FDA Updates Raptiva Box Warning Label to "Serious Infection Risk"

In October 2008, the Food and Drug Administration announced labeling changes, including a Boxed Warning for the psoriasis drug Raptiva.

The now-required Raptiva Boxed Warning will highlight the risk of bacterial sepsis, viral meningitis, invasive fungal disease, PML (progressive multifocal leukoencephalopathy), and other opportunistic infections.

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

The Boxed Warning labeling changes are based on the FDA's post-market surveillance. The FDA is also requiring the submission of a Risk Evaluation and Mitigation Strategy (REMS), which will include a Medication Guide for patients and a timetable for assessment of the REMS.

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The monitoring arm of the FDA has received reports of serious infections leading to hospitalizations and deaths for patients using Raptiva. The FDA received reports of serious infections in some patients taking Raptiva. These reports led to their decision to highlight the risks in the drugs labeling. Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to these risks.

The updated label also includes a warning about certain neurologic events as well as precautions regarding immunizations and pediatric use. A Dear Healthcare Provider letter was issued to communicate this updated prescribing information to healthcare professionals.

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Raptiva's label will be updated to include data from juvenile animal studies in mice indicating a potential risk for the permanent suppression of the immune system with repeat administration of Raptiva. The psoriasis drug is not approved for children younger than 18 years of age.

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