FDA Rejects Bid to Ban Cholesterol Drug

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FDA Rejects Bid to Ban Cholesterol Drug

 

Agency Says Crestor Is No Riskier Than Other Cholesterol-Lowering Drugs

 

By Todd Zwillich

WebMD Medical News Reviewed By Brunilda Nazario, MD

on Monday, March 14, 2005

 

March 14, 2005 - Federal health regulators on Monday rejected a consumer group's

call to ban the cholesterol-lowering statin drug Crestora consumer group's call

to ban the cholesterol-lowering statin drug Crestor because of fears that it

puts users at a high risk for muscle and kidney damage.

 

The FDA said it was rejecting a petition from drug industry watchdog Public

Citizen because there was no evidence that Crestor was any more dangerous than

other cholesterol-lowering statins already on the market.

 

The group filed a petition with the FDA in March of last year urging the agency

to pull Crestor from the market because of a high rate of kidney failure and the

muscle-damaging disease rhabdomyolysis associated with its use.

 

The group says 68 cases of rhabdomyolysis and 15 cases of kidney failure were

reported to the agency and drug companies in the year ending October 2004. Some

5.2 million Crestor prescriptions were written in that time, though the majority

of reports did not conclusively identify the drug as the cause of the reactions.

 

An FDA statement accompanying the rejection says the agency found no evidence in

clinical trials or in postmarket safety monitoring that Crestor was more

dangerous than other statin drugs, including Lipitor and Zocor.

 

" Our review of all of the available evidence ... indicates that Crestor does not

pose a risk of muscle toxicity greater than that of other approved statins, " an

agency statement reads.

 

Crestor manufacturer, AstraZeneca, last week revised the drug's

label,AstraZeneca, last week revised the drug's label, urging doctors to use the

low 5-milligram dose of the drug in some patients at higher risk for

complications. Such patients included Asians, those taking immune-suppressant

drugs like cyclosporine, and those with kidney disease.

 

The company also said doctors should reserve the drug's highest dose, 40

milligrams, for patients who do not achieve sufficient cholesterol lowering at

lower doses.

 

" This should reassure the millions of people who have been unnecessarily alarmed

by Public Citizen, " says AstraZeneca spokeswoman Rachel Bloom-Baglin.

 

Sidney Wolfe, MD, director of Public Citizen's Health Research Group, says the

FDA's refusal to order Crestor off the market had a " familiar ring " to its

action with Vioxx and other drugs, where it refused to act on early safety

warnings.

 

" Once again, when faced with concerns about the safety of a drug, the FDA has

sided with the drug company, " he says in a news release.

 

" This response should give no comfort to either physicians or patients who are

using or considering using Crestor, " Wolfe says.

 

 

--

 

SOURCES: FDA. Rachel Bloom-Baglin, spokeswoman, AstraZeneca. Sidney Wolfe, MD,

director, Public Citizen's Health Research Group.

 

 

© 2005 WebMD Inc. All rights reserved

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