TNF blockers and lymphoma: FDA adds boxed warning

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):

Update to the Warnings section describing reported cases of leukemia in adults, adolescents, and children. Changes to the Warnings section of the labeling will also include additional information on malignancies in children and adolescents (see also Boxed Warning information above).

Update to the Adverse Events section to include information on reported cases of new-onset psoriasis.

Source.  FDA alert: Information for Healthcare Professionals: Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi).

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.

Further reading

Follow-up to the June 4, 2008 Early Communication about the Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi)

Early Communication About an Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia)