New Study Cites Safety Problems with Biological Medicines

Infections Most Common Safety Issues

According to a new study published today in the Journal of the American Medical Association, biological agents, a relatively new class of medical therapeutics, carry an increased risk for safety problems. Some of the biologics included in the study were the arthritis drugs Humira and Remicade, cancer drugs Rituxan and Erbitux, and the heart failure drug Natrecor. All of these have had safety issues.

The report, the first of its kind, evaluated 174 biologics approved between January 1995 and June 2008 in the European Union and the United States. Overall, 41 drugs, which is nearly 25 percent or a quarter or the new therapies, received safety warnings though June 2008.

The authors concluded that the adverse events commonly seen with these new agents are related to the immune system - what's known as immunomodulatory effects or infections. And, agents that were the first type of agent in their class to be approved tended to be subjected to regulatory action, therefore warranting close monitoring when used.

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Published on Oct-21-08