FDA Warns Against High Doses Of Cholesterol Drug

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The Food and Drug Administration is warning that a popular cholesterol drug can cause muscle damage at high doses. The FDA is telling patients to see their doctor if they're taking the highest dose of Zocor, known generically as simvastatin.

STEVE INSKEEP, host:

It's MORNING EDITION, from NPR News. I'm Steve Inskeep.

LINDA WERTHEIMER, host:

And I'm Linda Wertheimer.

The Food and Drug Administration is warning that a popular cholesterol drug can cause muscle damage at high doses. NPR's Richard Knox says the evidence has been accumulating for a long time.

RICHARD KNOX: The drug is called simvistatin or Zocor. More than two million Americans are taking 80 milligrams of simvistatin. That's the dose the FDA's worried about. Dr. Steven Nissen of Cleveland Clinic says there's lots of evidence high-dose simvistatin can cause serious muscle damage.

Dr. STEVEN NISSEN (Cleveland Clinic): I would have taken it off the market years ago. There are alternatives. There's no reason to keep it on the market at this point.

KNOX: Amy Egan of the FDA says the agency didn't want to take 80 milligram simvistatin off the market because it's cheaper than other statin drugs. She says people on the drug for more than a year with no problems should continue to take it.

Ms. AMY EGAN (FDA): there are very few people who walk around who don't have an ache or pain here and there. Our concern is people are going to stop their statins because they think their ache or pain is related to their statin.

KNOX: But the FDA doesn't want doctors to start patients on high-dose simvistatin because there are safer alternatives.

Richard Knox, NPR News.

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