On October 16, 2008, the FDA notified healthcare professionals of extensive Raptiva labeling changes, including a Black Box Warning about the risks of life-threatening infections with Raptiva use. A Black Box Warning is the FDA’s strongest health warning and means that a particular drug carries a significant risk of serious, or life-threatening, side effects.

The Raptiva Black Box Warning will highlight the risk of several different infections, including:

  • bacterial sepsis
  • viral meningitis
  • invasive fungal disease
  • progressive multifocal leukoencephalopathy (PML)
  • other opportunistic infections

In addition to the Black Box Warning, Raptiva’s

prescribing information will be updated to describe a potential risk for the permanent suppression of the immune system with repeat administration of Raptiva in children. Raptiva is not approved for children less than 18 years of age.

Reasons for Raptiva Black Box Warning

According to an FDA press release, the agency ordered the Raptiva Black Box Warning after receiving several reports of serious infections in patients using Raptiva. At least one Raptiva patient has been diagnosed with PML, a rare and usually fatal viral disease that affects the brain. Additionally, a second 62-year-old Raptiva patient developed progressive neurological symptoms and died of unknown causes.

Although there is no direct proof that Raptiva caused any of the infections outlined in the Black Box Warning, the FDA issued the Black Box Warning to make sure patients and doctors are on the lookout for potential symptoms. The FDA has advised that Raptiva patients contact a doctor at the first sign of one of the infections outlined in the Black Box Warning. Symptoms of infection may include:

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

Raptiva Side Effects Attorneys

Although the Raptiva label will now display a prominent Black Box Warning, many patients have already taken Raptiva without knowledge of Raptiva’s serious side effects. If you took Raptiva and suffered one of the serious infections now highlighted in the Black Box Warning, or any other serious side effect, you may be entitled to compensation for your injuries. Contact us today for a free and confidential case evaluation.

Published November 17, 2011 by