Recall for Raptiva Finalized Due to Brain Infection Risk

The complete recall of the psoriasis drug Raptiva throughout the United States and participating countries of the European Union will be finalized this week, after sales were suspended earlier this year due to the risk of serious Raptiva side effects, including a fatal brain infection known as progressive multifocal leukoencephalopathy (PML).

When sales of the drug were suspended in April 2009, it was announced that a phased recall of Raptiva would be done to allow doctors time to gradually switch patients to alternative treatments. When the action was announced by the FDA, they indicated that the drug would no longer be available in the United States by June 8, 2009.

This week, the European Medicines Agency (EMEA) announced that a final Raptiva recall for all remaining batches of the drug will be issued in the next few days, which will make it no longer available anywhere in the European Union (EU) as well.

“All patients who were treated with Raptiva before the suspension should now have been switched to alternative treatments,” according to an EMEA press release issued on June 8. “The Agency has been working closely with the company to organize the complete recall of all remaining batches of Raptiva in the EU, in accordance with the process agreed in each individual Member State.”

Raptiva (efalizumab) was a once-weekly injection used to treat psoriasis. In October 2008, Genentech added a “black box” warning to the medication in the United States indicating that infection side effects of Raptiva could increase the risk of viral meningitis, invasive fungal disease, bacterial sepsis, the rare brain disease PML and other opportunistic infections.

A decision was made to pull the drug from the market about six months later, after it was linked to three confirmed and one suspected case of progressive multifocal leukoencephalopathy (PML). The brain infection attacks the central nervous system and is often fatal. Symptoms can include weakness, paralysis, vision loss, impaired speech, cognitive deterioration and death.

At the time of the Raptiva recall, the drug was only being used by about 2,000 people in the Untied States and it had only been used by 46,000 people worldwide since it was first introduced in 2003.

Several Raptiva recall lawsuits have already been filed in California state court on behalf of individuals who allege that they suffered serious brain infections and related injuries.