April 09 2009 UPDATE –Genentech, the manufacturer of the psoriasis drug Raptiva, announced that it has begun a phased withdrawal of the medication from the U.S. market. The withdrawal was initiated due to the risk of patients developing progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive neurologic disease. Raptiva will no longer be available in the United States by June 8, 2009.
Medical professionals are being asked to avoid prescribing Raptiva treatment for new patients. The Food and Drug Administration (FDA) also recommends that doctors discuss transitioning to alternative therapies with patients currently using Raptiva.
In general, PML is rare and occurs in people whose immune systems have been greatly weakened. It often leads to an irreversible decline in neurologic function and death. Right now there is no known effective treatment for PML.
Feb 24 2009 UPDATE –The Food and Drug Administration (FDA) has confirmed that three people, and possibly four, taking the psoriasis drug Raptiva have been diagnosed with progressive multifocal leukoencephalopathy (PML). Three of the patients have died and all were treated with the dangerous drug for more than three years.
PML is a potentially fatal brain infection that can also lead to severe neurological damage. The FDA has announced that it will make sure patients are clearly informed about the signs and symptoms of PML and that Raptiva's benefits outweigh its risks. Overseas, the European Medicines Agency has suggested that no new prescriptions for the drug be written and that patients talk to their doctors about alternative treatments.
Oct 20 2008 ORIGINAL ALERT – The Food and Drug Administration (FDA) has announced safety warnings and labeling changes for the psoriasis drug Raptiva. The injectable medication has been linked to severe reactions in patients, including deaths and hospitalizations.
Raptiva treats psoriasis flare-ups by suppressing the immune system. As a result, it can also increase the risk of serious infections and cancer. Therefore, Raptiva's packaging will be required to carry a boxed warning about the risks of bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy (PML), and other infections. Raptiva's label will also be updated to include data from animal studies in young mice that indicate a potential risk for permanent immune system suppression in children ages one to 14 with repeated use of Raptiva.
Earlier this month it was announced that Raptiva may have contributed to a patient getting PML, which causes swelling of the brain and is usually fatal. Additionally, Genentech Inc., which manufactures the potentially dangerous drug, said that a 70-year-old chronic plaque psoriasis patient died this month. He had been taking Raptiva for four years. The medication was approved for use in adults in 2003.