FDA required the manufacturers of TNF blockers (etanercept –Enbrel-, infliximab –Remicade-,adalimumab –HUMIRA-, among others) to make an update on existing Boxed Warning. This will include an alert to healthcare professionals about an increased risk of lymphoma and other malignancies in children and adolescents treated with TNF blockers.
In addition to the updated Boxed Warning, FDA is requiring several other changes to the prescribing information for TNF blockers to warn of and mitigate the risks associated with these drugs. These changes are based on additional safety reviews and include a(n):
This 2008 video was an alert on possible association between TNF blockers and the development of lymphomas. At that time, the FDA was in the middle of an ongoing safety review, and did not take any regulatory action.