New Alerts on the Side Effects of Statins
Federal health officials have created new safety alert information for statins, the cholesterol-reducing medications, citing rare risks of memory loss, diabetes and muscle pain. Statins are among the most widely prescribed drugs in the world.
For the first time, the Food and Drug Administration has officially linked statin use with cognitive issues, such as forgetfulness and confusion. Many patients have reported these problems for years. Among the drugs affected are Lipitor, Zocor, Crestor and Vytorin.
In 2011, almost 21 million patients in the United States received prescriptions for statins. Whether that number of users is excessive or not has been the subject of much professional debate. While factors like age, family history and blood pressure are taken into account when prescribing statins, some experts have suggested that those with total cholesterol levels around 240 would benefit from treatment.
Statins are cloaked with a wide amount of test data that questions their overall safety and the amount of negative side effects they can cause to the body with a wide range of possible negative side effects. They are commonly prescribed drugs that can help to lower your cholesterol. They work by blocking a substance your body needs to make cholesterol. They work by preventing formation of cholesterol in the liver. Statins are effective at lowering the bad cholesterol (LDL), but have only some effect on lowering blood fats (triglycerides) and elevating good cholesterol (HDL).
Dr. Sidney M. Wolfe, director of Public Citizen’s health research group, is among those who contend statins are overused. He said the new alerts about risks provided more reasons that otherwise healthy people with moderately high cholesterol levels "should not be taking these drugs.”
The F.D.A. said that routine monitoring of liver enzymes in the blood, once considered standard procedure for statin users, was no longer needed because the liver injury associated with statin therapy was so rare.
Reports about memory loss, forgetfulness and confusion occur in all statin drugs and in all age groups of patients, according to the F.D.A.
Officials in the F.D.A. debated whether such reports were truly worrisome. However, in recent years, the F.D.A. — often criticized for waiting too long to issue some safety alerts — has become more willing to be public about possible drug risks, even when the evidence is uncertain.
Statins appear to increase blood sugar levels in some patients by small amounts, and when millions are treated, that change leads to an increase in diagnosis of diabetes.
The F.D.A. had already placed an alert about diabetes risks on the label of Crestor, a big-selling statin made by AstraZeneca, because a Crestor trial showed an increased risk. The agency decided to extend that alert to all drugs in the class with the exception of Pravachol, an older medicine manufactured by Bristol-Myers Squibb.
It has long been known that statins can cause muscle pain, particularly at high doses. In its new alert, the F.D.A. reminded doctors that when taken with some other medications, the statins can linger in the body for a longer period than normal and increase the risk of muscle pain. Among the drugs that conflict with statins are H.I.V. protease inhibitors like telaprevir and boceprevir and the antibiotics erythromycin and clarithromycin.
Sometimes, a rash or flushing may develop after you begin taking a statin. If you take both statins and niacin, you're more likely to have this side effect. Taking aspirin before taking your statin medication may help, but first talk to your doctor.
Most of those who use statins will have little or no side effects, but some may be at a higher risk than others. Risk factors include:
• Taking multiple cholesterol medications
• Women
• Smaller body frame
• Age 65 or older
• Having kidney or liver disease
• Having type I or II diabetes
Statins help many people keep healthier cholesterol levels. Many will instead choose more natural solutions.
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