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Safety Concerns and Labeling Changes for Psoriasis Drug Raptiva

The Food and Drug Administration (FDA) has announced labeling changes, including a boxed warning, to highlight the risks of life-threatening infections with the use of Raptiva (efalizumab). FDA is also requiring the drug’s manufacturer to submit a Risk Evaluation and Mitigation Strategy (REMS), which will include a Medication Guide for patients and a timetable for assessment of the REMS.

Psoriasis is an inflammatory skin disease. Raptiva is a once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for systemic (whole body) therapy or phototherapy (treatment with light) to control their psoriasis.

Raptiva was approved in 2003. It is manufactured by Genentech Inc. of San Francisco, Calif.

Serious Infections

FDA has received reports of serious infections leading to hospitalizations, and deaths in some cases, in people who use Raptiva.

The now-required boxed warning will highlight the risk of bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy (PML), and other infections. PML is a rare but life-threatening disorder that affects the central nervous system.

Additionally, Raptiva's label will be updated to include data from animal studies in young mice (equivalent in age to a 1-14 year-old human) that indicate a potential risk for permanently suppressing the immune system with repeated use of Raptiva in this age group. Raptiva is not approved for children under 18 years of age.

Raptiva works by suppressing the immune system to reduce flare-ups of psoriasis. However, by suppressing the body's natural defense system, it can also increase the risk of serious infections and cancer.

Recommendations for Using Raptiva

• Talk with your health care professional before beginning treatment with Raptiva if you have a pre-existing infection or a compromised immune system.
• Get all age-appropriate vaccinations before starting treatment with Raptiva. Do not get vaccinations while you are using Raptiva.
• Learn to recognize the signs and symptoms of PML (confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems), anemia (dizziness upon standing, weakness or jaundice), thrombocytopenia (bruising, bleeding gums, pinpoint-sized red or purple dots under the skin), infection, or worsening of psoriasis or arthritis.
• Learn to recognize the signs of a nervous system disorder, including the sudden start of numbness, tingling, or weakness in the arms, legs, or face.
• Report immediately any of these signs and symptoms to your health care professional.
• You may also report adverse events to FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at www.fda.gov/medwatch/report.htm.

This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

For More Information

FDA Press Release
www.fda.gov/bbs/topics/NEWS/2008/NEW01905.html

Date Posted: October 20, 2008

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