Raptiva Infection Side Effects Lead to Recall in U.S.

Genentech, Inc. has issued a Raptiva recall in the United States as a result of side effects which could cause a rare, but often fatal, brain infection that attacks the central nervous system, known as progressive multifocal leukoencephalopathy (PML).

Raptiva (efalizumab) is a once-weekly injection that is used to treat psoriasis.

Earlier this year, four cases of PML brain infections were linked to Raptiva side effects, leading to the addition of a “black box” warning in the United States. Genentech was also required to distribute a medication guide with all prescriptions to inform users of the potentially fatal risk.

In February 2009, a recall of Raptiva was issued in Canada and Europe due to the risk of PML infection, and the FDA indicated at that time that they were continuing to review the latest information to determine whether additional regulatory actions should be taken in the United States.

PML brain infections damage the white matter of the brain at several locations, producing symptoms like weakness, paralysis, vision loss, impaired speech and cognitive deterioration. There is no known cure or treatment for the disease, and it usually results in death.

According to a statement released by the FDA, Genentech decided to voluntarily remove Raptiva from the U.S market because of the risk that users may develop progressive multifocal leukoencephalopathy brain infections.

“Although we believe that many psoriasis patients are benefiting from Raptiva, the balance between benefit and risk in the psoriasis population for which Raptiva was approved has significantly changed,” said Genentech’s senior vice president, development, and chief medical officer, Hal Barron, in a statement released April 8, 2009.

The Raptiva recall will occur in phases over the next several months. Doctors are being asked not to start any patients on the drug, as it will no longer be available in the United States by June 8, 2009.

Raptiva, which has been on the market for five years, generated sales of $108 million in 2008. At the time of the recall, Raptiva was being used by about 2,000 people in the United States, and more than 46,000 people worldwide have used the drug to treat psoriasis since it was introduced.