FDA Rejects Bid to Ban Cholesterol Drug
Agency Says Crestor Is No Riskier Than Other Cholesterol-Lowering Drugs
March 14, 2005 - Federal health regulators on Monday rejected
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.
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.