FDA Researcher Says Five Drugs Need to Be Critically Reviewed for Safety Reasons

FDA Reviewer Says 5 Drugs Need Closer Scrutiny
Thu Nov 18, 2004 05:34 PM ET
By Lisa Richwine and Ransdell Pierson

WASHINGTON/NEW YORK (Reuters) - A U.S. Food and Drug Administration reviewer who has accused the agency of being lax in monitoring drug safety on Thursday said five medicines on the market need closer scrutiny.

Shares of several makers of the drugs, including British rivals GlaxoSmithKline Plc and AstraZeneca Plc, fell sharply after the testimony.

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

"There are at least five drugs on the market today that I think need to be looked at quite seriously to see if they belong there," said Graham, associate director for science in the FDA's Office of Drug Safety.

Graham in August presented his FDA-sponsored study suggesting Merck & Co's arthritis drug Vioxx caused heart attacks and stroke, the month before Merck recalled its $2.5 billion-a-year drug. Graham has alleged senior FDA officials tried to suppress his findings.