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FDA Official Lists Five Drugs As Possible Dangers to Health

By Matthew Kelly

Hearst Newspapers WASHINGTON

A Food and Drug Administration official warned Congress on Thursday that the FDA would be unable to prevent another episode like the Vioxx case, where the popular arthritis drug was approved for sale but later withdrawn when it was found to be unsafe.

David Graham, a drug safety reviewer at the FDA, told the Senate Finance Committee that the regulatory agency’s culture “undervalues, disregards and disrespects drug safety,” and treats the powerful pharmaceutical industry as its client.

“I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx,” Graham said. “We are virtually defenseless.” He listed five drugs now in the marketplace that he said could pose safety problems.

Graham singled out five other drugs on the market that may be unsafe, even though he said he “didn’t want to affect the spot price of the drug companies.”

The five were:

-- Meridia, a weight loss drug made by Abbott Laboratories; Graham said it raises blood pressure and increases risk of stroke.

-- Crestor, a cholesterol-lowering drug made by AstraZeneca; Graham said it has been linked to kidney failure.

-- Accutane, an acne medication made by Roche; Graham said it causes birth defects when used by pregnant women.

-- Bextra, a pain reliever made by Pfizer; Graham said it raises risk of heart attacks and strokes.

-- Serevent, an asthma medication made by GlaxoSmithKline; Graham said the drug actually has caused death from asthma and that people have been found dead clutching their Serevent inhalers.

Graham led a three-year FDA-funded study that concluded in August that Vioxx increased the risk of heart attack one-and-a-half to three-and-a-half times over its leading competitor, Celebrex.

He estimated that 88,000 to 139,000 Americans suffered heart attacks or strokes due to Vioxx over the five years the drug was on the market.