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FDA Adds Black Box Warnings To Some Arthritis Drugs

Are arthritis drugs safe? Is Humira safe? Is Cimzia safe? Is Enbrel safe? Is Remicade safe? Following a study of 30 different children who were diagnosed with cancer after using prescription arthritis drugs, the US Food & Drug Administration is adding a black box warning to a number of arthritis drugs in order to reflect the drugs' potential dangers. The drugs included in the new black box warning include Humira, Cimzia, Enbrel, and Remicade.

At this point in time, the FDA explained, although the short-term safety issues of the arthritis drugs are known, the long-term effects of the drugs, such as Cimzia, have yet to be studied. Currently, a ten-year study of Cimzia will help health officials to understand what the long-term risks of the drugs are, especially as they relate to certain types of cancer including lymphoma, leukemia, and organ cancer.

The issue with studying these drugs is that children taking arthritis medication or medication for Chron's disease already have a higher risk for cancer - and those taking the medication will suffer several adverse consequences, such as deformity or disability, if they do not take the drugs. Because of these complications, the FDA is not recommending children stop taking their prescription arthritis drugs, but rather that the families and health professionals of the children should decide how to respond on an individual basis.

In addition to adding the black box warnings to the prescription arthritis drugs, the FDA made it clear that doctors and other health professionals should report any negative side effects of the drugs via the Adverse Event Reporting system.

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