Biologic Drugs and Safety Issues
One-Quarter of Biologic Drugs Have Had Safety Issues
International analysis finds 11% issued ‘black box’ warnings by FDA
By Amanda Gardner
HealthDay Reporter
(SOURCES: Lisa Saubermann, Pharm.D., associate director, clinical pharmacy services, University of Rochester Medical Center, New York; Phil B. Fontanarosa, M.D., executive deputy editor, Journal of the American Medical Association; Oct. 22/29, 2008, Journal of the American Medical Association)
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.
“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.”
Read the rest of this article at http://www.healthfinder.gov/news/newsstory.aspx?docID=620466.
