American Diabetes Association Statement on Recent FDA Safety Changes in Labeling For Some Cholesterol-lowering Drugs
Yesterday, the U.S. Food and Drug Administration (FDA) announced safety changes in the labeling for some cholesterol-lowering drugs (statins). According to the FDA’s safety announcement, the products include: Lipitor, Lescol, Mevacor, Altoprev, Livalo, Pravachol, Crestor and Zocor. Combination products include: Advicor, Simcor, and Vytorin.
In a statement, the FDA said, “Increases in blood sugar levels (hyperglycemia) have been reported with statin use. The FDA is also aware of studies showing that patients being treated with statins may have a small increased risk of increased blood sugar levels and of being diagnosed with type 2 diabetes mellitus.”
While there is evidence that statins can increase the risk of diabetes, the American Diabetes Association urges people with diabetes who are currently taking a statin to continue their medication unless instructed otherwise by their healthcare provider. Stopping these medications may increase the risk of diabetes-related heart attacks. “Every drug has its risks and benefits, and with statins the risk is small and can be managed,” said Vivian Fonseca, MD, President, Medicine & Science, American Diabetes Association. He adds, “On the other hand, people with diabetes, can receive great benefit from taking these medications. They’ve been proven to prevent heart attacks and prolong life.”
It is important to be aware of the risks and benefits of any medication. Patients with concerns or questions about their statin medication, or any other medication, should ask their physician, pharmacist, or other members of their health care team for more information. The American Diabetes Association continues to support the FDA in its role as the regulatory agency that makes decisions regarding drug safety and efficacy.
The American Diabetes Association is leading the fight to Stop Diabetes and its deadly consequences and fighting for those affected by diabetes. The Association funds research to prevent, cure and manage diabetes; delivers services to hundreds of communities; provides objective and credible information; and gives voice to those denied their rights because of diabetes. Founded in 1940, our mission is to prevent and cure diabetes and to improve the lives of all people affected by diabetes. For more information please call the American Diabetes Association at 1-800-DIABETES (1-800-342-2383) or visit www.diabetes.org. Information from both these sources is available in English and Spanish.