Serious Infections and Neurological Events with Raptiva

FDA is highlighting the risk of life-threatening infections in patients treated with Raptiva (efalizumab). Raptiva is an immunosuppressant approved as a once a week injection to treat certain adult patients with moderate to severe plaque psoriasis.

FDA has received reports of serious infections in patients treated with Raptiva, in some cases leading to hospitalization and even death. A new boxed warning will highlight the risk of bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy (PML) and other opportunistic infections.

Raptiva's label will also be updated to include data from studies of juvenile mice. These data suggest that repeated administration of Raptiva to pediatric patients may lead to permanent suppression of the immune system. Raptiva is not approved for children under 18 years of age.

Prescribers should carefully evaluate the risk/benefit profile of Raptiva for patients who may be more susceptible to these risks. Before starting Raptiva, make sure patients are up-to-date on their vaccinations. During therapy, do not vaccinate patients with live or live attenuated vaccines. Also, giving inactivated vaccines during Raptiva treatment may not produce an adequate immune response.

Patients should be taught to recognize the signs and symptoms of serious infections, as well as neurological disorders, anemia, thrombocytopenia, or the worsening of their psoriasis. If any of these signs appear, they should be told to seek immediate medical attention.

FDA is requiring Raptiva's manufacturer to submit a Risk Evaluation and Mitigation Strategy (REMS) which will include a medication guide for patients.

FDA Patient Safety News: Jan/Feb 2009

For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=83#1

Category:

Education

Tags:

• Psoriasis
• Raptiva
• infection
• bacterial sepsis
• PML
• side effect
• adverse event
• FDA