Public Citizen’s Health Research Group (HRG)’s petition was based on adverse reaction reports of life-threatening muscle damage (rhabdomyolysis) and kidney failure or impairment in patients taking Crestor. The FDA’s rejection of the petition followed a thorough analysis of clinical trial safety data and post-marketing data.
In a response letter, the FDA stated that all of the available evidence indicates that Crestor (rosuvastatin calcium) does not pose a risk of muscle toxicity greater than the other approved statins, and that, with respect to renal toxicity, there is no convincing evidence that Crestor poses a serious risk of renal injury.
Recently the FDA approved revisions to the Crestor prescribing information, which strengthened language around the appropriate use of Crestor. At the same time, the FDA issued a statement confirming that the potential benefits of Crestor outweigh the potential risks when taken as directed.
“Patient safety is our top priority and the FDA’s rejection of Public Citizen’s petition should reassure the millions of people who have been unnecessarily alarmed by HRG’s allegations,” said David Brennan, president and CEO of AstraZeneca US.
Public Citizen’s response to this news was to compare the FDA’s decision to the agency’s initial response to the dangers of other drugs that were eventually banned, such as Bayer’s Baycol and Merck & Co’s Vioxx, and to accuse the FDA of choosing a “drug company over safety”.