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FDA links Zocor to muscle damage, especially in women

Consumer Reports News: June 10, 2011 03:38 PM

Most people should not take the 80 milligram dose of simvastatin (Zocor, Vytorin, and generic), the U.S. Food and Drug Administration said this week after it found a clear link between that dose and muscle pain as well as rare but potentially deadly muscle damage. Our medical consultants go one step further than the FDA, and say people taking any cholesterol-lowering drug should start at the lowest necessary dose.

The FDA made the announcement after reports to its adverse-events database and a recent clinical trial found that people who took high-dose simvastatin had a substantially greater risk of developing muscle problems. The danger was greater in older women and those who took simvastatin in addition to blood-pressure drugs known as calcium-channel blockers, particularly diltiazem (Cardizem and generic).

People starting drug treatment for elevated cholesterol, as well as those who’ve taken simvastatin for less than a year, should generally begin with or switch to a lower dose, the FDA said. It also said that people who’ve taken the 80 mg dose for 12 months or longer without any muscle problems could likely continue taking the drug. But our medical consultants say even those individuals should consider switching to the 40 mg dose, since the difference in cholesterol lowering between the two is only about 6 percent, according to the FDA.

Indeed, our medical consultants say that most people initiating treatment with any related statin—including atorvastatin (Lipitor), fluvastatin (Lescol and generic), lovastatin (Mevacor, Altoprev and generic), pravastatin (Pravachol and generic), and rosuvastatin (Crestor) —should usually start with the lowest available dose, and increase slowly, if necessary. That’s because all statins cause muscle pain and weakness in at least 5 to 10 percent of people (and perhaps as many as a third). And all pose a slight, but real, risk of triggering rhabdomyolysis, a rare condition that can cause kidney damage, kidney failure, and death.

The only exceptions are people who’ve already had a heart attack or have acute coronary syndrome plus a very high cholesterol level. Research shows those people are often best off with a 40 mg or 80 mg dose of atorvastain (Lipitor), according to our Best Buy Drugs Report on statins.

The FDA also warned about taking simvastatin with certain other drugs. Notably, it issued new limits for people taking simvastatin along with several heart medications:

• No more than 20 mg of simvastatin when taken with amlodipine (Norvasc and generic).
• No more than 10 mg of simvastatin when taken with diltiazem (Cardizem and generic) or verapamil (Verelan and generic).
• No more than 20 mg of simvastatin when taken with amiodarone (Cordarone).
• No more than 20 mg of simvastatin when taken with ranolazine (Ranexa).

Finally, the agency added several drugs to the list of medications that should never be used with simvastatin, including cyclosporine, danazol, gemfibrozil, and pocosaconazole.

Bottom line:
Don’t suddenly stop taking your high-dose statin medication. But do talk to your doctor about possibly lowering the dose, especially if you’re an older woman or take any of the drugs mentioned above. If you‘re taking any statin drug and notice muscle pain, tenderness or weakness, dark or red-colored urine or unexplained tiredness, contact your doctor right away. Take the lowest dose of any statin drug that achieves the desired effect on LDL cholesterol.

New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury [FDA]

Lisa Gill

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