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FDA warnings on five drugs prompt worries

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A day after an FDA official raised safety concerns about five widely prescribed medicines, doctors and patients had the same question: Should they still use the drugs?

David Graham, the Food and Drug Administration's associate director of drug safety, testified before a Senate committee Thursday that not only had his agency not given enough weight to safety concerns about the recalled painkiller Vioxx but also that regulators should look closely at five other drugs.

They are:

Pfizer's Bextra, a pain reliever in the same class as Vioxx.

AstraZeneca's Crestor, a cholesterol-lowering drug.

Abbott Laboratories' Meridia, a weight-loss drug.

Roche Holding's Accutane, an acne drug.

GlaxoSmithKline's Serevent, an asthma medicine.

Drug makers defended their products. Most already carry the FDA's "black box" warnings -- the strongest alert -- on their labels regarding safety issues. The five drugs have been approved as safe and effective by the FDA and "continue to be closely monitored with regard to safety and the balance of benefit to risk," FDA spokeswoman Kathleen Quinn said Friday.

Medical experts say patients should not stop taking those medications without consulting their physicians. Representatives of the makers of the five drugs have said they are safe and effective when used as directed.

Public Citizen, founded by Ralph Nader, has asked the FDA to remove Crestor and Meridia from the market. Sidney M. Wolfe, the director of Public Citizen's Health Research Group, said Friday that he thinks Bextra should also be pulled.

"All these drugs are very problematic," Wolfe said. He said that when FDA officials such as Graham raise questions, "their views are usually squelched. The FDA is too beholden to the manufacturers."

The problems "are generally known within the FDA, but the agency silences people who criticize the drugs or the policies," he said.

Daniel A. Hussar, a professor of pharmacy at the University of the Sciences in Philadelphia, said Bextra is the only drug of the five that he thinks should be removed from the market. He said studies have indicated an increased risk of heart attacks and an association with a rare but potentially fatal skin reaction.

However, consumers should not be "unnecessarily alarmed" about health risks, he said. "Physician offices have to be overwhelmed with calls, but I think the alarm is excessive. When the drugs are appropriately used and in appropriate doses, they can be safe."

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