Group: Crestor Side Effect Report DelayedAug 4, 2004 | 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.