safety monitoring. “The FDA’s increased evaluation of post-market safety is benefiting the public because, in this case, as new data about the product became available, we were able to remove a less safe drug from the market,” says Doug Throckmorton, deputy director of the Center for Drug Evaluation and Research.

Maybe so. But only an estimated 12,000 patients were prescribed this drug last year. If the FDA really wants to get tough on safety, the new commish, Andy von Eschenbach, will let his medical reviewers scour the data on any widely used med that may turn out to sport a red flag. Taking Permax off the market is a good move, but an easy choice.

Further reading…
FDA statement;
TheStreet.com.[tags]FDA, Par Pharmaceuticals, Teva Pharmaceuticals, Valeant Pharmaceuticals[/tags]