The Scary Thing About the FDA’s Simvastatin Decision - Matthew Herper - The Medicine Show - Forbes

Yesterday the 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.

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.

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. Vytorin generated $1.3 billion in U.S. sales last year, according to IMS. This is like the FDA telling doctors to stop using a blockbuster drug.

What’s really food for thought, though, is that this risk emerged after the top dose of simvastatin was studied by Merck in two very large trials, A to Z and Search, and then very quickly rose to become a super-popular medicine after it went generic. The FDA then did its own study of side effect reports sent in by doctors and patients. Most drugs get nowhere near this much scrutiny. That’s why, when taking a medicine, it’s always fair to ask not just what the side effects are, but what they might be.

Remember though, that simvastatin’s benefits could still outweigh its risk were it not for the fact that the creation of a bunch of me-too drugs like Lipitor and Crestor gave patients who need high-octane cholesterol drugs even better options.

Simvastatin Snapshot
	Number of prescriptions, 2010
All cholesterol drugs	253 million
simvastatin, all doses	94.3 m
simvastatin alone, 80 mg	11 m
Vytorin, all doses	8.6 m
Vytorin, 80mg	1.3 m
Simcor, all doses	0.94 m
Simcor, 80mg	0.18 m
All simvastatin, 80mg	12.4 m
Source: IMS Health

 

via blogs.forbes.com

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