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Crestor Study Raises More Safety Issues

FDA Previously Strengthened Warning on Drug Label

May 24, 2005
More trouble for Crestor, the Astra-Zeneca statin that's been the target of safety complaints. Researchers from Tufts-New England Medical Center have found that Crestor has the poorest safety profile of the most commonly used anti-cholesterol drugs, the others being Lipitor, Zocor and Pravachol.

Crestor • Tufts Study Finds Crestor Most Dangerous Statin • FDA Issues Crestor Advisory

The study, published in the latest issue of Circulation, the Journal of the American Heart Association, found the most serious reactions resulted in damage to the kidney (proteinuria/nephropathy), and muscle (rhabdomyolysis), which frequently resulted in patients requiring hospitalization.

In March, the FDA issued a public health advisory outlining the identified risks and benefits of Crestor but critics argued the agency didn't go far enough.

David Graham, a safety researcher at the FDA, had singled out the drug as deserving closer safety scrutiny during congressional hearings last fall.

The advocacy group Public Citizen has also targeted Crestor and issued a blistering denunciation of the FDA's action, calling "another example of the agency’s dangerous cowardice in failing to adequately protect people in this country from uniquely dangerous prescription drugs."

But the lead author of the Tufts study said it's important not to overstate the dangers of the drug.

"It is very important to note that as a family, statins are very safe drugs that have clearly been shown to reduce the risk of heart disease," said Richard H. Karas, MD, PhD, lead author of the study.

"Although rosuvastatin (Crestor) was found to be less safe than others, it does not mean patients should immediately stop taking this medication."

"In fact, the overall risks of rosuvastatin remain low, and people taking this drug should talk to their doctor before deciding whether to continue on it or stop it," Karas emphasized.

Karas and his colleagues analyzed 145 rosuvastatin-associated adverse events reported to the U.S. Food and Drug Administration over its first year of marketing and compared the rates of such events with other statins simultaneously and during their respective first year of marketing.

The review found that with either comparison, rosuvastatin (Crestor) was significantly more likely to be associated with rhabdomyolysis, proteinuria, nephropathy or kidney failure.

"This study raises concern about the safety of this drug at the range of doses currently used in common clinical practice in the general population," said Karas. "I would advise healthcare providers to consider other statins as first-line therapy, to initiate therapy in appropriate patients at lower doses, to consider combination LDL-C lowering therapy, and to closely monitor patients for adverse events if rosuvastatin (Crestor) is used."

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