FDA adds diabetes to statins warning
The US FDA has warned that some widely used cholesterol-lowering drugs, also known as statins, could raise blood sugar levels and cause memory loss. Accordingly, the FDA has announced safety changes to the labelling for these drugs. Doctors in India say the new warnings are crucial as statins are widely used drugs.
Statins have been shown to significantly reduce the risk of heart attack and heart disease. However, according to the FDA release, “memory loss, confusion and increase in blood sugar levels have been reported following use of the drug”. Experts said the risk factors go away once the drug is discontinued. The FDA has recommended that statins carry a warning about the increase in blood sugar levels.
The FDA also stated that there could be no serious liver injury following the use of statins in patients. It has been suggested that “patients taking statins will no longer need routine periodic monitoring of liver enzymes”.
Dr Anoop Misra, chairman, Fortis, Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology, said: “It is very important for physicians to keep these warnings in mind and check blood sugar repeatedly in persons who are on statin drugs.” He added: “Indians are prone to diabetes anyway.” However, the FDA also argues that the cardiovascular benefits of statins outweigh these increased risks. “The value of statins in preventing heart disease has been clearly established. Their benefit is indisputable, but they need to be taken with care and knowledge of their side-effects,” read a statement from Amy Egan, deputy director for safety in the FDA’s division of metabolism and endocrinology products.
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