Study questions FDA warning over adverse cognitive effects of statins

The US Food and Drug Administration (FDA) has approved brexpiprazole (Otsuka Pharmaceutical’s Rexulti) for the treatment of adults with schizophrenia. In the image, Building 66 of the FDA

In 2012, the US Food and Drug Administration (FDA) warned that statins could adversely impact cognition. According to the FDA, the cognitive symptoms – including forgetfulness, amnesia, memory impairment and confusion – tended to be mild and reversible upon statin discontinuation.

The validity of the FDA warning has now been called into question by results of a systematic review and meta-analysis published in the Journal of General Internal Medicine (online, 10 January 2015)[1]
. In 25 placebo-controlled trials involving nearly 47,000 patients, adverse cognitive outcomes attributable to statins were rarely reported.

Furthermore, meta-analysis of cognitive test data from 14 studies, with nearly 28,000 participants, found no significant effect of statins on any aspect of cognition in either cognitively normal individuals or in those with Alzheimer’s disease.




[1] Ott BR, Daiello LA, Dahabreh IJ et al. Do statins impair cognition? A systematic review and meta-analysis of randomized controlled trials. Journal of General Internal Medicine 2015. doi: 10.1007/s11606-014-3115-3.

Last updated
The Pharmaceutical Journal, PJ, 31 January 2015, Vol 294, No 7847;294(7847):DOI:10.1211/PJ.2015.20067676

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