Warnings, COLUMNS-Drugs & Supplements, November 2004

FDA Acting Commissioner Says Agency Will Strengthen Safety Program for Approved Drugs

WASHINGTON, D.C. - Acting FDA Commissioner Dr. Lester M. Crawford issued a warning Nov. 5 that the "full magnitude of some potential risks" may not emerge until after drugs have been approved for safety and effectiveness.

But Dr. Crawford said the FDA has a drug safety program in place to provide ongoing assessment of adverse events, and it was that program that identified recently publicized concerns with anti-depressants and the painkiller Vioxx.

"Detecting, assessing, managing and communicating the risks and benefits of prescription and over-the-counter …