FDA stands by safety of approved drugs after insider's criticism

The US Food and Drug Administration has said 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 last week, singled out Abbott Laboratories 's weight-loss drug Meridia, AstraZeneca's cholesterol fighter Crestor, Pfizer's arthritis treatment Bextra, Roche's acne drug Accutane and GlaxoSmithKline's asthma drug Serevent.

Graham said a serious look was needed at the chances of Crestor causing kidney failure and a potentially fatal muscle breakdown.

"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.

European ProbeM

The European Medicines Agency (EMEA) also said it was investigating whether all patients taking Crestor should start on the lowest 5 milligram dose following a referral from Britain sparked by "public health concerns".

AstraZeneca's Chief Executive Tom McKillop said there was no indication that the FDA was considering a similar shift to a normal 5 mg starting dose.

The current normal starting dose is 10 mg, and anything lower could reduce the medicine's competitive profile against rivals, including Pfizer's best-selling Lipitor.