Safety alert
date: 5/24/2005
Crestor riskier than other cholesterol drugs
The "statins" used to reduce cholesterol are generally very safe, but serious side effects are more likely with Crestor.
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The powerful cholesterol-lowering drug rosuvastatin (Crestor) is more likely than other available statin medicines to cause potentially serious side effects. This is according to a large study in the medical journal Circulation, posted online May 23, 2005. The study reinforces the recommendations Consumer Reports has made about rosuvastatin since soon after it came on the market in late 2003: Most people should avoid rosuvastatin unless other statins that are comparably effective and have longer safety records have been tried first. The new finding underscores the importance of using all cholesterol-lowering medications at the lowest effective dose and only when lifestyle changes alone aren't sufficient.
Researchers at Tufts-New England Medical Center compared the adverse drug events for rosuvastatin reported to the FDA over two 12-month periods to those reported for three other statins over comparable time frames. The absolute rate of adverse events for rosuvastatin--including muscle, kidney, and liver damage--was quite low. But it was about 2 to 9 times higher than the rates for the other statins. The apparent greater risk might be acceptable if rosuvastatin was clearly more effective than other drugs. But its cholesterol-lowering power is only slightly larger than other statins and it's not yet proven to prevent heart attack or premature death.
The new study confirmed that statins, as a class, are extremely safe medicines, and consumers should not avoid or stop taking them because of the current study. But the study adds another reason to use the newest statin, rosuvastatin, only when other medications aren't sufficient, and to use all cholesterol-lowering drugs safely. Specifically:
What's the risk
Researchers at Tufts-New England Medical Center compared the adverse drug events for rosuvastatin reported to the FDA over two 12-month periods to those reported for three other statins over comparable time frames. The absolute rate of adverse events for rosuvastatin--including muscle, kidney, and liver damage--was quite low. But it was about 2 to 9 times higher than the rates for the other statins. The apparent greater risk might be acceptable if rosuvastatin was clearly more effective than other drugs. But its cholesterol-lowering power is only slightly larger than other statins and it's not yet proven to prevent heart attack or premature death.
Recommendations
The new study confirmed that statins, as a class, are extremely safe medicines, and consumers should not avoid or stop taking them because of the current study. But the study adds another reason to use the newest statin, rosuvastatin, only when other medications aren't sufficient, and to use all cholesterol-lowering drugs safely. Specifically:
- Individuals who require just a moderate LDL reduction should undertake lifestyle changes first. If that doesn't adequately lower your LDL level, consider taking generic lovastatin, which has the longest safety record and lowest cost of any statin.
- Those who need larger LDL reductions or have very high coronary risk should generally take the more powerful drug atorvastatin (Lipitor). It costs slightly more than rosuvastatin (Crestor) but has a longer safety record and better evidence of effectiveness. If low to modest doses of Lipitor don't adequately lower your LDL level, consider a higher dose or adding a second drug, such as niacin (Niacor) or ezetimibe (Zetia).
- Regardless which statin you take, use the lowest dose necessary to reach your goal. And watch out for warning signs. Call your doctor immediately if your muscles become achy, tender, or weak, or if your urine is dark brown, all of which may indicate muscle damage that, in rare cases, can fatally damage the kidneys. And have your liver function tested before starting the drug and periodically thereafter. People who drink alcohol heavily or have kidney or liver damage should use statins with special care.
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