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Jul 07 2011

The FDA Tells Doctors to Stop Prescribing 80mg Zocor (Simvastatin)

Posted in Product Liability

The utilization of new and powerful drugs can cause unanticipated adverse reactions to patients due to the unique composition of each person and the other medical treatments they may be receiving, says Alabama liability attorney Keith T. Belt

Food and Drug Administration told doctors to stop prescribing the top 80-milligram dose of simvastatin, also known by the brand name Zocor, to new patients because of a heightened risk of muscle pain. This decision will affect millions of patients. Script data from IMS Health shows that forms of simvastatin were prescribed 100 million times last year. The 80 milligram doses of simvastatin and Vytorin were prescribed 11.3 million and 1 million times, respectively. That means the
80 milligram dose of simvastatin was prescribed more times than all doses of Vytorin, which was prescribed 8.6 million times last year.
To keep perspective, the fact that other cholesterol-lowering statin drugs like Lipitor and Crestor are more potent probably factored into this decision — if the top dose of Zocor were the only option, the FDA might have kept it. Steven Nissen of the Cleveland Clinic, who said as early as 2004 that doctors should not be using the 80 mg dose, emphasized that statins are “among the safest and most important drugs in all of medicine” and that the risks outweigh the benefits for other doses of simvastatin, Lipitor, pravastatin and other drugs.

What’s scary isn’t so much the case of simvastatin itself — this is an issue doctors can handle — but the fact that simvastatin was approved in 1991. This drug has been on the market for 20 years. And, despite the tone of much of the coverage, this is not a medicine only taken by a few people. The FDA said that 2.1 million people had been prescribed the 80 milligram dose, either by itself or in a combination pill like Vytorin or Simcor, last year.