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FDA Video: Serious Infections and Neurological Events with Raptiva

In February 2009, the U.S. Food & Drug Administration (FDA) issued the video below warning of the risk of life-threatening infections in patients treated with Raptiva (efalizumab).

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.

Do I Have a Raptiva (efalizumab) Lawsuit?

The Defective Drugs & Products Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Raptiva lawsuits. We are pursuing individual litigation nationwide and currently accepting new Raptiva induced Progressive Multifocal Leukoencephalopathy, PML and/or brain infection cases in all 50 states.

If you or a loved one have used Raptiva (efalizumab) and developed progressive multifocal leukoencephalopathy (PML), you should contact us immediately. You may be entitled to compensation for your injuries or unfortunate loss and we can help.

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