FDA to review four TNF drugs for cancer risk

June 5, 2008

The Food and Drug Administration has begun a safety review of four tumor necrosis factor (TNF) inhibitors, after receiving over reports of cancer caused in children who were taking them.

The Food and Drug Administration has begun a safety review of four tumor necrosis factor (TNF) inhibitors, after receiving over reports of cancer caused in children who were taking them.

The four drugs are certolizumab (Cimzia), etanercept (Enbrel), adalimumab (Humira), and infliximab (Remicade). They treat a variety of immune system disorders, including Crohn's disease, plaque psoriasis, and juvenile idiopathic, rheumatoid, and psoriatic arthritis.

Lymphomas were half of the reported cancers: others included leukemia and melanoma.

All four drugs already carry warnings that they have been linked to cancers. There have been over 30 reports of children's cancers over the last decade. FDA is also requiring certolizumab manufacturer UCB Pharma to conduct a long-term risk study, which will take 10 years to complete.