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Crestor Side Effect Report

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http://apnews.myway.com/article/20040804/D84831AG0.html

 

Group: Crestor Side Effect Report Delayed

 

Aug 3, 8:40 PM (ET)

 

WASHINGTON (AP) - A drug company illegally delayed

reporting side effects linked to its anti-cholesterol

drug Crestor, a consumer advocate contended Tuesday in

urging a Food and Drug Administration investigation.

 

It's the latest attack on Crestor by the private group

Public Citizen, which argues that Crestor is riskier

than its competitors and should be banned.

 

FDA requires drug makers to reveal reports of serious

and unexpected side effects within 15 days of learning

about them. While those reports don't prove a drug was

to blame, FDA evaluates them to determine whether a

medicine is riskier than initially thought.

 

Public Citizen's Dr. Sidney Wolfe charged that

AstraZeneca delayed its reports to the FDA by as long

as 97 days. The company ultimately reported that 19

Crestor users suffered an often life-threatening

muscle-destroying condition - and filed four reports

of kidney failure.

 

The delays " have unquestionably impaired FDA's ability

to promptly assess the safety of this uniquely

dangerous drug, " Wolfe wrote FDA Acting Commissioner

Lester Crawford Tuesday.

 

AstraZeneca insists that Crestor is no more risky than

other cholesterol-lowering " statin " drugs, and that it

followed FDA rules. The company says it wasn't subject

to the 15-day deadline because the side effects were

mentioned on the drug's label.

 

Wolfe countered that Crestor's label implies the

muscle-destroying side effect occurs only with an

unapproved high dose. The company's own reports,

however, implicate far lower doses. The drug's label

only mentions kidney failure in passing, Wolfe said.

 

FDA hasn't formally determined whether AstraZeneca

should meet the 15-day deadline, said Dr. Mary Parks,

medical officer.

 

So far, the agency says it sees no signal that Crestor

is riskier than other statins, which all can cause

rare cases of the muscle side effect.

 

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