The U.S. Food & Drug Administration (FDA) has issued a black box warning for TNF (Tumor Necrosis Factor) Alpha Blockers such as Johnson & Johnson's Remicade and Simponi, Abbott Lab's Humira and Amgen & Wyeth's Enbrel after finding that these drugs may increase the risk of lymphoma and other cancers in children and adolescents. The drugs, which suppress the immune system, are generally used to treat juvenile rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, inflammatory bowel disorder and Crohn’s disease.

Second black box warning

The FDA's latest black box warning on TNF Alpha Blockers (the first was issued in September of 2008 warning of the increased risk of serious fungal infections) was issued on 8/4/09. In it, the FDA:

• reported that approximately 30 children using Remicade, Enbrel and Humira in the 10 year period from 1998 to 2008 reportedly developed cancer. About half of those cancers were lymphomas, including both Hodgkin’s and non-Hodgkin’s lymphoma. The other cancers – some of which were fatal – included leukemia, melanoma and solid organ cancers.
• concluded that there is an increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents.
• identified new safety information related to the occurrence of leukemia and new-onset psoriasis in patients treated with TNF blockers.
• said it will require updates to the current Medication Guide to help patients understand the risks associated with TNF blocker therapy.

Lawsuits against manufacturers continue; one woman collects $20M

Numerous lawsuits against manufacturers Johnson & Johnson, its subsidiary Ortho Biotech, Inc., Abbott Laboratories, Amgen and Wyeth Laboratories have been filed and product liability attorneys say that many more are likely – especially now with the FDA's second black box warning. One trial has already resulted in a $20 million verdict for a Remicade user. She was awarded the $20 million ($15M of that was for punitive damages against the manufacturer) after contracting Lupus while on Remicade. The jury found that the manufacturer did not warn her about the possible side effects of taking the drug.

Links to additional information

Below are links to additional information consumers may find useful:

• FDA's August 2009 warning
• Article on Cimzia with links to drug's website
• Article on Enbrel with links to drug's website
• Article on Humira with links to drug's website
• Article on Remicade with links to drug's website
• Free case review for injured victims