US drug expert raises alarm bells over five medications

AT least five medications now sold to consumers pose such risks that their sale should be limited or stopped, said a government drug reviewer who raised questions earlier about the arthritis drug Vioxx.

In testimony on Thursday before the US Senate Finance Committee, Food and Drug Administration reviewer David Graham cited Meridia, Crestor, Accutane, Bextra and Serevent.

The nation is ‘‘virtually defenceless’’ against a repeat of the Vioxx debacle, he said. Merck & Co pulled Vioxx from the market on September 30 after a study indicated the painkiller doubled the risk of heart attacks and stroke when taken for longer than 18 months.

Committee chairman Senator Charles Grassley suggested an independent board of drug safety may be needed to ensure the safety of medications after FDA approval. An ‘‘awful lot of red flags’’ were raised before Vioxx was withdrawn, said Mr Grassley, and the agency disdained, rather than listened to, its own reviewers.

The five most worrisome drugs in question are: Meridia: a weight-loss drug. Mr Graham said the agency should consider whether its benefits outweigh the risks of higher blood pressure and stroke of people taking it.

Crestor: an anti-cholesterol drug. Mr Graham said the US government should evaluate the occurrence of renal failure and other serious side effects among people taking Crestor.

Accutane: an acne drug linked to birth defects.

Bextra: A painkiller. Mr Graham said the drug poses the same heart attack and stroke risk as Vioxx.

Serevent: an asthma treatment. Mr Graham said the drug was shown, with 90% certainty in a long- term trial in England, to cause deaths due to asthma.

GlaxoSmithKline, told by the FDA to do a large, clinical trial, begged off. ‘‘We’ve got case reports of people dying, clutching their Serevent inhaler,’’ Mr Graham said. ‘‘But Serevent is still on the market.’’

An FDA official yesterday “categorically rejected” Dr Graham’s accusations they had failed to protect the public. Merck & Co placed full-page advertising in newspapers highlighting the company’s commitment to transparency in research.