Personal Injury Law

Psoriasis Drug Linked To Deaths

By Jane Akre

The Food and Drug Administration (FDA) has issued a public health advisory about the immunosuppressant drug, efalizumab (Raptiva) made by Genentech, Inc. 

Three deaths from progressive multifocal leukoencephalopathy (PML) have been reported. A fourth case is being looked at as well.  The patients ranged in age from 47 to 73 years of age.

All of the patients had been on efalizumab for at least three years and that was the only immunosuppressant drug they had taken.

PML is a rare but serious progressive neurologic disorder caused by a virus that attacks the central nervous system.  Patients with a severely compromised immune system are its most likely victims suffering from an irreversible brain function and death.   No treatment exists for PML.

The drug received a black box warning last October which included the risk for infection that could be life-threatening. 

Raptiva is used to treat adults with moderate to severe plaque psoriasis.  Efalizumab is an anti-CD11a antibody immunosuppressant. It works by affecting T-cells of the immune system and decreases function of the immune system, therefore increasing susceptibility to infections. 

It was approved in October 2003. At the time no cases of PML were reported in clinical trials.

The FDA says doctors should monitor patients closely to evaluate whether treatment should continue.  Patients and their doctors can report adverse events to the FDA's MedWatch program at 1-800-FDA-1088 or by going online. #

Full post as published by InjuryBoard on February 20, 2009 (boomark / email).