By Robert Bazell Chief science and health correspondent
NBC News
updated 6/24/2004 9:31:12 PM ET 2004-06-25T01:31:12

Otis Elliott started taking the cholesterol-lowering drug Crestor and developed severe muscle pains within days.

“(I) just couldn’t stand it anymore, the pain was too severe,” says Elliott. But by then it was nearly too late; Elliott went into kidney failure, which doctors say almost killed him.

In a letter published Thursday in the medical journal The Lancet, a consumer advocacy group warns that the danger of such life-threatening side effects is unacceptably high with Crestor, a statin that was approved by the Food and Drug Administration last August.

“So everywhere you turn there are ads for Crestor and there is no question that those ads help to sell drugs, but what patients have not known and what I think a lot of doctors have not known is that the drug has unique risks," says Dr. Sidney Wolfe of the nonprofit group Public Citizen. All statins carry a slight risk of muscle damage, but the consumer group says the danger is higher with Crestor, and only Crestor threatens the kidneys.

Ever since Crestor was approved by the FDA, the manufacturer, AstraZeneca, has been heavily advertising the drug.

AstraZeneca says the concern about side effects is just flat-out wrong. “We believe the safety profile for Crestor has been very, very extensively studied and we’re confident that it is comparable to the other statins," says David Brennan, the company's CEO.

What is at stake is a potential portion of an enormous market — and human lives. Sales of statin drugs in the United States now total $14 billion a year, with 13 million people taking them. And experts say the number of people who should be taking the drugs is triple the number who are currently taking them.

FDA officials say they agree with the manufacturer that Crestor is safe and effective, but add that they will continue to study reports of harmful side effects, such as Elliott’s case, to see if they reveal an unusual pattern.

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