Health
FDA issues new warning about psoriasis drug
NEWS IN BRIEF — Posted Nov. 10, 2008
The Food and Drug Administration has heightened the warnings on the psoriasis drug, Raptiva (efalizumab), to include a black box highlighting the risk of life-threatening infections. The agency announced the change Oct. 20.
The FDA is also requiring the manufacturer to submit a risk evaluation and mitigation strategy which is to include a medication guide for patients.
Raptiva is a once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy to treat their disease.
The boxed warning will note the risk of bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other infections.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2008/11/10/hlbf1110.htm.
