FDA Focus on TNF Blockers

TNF blocker manufacturers must perform enhanced safety surveillance

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) A class of drugs is now under suspicion of causing cancer in children, adolescents and young adults under the age of 30. These are called Tumor Necrosis Factor (TNF) blockers, and the U.S. Food and Drug Administration (FDA) recently released an update regarding its ongoing safety review of these drugs.

The FDA is now requiring manufacturers of TNF blockers to conduct in-depth follow-up of any reported cases of cancers in patients receiving these drugs.

"Ask your doctor about the safety of TNF blockers."

TNF blockers are used for the treatment of:

  • Crohn's disease
  • Ulcerative colitis
  • Rheumatoid arthritis
  • Ankylosing spondylitis
  • Psoriatic arthritis
  • Plaque psoriasis
  • Juvenile idiopathic arthritis

This enhanced safety surveillance covers the following:

Manufacturers must submit reports of malignancies to the FDA within 15 days of being made aware of cases. These companies must also provide the FDA with annual summaries of malignancies and TNF utilization data.

In making the announcement, the FDA said, "This type of safety surveillance is important for our improved understanding of malignancies in pediatric and young adult patients treated with TNF blockers because it will allow FDA to more completely capture and analyze all reported malignancies based on more complete and consistent reports."

The agency also urges healthcare professionals to be watchful of patients who develop cancer while taking TNF blockers. Such cases are to be reported to the FDA MedWatch program.

Cases of malignancy associated with TNF blockers were previously reported by the FDA in June 2008, August 2009 and April 2011.

Reviewed by: 
Review Date: 
November 8, 2011
Last Updated:
November 21, 2011