FDA Knew of Crestor Dangers but Approved Drug Anyway

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http://www.citizen.org/pressroom/release.cfm?ID=1737

 

 

June 24, 2004

 

FDA Knew of Crestor Dangers but Approved Drug Anyway, Public Citizen Writes in

Lancet Medical Journal

 

More Cases of Muscle Deterioration, Kidney Failure Reported

 

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) had evidence

before approving the cholesterol drug Crestor that it caused an increased

incidence of rhabdomyolysis (severe muscle deterioration), yet the agency

approved it anyway, erroneously believing that this toxicity was limited to an

80 milligram dose that was not ultimately approved, Dr. Sidney Wolfe, director

of Public Citizen’s Health Research Group, writes in this week’s issue of The

Lancet (June 26).

 

The approval came despite the fact that agency officials had said that any new

cholesterol drug should be approved only if it has a comparable or lower risk of

rhabdomyolysis than drugs already on the market. In fact, records show that

patients taking Crestor experience severe muscle deterioration at much higher

rates than patients taking other cholesterol-lowering drugs. The rate of

post-marketing reports of rhabdomyolysis for Crestor appears to exceed that of

all other currently marketed statins (cholesterol-lowering drugs). Also, the

drug is associated with primary kidney failure.

 

“To allow AstraZeneca to continue desperately seeking a piece of the estimated

$20 billion-a-year statin market hardly justifies governments allowing this

ultimately doomed drug to stay on the market,” Wolfe wrote.

 

From the time of its approval in August 2003 to mid-April, 18 patients,

including 11 in the United States, suffered severe muscle deterioration. In

addition, there have been eight reported cases of acute kidney failure and four

of kidney insufficiency, according to data obtained from the FDA. Most of these

patients were using the low 10 milligram dose. More than 20 additional cases of

rhabdomyolysis have been reported to the FDA since mid-April, agency sources

say.

 

In March, Public Citizen filed a petition with the FDA to have the drug taken

off the market. The petition is still pending. Meanwhile, AstraZeneca has

launched a major direct-to-consumer advertising campaign to promote the drug.

 

Crestor is the only statin that exhibited rhabdomyolysis before being approved

by the FDA.

 

To view the Lancet article,

 

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