The US Food and Drug Administration has warned that cholesterol-reducing medicines sold by some of the largest drug companies can increase the risk of diabetes and memory loss.
After a rise in reports of side-effects, the FDA is requiring new labelling on drugs such as Pfizer’s Lipitor, AstraZeneca’s Crestor and Merck’s Zocor. Statins reduce levels of “bad” cholesterol in the bloodstream – and generate more than $30bn in annual sales.
“The value of statins in preventing heart disease has been clearly established,” said Amy Egan, deputy director for safety in the FDA’s division of metabolism and endocrinology products. “Their benefit is indisputable, but they need to be taken with care and knowledge of side-effects.”
According to the National Center for Health Statistics, about 25 per cent of Americans over 45 take statins.
The FDA said on Tuesday that statin labels should contain information about the risks of memory loss, confusion and increased blood sugar.
Research last month from the University of Massachusetts Medical School found that women over 50 taking statins had a 48 per cent higher rate of diabetes. Last June, a study in the Journal of the American Medical Association found a higher risk of diabetes in patients taking large doses of statins than in those taking moderate amounts.
“It is imperative that future studies evaluate the risks as well as benefits of statin use among men, women and diverse ethnicities,” said Dr Yunsheng Ma at the Massachusetts school.
In spite of the new risks, some physicians say they continue to value statins.
“Current data suggests that statins directly target one of the biggest risk factors for heart attack and stroke,” said Dr Paulraj Samuel, cardiologist at Albert Einstein Medical Center in New York. “As with all medications, physicians should weigh the risks and benefits, paying close attention to the individual clinical scenario.”
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