FDA rejects Public Citizen’s Crestor petition
The agency said its rejection of the petition was based on its analysis of clinical trial safety data and post-marketing data.
Public Citizen submitted the petition a year ago and last week supplemented it with data linking Crestor with six times as many reports of muscle damage per million prescriptions than the combined total of all other statins.
The response letter from the FDA said all available evidence indicates that Crestor does not pose such a risk.
Recently the FDA approved revisions to Crestor prescribing information, telling doctors to start some patients at a lower doses and to check for certain medical conditions before prescribing the drug.
Public Citizen attacked the agency's decision as having "a familiar ring in its similarity to the agency's initial response to the dangers of many other drugs that were eventually banned," according to a report on the Web site TheStreet.com. The FDA's action "should give no comfort to either physicians or patients who are using or considering using Crestor," Sidney Wolfe, director of Public Citizen's Health Research Group said in the online report.
Crestor sales topped $908 million last year.