FDA Requiring Black Box Warnings for Certain Arthritis Drugs

By Rachel Stockton (rachels@foodconsumer.org)

After studying the records of 30 children who contracted cancer after using certain arthritis and Crohn's drugs, the FDA is calling for a black box warning on the following prescriptions: Humira, Cimzia, Enbrel, and Remicade.

Additionally, the onus is on Cimzia to conduct a ten year study that will focus on the long-term risks of the product, including cancer. The FDA maintains that such long-term analysis should be conducted in order to assess long term risk, since the only studies available quantify short-term health issues.

These drugs are classified as tumor necrosis factor (TNF) blockers. They work by intercepting a specific protein that if unimpeded, can lead to inflammation and damage to bones, cartilage and other soft tissue.

In response to the FDA announcement, the Arthritis Foundation stresses the fact that patients who have inflammatory diseases, such as rheumatoid arthritis and Crohn's, are already more susceptible to cancer, even without taking the drugs. And, if medications are not taken, children may end up disabled and deformed; the decision will need to be assessed by each individual patient.

The cancers linked to the drugs include lymphoma, leukemia and certain organ cancers. Risk appears to elevate once a patient has been on the drugs for roughly 30 months.

Per its website, the FDA urges medical professionals to report any negative side effects of the drugs to their MedWatch Adverse Event Reporting program. Forms are available on the site.