"They didn't act boldly enough in my opinion," says Steven Nissen, M.D., chairman of cardiovascular medicine at the Cleveland Clinic. A persistent FDA and drug company critic, Nissen wrote a September 2004 JAMA editorial warning of the problem.
"The people who are knowledgeable in the lipid field have known that the 80 mg dose of simvastatin was unsafe, and we've known it for a long time," Nissen says. "The incidence of muscle injury is anywhere from seven to 15 times more prevalent with the 80 mg dose than any of the other marketed statins."
Simvastatin is riskier in part because it interacts with a variety of other medications, and the risk increases with higher doses, he says. An urgent care visit could easily result in being given an antibiotic like erythromycin, which reacts badly with simvastatin, he says. "My advice to patients is don't take the 80 mg dose. It's just not worth it."
Michael Rosenblatt, M.D., Merck's executive vice president and chief medical officer, defends the FDA recommendation. "You have to do the trade-off here," he says. "In general, if somebody is on this drug for a year or more and they are tolerating it well — that is, without muscle problems — then the benefits of staying on it outweigh the risks." Those most at risk for muscle problems include women, people over 65 and those with kidney problems or uncontrolled hypothyroidism.
Both the FDA and Merck caution patients using the 80 mg dose of simvastatin not to discontinue taking it without consulting their doctors.
You may also like: Dairy fat may lower diabetes risk. >>
Michael Haederle is a freelance writer whose work has appeared in People, the New York Times and the Los Angeles Times.