Raptiva Pulled from Market Due to Concerns About Side Effects

San Antonio, TXIt has been more than three years since Raptiva was voluntarily withdrawn from the market due to concerns about serious Raptiva side effects. Specifically, the drug was pulled after reports surfaced of a reported increased risk of Raptiva PML (progressive multifocal leukoencephalopathy), a rare progressive neurologic disease that is often fatal. Even though Raptiva was pulled from the market three years ago, lawsuits were scheduled to go to court in 2012.

On February 19, 2009, the US Food and Drug Administration (FDA) issued an alert that it received four reports of PML either fully or potentially linked to the use of Raptiva. Of those four incidents, three patients died. All four of the patients had taken Raptiva for more than three years and none of the patients took any other medications that could suppress the immune system. Just two months after the FDA's alert was issued, Genentech, manufacturer of Raptiva, voluntarily withdrew it from the market.

According to Bloomberg (1/13/12), approximately 100 Raptiva lawsuits were consolidated in state court in Oakland, CA as of January 13, 2012. More lawsuits were reportedly pending in Texas and Massachusetts, alleging Genentech??"which was bought by Roche Holdings AG one month before Raptiva was recalled??"downplayed the risks associated with Raptiva.

At least one Raptiva lawsuit was scheduled for court in 2012. That lawsuit was filed by the family of Stephen Johnson and alleges the businessman died of PML after taking Raptiva for approximately five years to treat psoriasis, Bloomberg (1/26/12) reports. The family sought $15 million in compensatory damages.

In January 2012 the plaintiff's legal team announced they had reached a settlement in the lawsuit, which Roche denied. The plaintiff's team later retracted the statement and the lawsuit, which was set for court January 30, 2012, was then delayed until June 4, 2012.

Progressive multifocal leukoencephalopathy is a rare brain infection that attacks the patient's central nervous system. When the FDA announced the voluntary recall of Raptiva, it noted that the risk of developing PML was rare and associated with long-term use. "Generally, PML occurs in people whose immune systems have been severely weakened and often leads to an irreversible decline in neurologic function and death," the FDA stated. "There is no known effective treatment for PML," (4/8/09). Symptoms include weakness, impaired speech, vision loss and cognitive deterioration. When it was on the market, Raptiva was given as a once-weekly shot to treat psoriasis, an inflammation of the skin.

The lawsuit is Johnson v. Genentech Inc., RG 10-494957.