Vioxx creates trouble for FDA

ASSOCIATED PRESS

The public is “virtually defenseless” if another medication such as Vioxx proves unsafe after it has won Food and Drug Administration approval, a government drug-safety expert said yesterday.

“I would argue that the FDA as currently configured is incapable of protecting America against another Vioxx,” said Dr. David Graham, who warned that the arthritis-relief drug had been linked to an increased risk of heart attack and stroke.

He told the Senate Finance Committee of at least five other drugs on the market that warrant scrutiny: the acne-reducing drug Accutane, the weight-loss drug Meridia, the cholesterol-lowering drug Crestor, pain-reliever Bextra and the asthma-relief drug Serevent.

Astra-Zeneca Pharmaceuticals, maker of Crestor, said it was confident that the drug was safe.

“To date, the FDA has not given us any indication of a major concern regarding Crestor,” spokeswoman Emily Denney said.

Tim Lindberg, a spokesman for Abbott Laboratories, said, “Science continues to support the safe use of Meridia to treat obesity, the leading health epidemic in the U.S.”

Carolyn Glynn, spokeswoman for Roche Holdings AG, a manufacturer of Accutane, noted the drug is intended for serious cases and does carry risks.

“This drug is extremely beneficial as long as it’s used safely and appropriately,” she said.

GlaxoSmithKline, which makes Serevent, said the medication is safe and effective “when used appropriately and in accordance with labeling and treatment guidelines.”

Representatives of Pfizer, the manufacturer of Bextra, were not available yesterday.

A second FDA official, Dr. Sandra Kweder of the Office of New Drugs, did not agree with Dr. Graham’s assessment of the risk posed by the five drugs.

She said, “There is no magic formula” to determine which drugs most raise the most serious safety concerns.

Vioxx’s maker, Merck & Co., pulled the drug from the market on Sept. 30 after a study indicated the popular painkiller doubled the risk of heart attacks and stroke when taken for longer than 18 months.

Raymond V. Gilmartin, the company president, said in prepared testimony that Merck acted within four days of learning about the risk.

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