FDA now Requires Stronger Warning Labels for Tumor-necrosis Factor-alpha Blockers

The FDA is now requiring that stronger product warnings be included in the prescribing information of tumor necrosis factor-alpha blockers (TNF-blockers) because of an increased risk of cancer in the children and adolescents who take these drugs to treat rheumatoid arthritis (RA), Crohn’s disease, and other inflammatory diseases.

The new standards, which include an updated boxed warning, come as a result of an investigation by the FDA that first began in June 2008. According to the FDA, “an analysis of U.S. reports of cancer in children and adolescents treated with TNF-blockers showed an increased risk of cancer, occurring after 30 months of treatment on average.” About half of the cancers found were lymphomas, and, according to the FDA release, “some of the reported cancers were fatal.” An article about the new warnings from the Wall Street Journal’s MarketWatch stated that a boxed warning is “the sternest warning a product can carry in the U.S. and still remain on the market.”

As part of the new prescribing information, TNF-blockers will also include information on reports of psoriasis which has been associated with the use of this class of drugs.

The FDA is currently “working with manufacturers to explore new ways to further define the risk of cancer in children and adolescents who use these drugs,” according to the release.

For more information, please click on the links below:

• Early Communication about an Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers
• Follow-up to the June 4, 2008 Early Communication about the Ongoing Safety Review of Tumor Necrosis Factor