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Published on May 18, 2005 by Edgar Snyder

Crestor May Pose More Threat

Crestor

Do you have high cholesterol? If so, you may be one of the millions of people taking Crestor. And that’s what worries the consumer interest group, Public Citizen. The group is criticizing the Food and Drug Administration (FDA) for not pulling Crestor from the market amid reports that the drug has six times higher the risk of muscle damage compared to other cholesterol-lowering drugs.

Crestor, an anti-cholesterol drug (also referred to as a statin drug) comes under scrutiny as the FDA cracks down on drug safety. Crestor came on the market in 2003 and only began carrying warning labels about its safety this past March. Baycol, another statin, was already pulled from shelves after being linked to at least 31 deaths from rhabdomyolysis, a deadly muscle condition. Since March of 2004, Public Citizen has been leading the campaign to also have Crestor recalled after reports showed a disproportionate amount of adverse reactions to the anti-cholesterol drug.

A recent Tufts University study, based on side effects reported to the FDA, supports Public Citizen's concerns. The study reported that kidney problems and severe muscle weakness were two to eight times more frequent among Crestor users than those taking other statins.

In December 2004, the FDA posted an agency letter requesting Crestor’s manufacturer, Astra Zeneca, remove advertisements that made “false or misleading” claims about the drug’s safety. In a defiant response to the FDA’s investigation into Crestor’s risk, AstraZeneca advertised in national and regional publications defending the anti-cholesterol drug’s safety.

Crestor garnered attention last November when an FDA whistle-blower named it one of five drugs posing as a serious safety risk. It is considered the only statin that causes acute kidney failure and can also cause an increased risk of rhabdomyolysis.

Disclaimer: All drug-related litigation will involve co-counsel.

Sources: "FDA asks drugmaker to discontinue ad." By Rita Rubin. USA Today. December 23, 2004.
“Crestor warnings too weak, group says.” By Julie Appleby. USA Today. March 10, 2005.
"New study finds higher risk in cholesterol drug Crestor." By Thomas Ginsberg. The Pittsburgh Post-Gazette. May 24, 2005.
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