Patients taking weekly injectable efalizumab for psoriasis have an increased risk of serious and life-threatening infections, according to the US Food and Drug Administration (FDA). The agency announced in October that a boxed warning is being added to the product's label.
The FDA has received reports of patients treated with this drug developing bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy, and other opportunistic infections. Some patients were hospitalized and some died.
Although the drug is not approved for use in individuals younger than 18 years, the new boxed warning also will include data from studies in young mice indicating that repeated administration of the drug may cause permanent immunosuppression in younger patients.
Physicians should ensure that their patients' vaccinations are up to date prior to their receiving efalizumab and carefully monitor patients taking the drug. Patients should be instructed to report to their physician . . . [Full Text of this Article]
