One-Quarter of Biologic Drugs Have Had Safety Issues

Oct. 22 -- TUESDAY, Oct. 21 (HealthDay News) -- New research shows that almost one-quarter of biologic therapies approved in the United States and Europe since 1995 have been the subject of at least one safety-related regulatory action in the decade since they were approved.

Eleven percent, including Remicade (infliximab), used to treat Crohn's disease and rheumatoid arthritis, and Avastin (bevacizumab), used to treat cancer, have been issued a "black box" warning.

The findings, from Dutch scientists, are published in the Oct. 22/29 issue of the Journal of the American Medical Association, a themed issue on the Health of the Nation.

"This suggests the need for more in-depth investigation before approval and highlights the importance of vigilance in post-marketing surveillance for adverse effects," Dr. Phil B. Fontanarosa, the journal's executive deputy editor, said during a a Tuesday teleconference on the themed issue.

"[Adverse effects] generally occurred in general disorders, like serious allergic reaction or cardiac arrest, administration site problems, infections and infestations," said Fontanarosa. "A lot of these drugs act on the immune system, so infections are common complications of these products."

"We've always known that because biologics were going to modulate the immune system, there would be this risk," said Lisa Saubermann, associate director of clinical pharmacy services at the University of Rochester Medical Center. "Any time we modulate the immune system, that's the problem, because we know that the immune system is preventing other things from happening, like cancers."

"It's alarming," she added.

The first biologic treatment, recombinant insulin, was approved in the United States in 1982. Since then, more than 250 biologics have flooded the pharmaceutical market, representing roughly one-quarter of all new drugs approved by U.S. and European Union authorities.

Although all drugs carry risks, biologics are in a special class, because they are derived from biological sources, including antibodies, enzymes and hormones.