Genentech Inc. announced that it is withdrawing its psoriasis drug, Raptiva, after the U.S. Food & Drug Administration (FDA) linked the drug to a rare, but often fatal brain infection.
Dangerous drug
Genentech, which was purchased by Roche Holding AG, last month, has pulled its psoriasis drug Raptiva off of the U.S. market after European drug regulators recently pulled the drug from their market. According to news reports, the European Medicines Agency (EMA) and the FDA said that they have received three confirmed and one possible report of Progressive Multifocal Leukoencephalopathy (PML) in patients taking Raptiva.
PML, which attacks and weakens the white matter surrounding brain cells, has also been linked to the multiple sclerosis drug Tysabri which is manufactured by Biogen Idec Inc. and Elan Corp. The drug’s prescribing information was updated to include a boxed warning on the risk of serious infections, including PML, in October of 2008. The warning was updated again about a month ago to provide additional information on the risk of PML and to provide a new medication guide for patients taking the drug.
Patients advised to see doctor
Patients taking Raptiva are being advised to talk with their doctors to discuss alternatives to the drug, which will not be available after June 8th, 2009. Patients who stop taking the drug are at a higher risk of their psoriasis becoming worse.
Raptiva's prescribing information was updated in October to include a boxed warning on the risk of serious infections, including PML. Last month, it was updated again to include additional information on the risk of PML and a new medication guide for patients.