FDA Warns About Use of Zocor

Popular Cholesterol-Lowering Drug Tied to Muscle Damage

Highest approved dose of cholesterol-lowering medication could cause harm to muscles

The U.S. Food and Drug Administration recently warned patients and physicians about the potential for increased risk of muscle injury from the cholesterol-lowering medication Zocor (simvastatin) 80 mg.

Although we've known that all statins carry a risk of increased muscle injury, the warning posits the greater risk of developing muscle injury, including rhabdomyolysis, for patients when they are prescribed and use higher doses of this drug. Rhabdomyolysis is the most serious form of muscle damage and can lead to severe kidney damage, kidney failure, and sometimes death.

While the FDA is conducting ongoing research and evaluation of the drug and the effects, the FDA is clearly not waiting to update the public and providers about the interim findings they receive.   This is clearly responsible and an action that we've failed to see out of the pharmaceutical industry in timely fashion.

Simvastatin is sold as a single-ingredient generic medication and as the brand-name Zocor. It also is sold in combination with ezetimibe as Vytorin, and in combination with niacin as Simcor.

FDA’s review of new information on the risk of muscle injury is derived from multiple sources, including clinical trials and studies and reports of all types.  Kudos to the FDA for looking out for the public.  

However, with the known complaints and controversy surrounding the drug for years, you might ask why is it in 2010 that we're getting such a stern warning?  Part of the answer is that it takes years to get meaningful data in order to draw accurate conclusions.  That's just one of the inherent limitations of the scientific method. 

In reality, without putting a drug on the market until it has been "perfected" companies run the risk of losing market share.  They balance this problem by justifying that the drugs, although potentially harmful, do indeed save lives by preventing cardiac events.