On February 19, 2009, the U.S. Food and Drug Administration (FDA) issued a public health advisory about reports of a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people using the psoriasis drug Raptiva. According to the FDA, there have been three confirmed cases and one possible case of PML in people taking Raptiva. Three of those people died.

All four Raptiva patients with confirmed or suspected PML were treated with Raptiva continuously for more than three years and ranged in age from 47 to 73 years old. None were receiving other treatments that suppress the immune system, which is notable because PML usually occurs in people whose immune systems have been severely weakened.

The FDA is reviewing the reports of PML in Raptiva users and says it will take appropriate steps to ensure that Raptiva’s risks do not outweigh its benefits, that patients prescribed Raptiva are clearly informed of PML’s signs and symptoms, and that health care professionals carefully monitor patients on Raptiva and those who have discontinued the drug for any signs of PML.

What is PML?

PML is a brain disorder caused by a virus that affects the central nervous

system. PML occurs almost exclusively in patients with severe immune deficiency, such as patients on immunosuppressive medications (e.g., Raptiva) or AIDS patients. It leads to an irreversible decline in neurologic function and often causes severe disability or death. There is no known treatment for PML.

PML Symptoms

Unfortunately, the signs and symptoms of PML can resemble many other conditions. Initially, the only signs of PML may be subtle weakness in the hands or legs, difficulty thinking or concentrating, and/or a lack of coordination. Other PML symptoms may include:

  • changes in vision
  • difficulty speaking
  • personality changes
  • headache
  • seizure

Raptiva PML Attorney

If you or a loved one has taken Raptiva and experienced serious side effects, such as PML or another type of infection, you may be entitled to compensation for your injuries. Contact our experienced Raptiva side effect attorneys today for a free and confidential case evaluation.

Published November 17, 2011 by