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Doctor is critical of FDA delay in recognizing danger of 80 mg doses of Simvastatin

Last week when the FDA warned against the use of 80 mg doses of simvastatin because nearly one percent of patients suffer severe muscle damage, Dr. Steven Nissen of the Cleveland Clinic publicly criticized the Agency for its dilatory action.  Nissen, who was widely applauded for his independent investigation and criticism of the pharmaceutical industry, pointed out that the drug has been recognized as unreasonably dangerous--with safer, effective options--for 11 years.  He noted that he stopped prescribing the 80 mg dose seven years earlier.

The drug poses an unacceptable risk of rhabdomyolysis, which can cause kidney failure and death.  Nevertheless, simvastatin is the second most widely prescribed drug in the U.S., with 2.1 million Americans currently taking it to lower cholesterol.  Thus the financial stakes are high and another cheap alternative won't be available until fall of 2011 when Lipitor becomes available in a generic.  Currently, non-generic statin drugs run about $1.20 per day for a patient, which simvastatin costs only four cents per day.

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