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Adverse drug reaction

Study questions FDA warning over adverse cognitive effects of statins

Recent study on adverse cognitive outcomes attributable to statins questions the validity of the US Food and Drug Administration's (FDA) warning on the effects of statins. In the image, building 66 of the FDA

Source: Wikimedia Commons

The US Food and Drug Administration warned in 2012 that statins could adversely impact cognition

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.

 

 

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20067676

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  • Study on adverse cognitive outcomes attributable to statins questions the validity of the US Food and Drug Administration's (FDA) warning on the effects of statins. In the image, building 66 of the FDA

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