January 28, 2015
FDA Concerns About Statins-Cognitive Issues Link May
Be Unwarranted

Providence, RI—Since 2012, the FDA has required that labels on statin packaging warn that the drugs could affect users’ cognitive abilities.

A new study calls into question, however, the FDA’s warnings that the cholesterol-reducing medications can affect memory, attention span, and other cognitive abilities, based on surveillance and case reports, observational studies, and randomized trials. A systematic review of 25 clinical trials involving nearly 47,000 patients was published recently in the Journal of General Internal Medicine.

With some later studies casting doubts on the FDA’s concerns, a team led by Brian R. Ott, MD, director of The Alzheimer's Disease & Memory Disorders Center at Rhode Island Hospital and professor at the Alpert Medical School of Brown University, sought to perform a more comprehensive analysis.

For the review, researchers scrutinized the data in the 25 relevant randomized clinical trials that investigated a possible link between statin therapy and mental ability. In addition, they combined the results of 14 of these studies into a meta-analysis, which included 27,643 participants in total.

No significant effect on mental capacity—either in subjects with normal brain function or those with Alzheimer’s disease—was found with use of statins, leading study authors to suggest that the FDA’s statin warning should be re-evaluated.

“Statin therapy was not associated with cognitive impairment in RCTs. These results raise questions regarding the continued merit of the FDA warning about potential adverse effects of statins on cognition,” they write.

Ott also urged more research on why the review results differed so much from the initial reports on which the FDA warning was based. He questioned whether some of the mental changes reported in the case studies were due to statin overdose.

The review findings are in line with a 2013 safety statement from the American College of Cardiology and the American Heart Association Cholesterol Guideline, which advise that patients on statins who seem to be confused or who might have memory problems should be evaluated for causes other than their cholesterol medication.

Ott argued that the benefits of statins outweigh worries about the possible adverse mental effects of these drugs.

“We found no significant effects of statin treatment on cognition,” he said. “Given these results, it is questionable whether the FDA class warning about potential cognitive adverse effects of statins is still warranted.”

U.S. Pharmacist Social Connect