Safety of Biological Drugs Examined in New Study

October 2008

A report published in the Journal of the American Medical Association has revealed that nearly one in four biological drugs, including Enbrel, Humira, Tysabri, and Raptiva, has required some type of regulatory action to ensure patient safety. In each instance, regulation occurred after the medications were available to the public.

The active ingredient in biologicals comes from the living cells of animals or humans. Of the 174 biologicals approved since 1995, 82 have required regulatory action, including black box warnings, the strongest warning a drug can receive. Often, the safety risk was related to the drug’s effect on the immune system, resulting in infections. For example, serious infection risk prompted safety alerts for the arthritis and psoriasis drug Enbrel, Johnson & Johnson’s Remicade, and Abbott Laboratories’ Humira.

Most recently, the psoriasis drug Raptiva received warnings about the risks of a life-threatening infection called progressive multifocal leukoencephalopathy. This condition has also been linked to the lymphoma medicine Rituxan and the multiple sclerosis drug Tysabri.

On average, regulatory action took place almost four years after the biological’s approval. The study’s authors recommended that doctors be particularly aware of the risks that this drug class presents so they can better identify warning signs in patients. So far, none of the potentially dangerous drugs have been removed from the market.