FDA Safety Review Recommends Updated Labeling for TNF Inhibitors
August 5, 2009
The U.S. Food and Drug Administration released revised requirements for the updating of the prescribing information for all currently licensed TNF inhibitors (etanercept, infliximab, adalimumab, golimumab, and certolizumab). Based on a recent review of post-marketing safety data, the agency is mandating that prescribers be aware of an increased event rate for malignancies in children and adolescents receiving this class of medications. Cases of leukemia in adults receiving TNF inhibitors and new onset psoriasis in users were also the subject of additions to prescribing requirements. A link to the summary of the requirements, designated as “for Healthcare Professionals” (including a summary of the data from which the requirements were based) can be found by following this link.
