Raptiva Recall in Canada and Europe Due to Risk of PML Brain Infection

Following recommendations that a Raptiva recall be issued due to a potential risk of users developing a deadly brain infection, sales of the psoriasis drug are being suspended in Canada and Europe. In the United States, the FDA is continuing to review whether the benefits of Raptiva outweigh the risks, and have urged doctors to carefully monitor any patients receiving the treatment.

Raptiva (efalizumab) is a subcutaneous injection administered once a week, which blocks the activation, reactivation and trafficking of the T-cells that cause psoriasis.

Last week, the FDA notified healthcare providers that they had become aware of one possible and three confirmed cases of a rare brain disease known as progressive multifocal leukoencephalopathy, which may have been caused by side effects of Raptiva. All four of the individuals were using Raptiva for more than three years and none were taking any other treatments that suppress the immune system.

Progressive multifocal leukoencephalopathy, also known as PML, is a deadly brain infection which attacks the central nervous system, damaging the white matter of the brain at several locations. There is no known cure for the disease, and it can present with symptoms like weakness, paralysis, vision loss, impaired speech, cognitive deterioration or death.

Following the emergence of information about the potential Raptiva PML side effects, Health Canada and the European Medicines Agency (EMEA) recommended that a Raptiva recall be issued and that sales be suspended.

On Friday, February 20, 2009, the European Medicines Agency (EMEA) formally suspended sales of Raptiva, which was marketed by Genentech/Merck KGaA in the European Union. The Raptiva recall was announced after the EMEA indicated to the European Commission that the risk of developing the deadly PML brain infection outweighed the benefits provided by the drug.

In Canada, Serono Canada, Inc., the affiliate of Merck Serono that markets Raptiva in Canada, announced on Monday that they were suspending sales of the drug in Canada based on a similar recommendation by Health Canada. Doctors were advised not to write any new prescriptions for Raptiva and to discuss alternatives with patients who are already on the drug as soon as possible. Within a few months, Raptiva will no longer be available in Canada.

In the United States, the FDA indicated last week that they are continuing to review the latest information about the potential PML brain infection side effects of Raptiva to determine what regulatory actions should be taken. A “black box” warning, which is the strongest warning that can be placed on a prescription drug, was added to Raptiva in October 2008, and they are attempting to determine what, if any, additional regulatory action should be taken.

While the FDA is determining whether the reported cases of progressive multifocal leukoencephalopathy tip the risk/benefit balance in favor of a Raptiva recall, doctors have been urged to carefully monitor any patients who are given the drug and to make sure that patients are clearly informed of the symptoms of the Raptiva brain infection.