Crestor risk higher than in other statins, consumer group says
The findings contradict an FDA statement last week that the risks of muscle injury from Crestor were the same as in related drugs.
Public Citizen renewed its call for the FDA to ban Crestor immediately, according to a Reuters report this morning.
The consumer group said it reviewed reports of cases of rhabdomyolysis submitted to the FDA between Oct. 1, 2003 and Sept. 30, 2004 and compared them with the number of prescriptions filled for each drug.
For Crestor, there were 13 reports of rhabdomyolysis for every million prescriptions filled, Public Citizen estimated. That rate was 6.2 times higher that the rates for all other statins combined.
The lowest rate among other statins was 0.6 reports per million prescriptions of Bristol-Myers Squibb's Pravachol.
"These data affirm the pre-approval findings from clinical trials of increased muscle damage rhabdomyolysis for Crestor compared with other statins and refute the FDA statement that the rates are 'similar,'" Public Citizen said in a letter to FDA acting commissioner Lester Crawford.
The FDA completed a review of Crestor last week, concluding its risks of causing muscle injury were similar to those of other statins. To reduce risks, physicians were asked to consider the lowest possible dosage for at-risk patients.