Personal Injury Law

Raptiva linked to deadly rare Brain Infection

By Brian F. LaBovick, Esq.

According to the FDA users of the psoriasis medication Raptiva (efalizumab), have a new issue to think about. Recently, the FDA issued a public health advisory regarding an increased risk factor for Raptiva patients to develop a rare brain infection, known as Progressive Multifocal Leukoencephalopathy (PML).  According to the FDA, PML is caused by a virus that affects the central nervous system. This brain infection occurs almost exclusively in patients on immunosuppressive medication. Symptoms include: unusual weakness, loss of coordination, changes in vision, difficulty speaking and personality changes. The FDA stated that possibly four known victims contracted this infection while on the medication Raptiva for over three years.  None of the victims were on immunosuppressive medication. Presently, there is no known effective cure or treatment for PML. 

Raptiva, marketed in the U.S. by San Francisco Pharma manufacturer, Genentech, is a once-weekly injection approved for adults with moderate to severe plaque psoriasis.  Approved by the FDA in 2003, the drug showed no cases of PML in clinical trials. Reports indicate that nearly 3,000 patients were treated with the drug during the clinical trials. The medication was administered to 218 people for one year or more, over 900 patients for six months and 2,400 patients for three months. Approximately 46,000 people worldwide have been treated with Raptiva, since 2003.

Late last year, the FDA, approved a Black Box warning label change of the drug Raptiva in October 2008. The new FDA Box warning stated that using Raptiva could increase the risk for infection. Genentech manufacturer of Raptiva, has been ordered by the FDA, to investigate the effects and likelihood of PML being contracted while taking Raptiva.

Since the FDA's recent advisory, Genentech has taken steps to notify users and medical professionals about the risks of taking Raptiva, by outlining specific risks on the website and sending warning letters to patients and health care providers. Unfortunately, all of this is a little too late for the victims that died, possibly due to using Raptiva for treatment of  psoriasis. According to reports, they were using Raptiva for at least three years.

The FDA has vowed to 'take appropriate steps' to ensure that the treatment benefits of Raptiva outweigh the heightened potential risk of contracting PML. Further, the FDA is informing health care providers what to look for in PML cases. They have issued a warning to physicians that they may see more cases of PML. In addition, they  are directly informing Raptiva patients of the risks involved with using the psoriasis medication and describing the symptoms of PML. Hopefully, these proactive measures will help prevent more deaths. 

 

Full post as published by LaBovick Injury Law Blog on March 19, 2009 (boomark / email).