The Raptiva Recall

The recall decision followed two FDA warnings that the drug might be linked to progressive multifocal leukoencephalopathy (PML), a deadly neurological disorder that occurs in people with suppressed immune systems.

Since October 2008, the FDA and Genentech have made the public aware of three confirmed cases of PML and one potential case of PML that were linked to long-term use of Raptiva. Raptiva is a drug that works by suppressing the T-cells, which if unsuppressed can create symptoms in psoriasis patients.

The three confirmed cases were all in patients who had been taking the drug for more than three years. All three patients died from PML. Genentech is unable to say with certainty how long a patient must be taking Raptiva in order for the patient to be at risk of developing PML. That uncertainty, combined with the almost certain fatality or permanent and significant disabilities associated with the untreatable condition of PML, have lead Genentech to issue the Raptiva recall.

While the risk of developing PML might not seem great, PML is so dangerous and the incidence of fatalities is so high that Genentech decided to issue a voluntarily Raptiva recall. The drug will no longer be available in the United States as of June 8, 2009.

What Patients Taking Raptiva Should Do

It is important for psoriasis patients who are currently taking Raptiva or who have taken the drug in the past to take the following steps. First, anyone who is taking or who has taken Raptiva should be familiar with the new medication guide that was approved by the FDA on March 13, 2009. The first few sentences of the medication guide read as follows:

RAPTIVA increases the risk for PML, a rapidly progressive viral infection of the central nervous system that has no known treatment and that leads to death or severe disability. The risk of PML may markedly increase with longer duration of RAPTIVA exposure. The time dependent threshold when the risk for PML increases is unknown.

Pages 7-8 of the medication guide explain that Raptiva users should be regularly screened by their physicians for new neurological symptoms and should promptly report any change in neurological symptoms to their doctors. Those symptoms include, but are not limited to, confusion, clumsiness, memory loss, confusion or personality changes. Anyone who is taking Raptiva or who has taken Raptiva in the past should be aware that these neurological changes can be symptoms of PML.

Second, every patient who is still taking Raptiva should immediately consult his or her prescribing physician. Raptiva should not be stopped without your physician's knowledge and specific instructions because a sudden end to the medication can cause a serious flare-up of psoriasis symptoms that could result in a hospitalization.

In order to prevent that, patients should speak with their doctors about alternative treatments that they can use.

In Genentech's April 8, 2009 letter to health care professionals, the company admits that the balance between the benefit Raptiva provides to psoriasis patients and the risks associated with the drug have "significantly changed" since the drug was approved in 2003. It reminds doctors that it is impossible to tell which patients are at greater risk for developing PML and that there is no effective treatment for PML.

Finally, patients who took Raptiva and suffered from PML or other neurological disorders, or their surviving family members, should contact a Raptiva lawyer who can advise them of their rights in this difficult situation.