FDA Announces New Warning Labels for Cholesterol Drug
(WASHINGTON) — Federal regulators announced on Tuesday they would add additional safety warnings to the labels on statins, a class of drugs that lower cholesterol.
Statins — more commonly known by the brand names Lipitor, Crestor and Zocor — inhibit the enzyme that plays a big part in the liver’s production of cholesterol.
The U.S. Food and Drug Administration now requires that statin labels include warnings about the rare, but serious risk of liver damage, memory loss and confusion along with type 2 diabetes. Certain statins, known by the generic name lovastatin, can raise the risk of muscle weakness.
The decision came following an internal meeting between the FDA’s Office of Surveillance and Epidemiology and Office of New Drugs, according to Dr. Amy Egan, the FDA’s deputy director of safety in the division of metabolism drug products.
Egan said most of the information reviewed, especially the effect of statins on memory loss, came from a small number anecdotal reports compiled over one year. She added that the warning for memory loss was more for serious cognitive problems than simple forgetfulness.
“We can’t establish causality with statin therapy,” said Egan, regarding the new warnings.
Most of the studies the division evaluated were short-term studies, suggesting that the long-term effects of statin therapy were unclear. Egan also said it had yet to be determined which statins and at what dose could increase the risk of the listed side effects.
Many experts said the added labels should not deter patients from statins. Instead, they should report any side effects they experience to their physician.
Consumers will be able to see the label changes on their medications within the next 30 days, Egan said.
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