Raptiva is an immunosuppressive agent. Because immunosuppressive agents, such as Raptiva, decrease the activity of the immune system, they have the potential to increase the risk of infection. Raptiva has been associated with numerous serious, and potentially fatal, infections. These infections include:

  • cellulitis
  • pneumonia
  • abscess
  • sepsis
  • sinusitis
  • bronchitis
  • gastroenteritis
  • aseptic meningitis
  • Legionnaire’s disease
  • septic arthritis
  • vertebral osteomyelitis
  • progressive multifocal leukoencephalopathy (PML)

Raptiva Clinical Trials & Serious Infections

In the first 12 weeks of placebo-controlled Raptiva studies, the proportion of patients with serious infection was 0.4% (7/1620) in the Raptiva-treated group (5 of these were hospitalized) and 0.1% (1/715) in the placebo group. In other words, the overall rate of infection in patients taking Raptiva was 3% higher than in patients taking a placebo. Including controlled, uncontrolled, and follow-up study treatment periods, there were a total of 27 serious infections in 2,475 Raptiva patients.

Symptoms of Infection

Raptiva patients who experience symptoms of infection should contact a doctor immediately. Symptoms of infection may include:

  • fever or chills
  • sore throat
  • coughing
  • congestion
  • redness, pain, or swelling of a skin wound
  • burning or difficult urination

Raptiva Serious Infections: PML

On October 16, 2008, the FDA ordered Genentech, Raptiva’s maker, to add a black box warning to the Raptiva label about Raptiva’s association with serious infections, including progressive multifocal leukoencephalopathy (PML). Although there is no direct proof that Raptiva causes PML, at least one Raptiva patient has developed PML, and another has died after developing unexplained neurological symptoms.

Progressive multifocal leukoencephalopathy (PML), also known as progressive multifocal leukoencephalitis, is a rare and usually fatal viral infection that is characterized by progressive damage or inflammation of the brain at multiple locations. PML infection occurs almost exclusively in people with severe immune deficiency, such as patients on immunosuppressive medications (e.g. Raptiva), or AIDS patients.

Raptiva Side Effect Attorneys

If you or a loved one experienced serious side effects with Raptiva, such as serious infection or cancer, you may be entitled to compensation for your injuries. Contact us today for a free and confidential case evaluation. 

Published November 17, 2011 by