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U.S. Department of Health and Human Services

Drugs

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September 12: Why did it take Lipitor going off patent for the FDA to add a "memory problems" warning to statins? Where are Phase IV studies on statins?

CDER Director

FDA has been investigating reports of cognitive impairment or memory issues from statin use for several years. The Agency has reviewed databases that record reports of bad reactions to drugs and statin clinical trials that included assessments of cognitive function.

The reports about memory loss, forgetfulness, and confusion span all statin products and all age groups. Although rare, patients affected often report feeling “fuzzy” or unfocused in their thinking. In general, the symptoms were not serious and were reversible within a few weeks after the patient stopped using the statin. Some people affected in this way had been taking the medicine for a day; others had been taking it for years.

For some, this risk is offset by the important function statins perform. When diet and exercise are not enough to reduce cholesterol to goal levels, doctors often prescribe statins. By interfering with the production of cholesterol, statin medications can slow the formation of plaque in the arteries. With less cholesterol in the bloodstream, there is a reduced risk of high-cholesterol-related diseases.

We approved label changes for statins in March 2012 to provide the public with information about the safe and effective use of statins. The labels were updated to outline the potential for nonserious and reversible side effects, which include memory loss and confusion.