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Efalizumab label changes address safety issues


The risk of serious infections has led the US Food and Drug Administration (FDA) to alter the labelling for efalizumab (Raptiva[R]), an injectable treatment approved for moderate to severe plaque psoriasis patients who are candidates for systemic therapy or phototherapy. Reports of infections which led to hospitalizations and deaths were received by the agency, and a boxed warning will now include information of the risks of bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections. The frequency of these adverse events and their relationship to the treatment are not known. Efalizumab is not approved for patients aged under 18, but the revised labelling will also include information ...

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