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FDA officials have received three confirmed reports, and a forth possible report, of dangerous brain infections in patients treated with Genentech's psoriasis drug Raptiva. With three of these four already dead, the FDA has issued an updated safety advisory for Raptiva and is reviewing the latest information.

According to the FDA's updated safety release, the FDA approved Raptiva in 2003. What has regulators concerned now is the link between Raptiva and a deadly type of brain condition called progressive multifocal leukoencephalopathy (PML). As described by the FDA, PML is a "rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system." It occurs usually in people with severely weakened immune systems and often causes irreversible decline in brain function and death. It has no known effective treatment.

In October, the FDA added a black box warning, its highest level of warning, for Raptiva over the risk of PML. "It appears increasingly likely that the FDA will ultimately pull Raptiva from the market," industry analyst Geoff Porges told Bloomberg.

Raptiva also faces likely removal from European markets. As the Wall Street Journal reports, today Europe's primary medical regulator urged the suspension of sales of Raptiva. Bloomberg quotes an email from one European regulator as saying that "prescribers should not issue any new prescriptions for Raptiva and should review the treatment of patients currently receiving the medicine to assess the most appropriate alternatives."

Here, regulators advise that patients using Raptiva should:

• Talk with their healthcare provider about the benefits and risks of treatment with Raptiva;
• Be aware of the symptoms of PML which may include unusual weakness, loss of coordination, changes in vision, difficulty speaking and sometimes personality changes;
• Contact their healthcare provider immediately if they experience these symptoms; and
• Understand that there are no laboratory screening tests for PML or medical interventions that can prevent or treat PML.

The FDA states that it is analyzing the latest information on PML in patients taking Raptiva and promises to "take appropriate steps to ensure that the risks of Raptiva do not outweigh its benefits."

• FDA Updated Safety Information about Raptiva
• FDA October 2008 Press Release re Black Box Warning
• When to Use Boxed Warnings (FDA)
• Genentech's Raptiva Faces EU Suspension on Infections (Bloomberg)
• Psoriasis Drug Withdrawn over Brain Disease Fears (Irish Times)
• Medical Product and Device Defects (FindLaw)