FDA stands by safety of approved drugs

The U.S. Food and Drug Administration said on Friday that Senate testimony by a veteran FDA researcher regarding safety risks for five drugs does not reflect the views of the agency.

Dr. David Graham, speaking at a Senate hearing Thursday, singled out Abbott Laboratories Inc.‘s weight-loss drug Meridia, AstraZeneca Plc’s cholesterol fighter Crestor, Pfizer Inc.‘s arthritis treatment Bextra, Roche’s acne drug Accutane and GlaxoSmithKline’s asthma drug Serevent.

“The five specific drugs that Dr. Graham identified in his oral testimony are currently approved as safe and effective for use in the United States,” Dr. Steven Galson, acting director for the FDA’s Center for Drug Evaluation and Research, said in a statement published on the FDA Web site.

“FDA takes all allegations of safety risks seriously and will continue its longstanding practice of assessing the safety of all drugs using only sound science and peer-reviewed analysis and literature,” Galson added.

Provided by ArmMed Media
Revision date: June 22, 2011
Last revised: by Jorge P. Ribeiro, MD