Researchers Challenge FDA Warning That Statins Affect Cognition

the Neurology Advisor take:

A group of researchers are challenging the FDA’s warning that statins impair cognitive function and memory in people who take the drugs to control hypertension.

The warning, which has been in effect since 2012, warns that statins can affect abilities like attention span, problem solving, memory, language, and visuospatial abilities, and was based on the results of surveillance, case reports, studies and trials.

However, none of those symptoms were apparent in a systematic review of 25 clinical trials that followed nearly 47,000 people.

"We found no significant effects of statin treatment on cognition," said Brian R. Ott, MD, director of The Alzheimer’s Disease & Memory Disorders Center at Rhode Island Hospital, and author of the review. "Given these results, it is questionable whether the FDA class warning about potential cognitive adverse effects of statins is still warranted."

The review involved a data analysis of 25 randomized clinical trials that investigated a possible link between statin use and mental ability. The researchers also performed a meta-analysis of 14 of those studies. There was no effect of statin use on cognition and memory in people with both normal brain health and those with Alzheimer’s.

The researchers suspect that the original data from which the FDA’s warning is based off of could have been the result of statin overdose.