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Statins & Memory Loss Warning Label

Darrell Hulisz, RPh, PharmD

October 2, 2013

The FDA recently approved new label changes regarding safety formation for HMG-Co-A inhibitors ("statins"). Changes include additional informationregarding adverse events as well as drug interactions. A particular adverse event is the potential effect of statins on memory loss. The FDA addeda warning to all statin labels that their use may be associated with memory loss, increased confusion, and forgetfulness.1

Data reported to the FDA stated that patients report feeling unfocused or 'fuzzy.' Symptoms were reversible within a few weeks of discontinuingthe medication. There were no clear timeframe for onset of symptoms. Some patients experience symptoms within a day or two of taking the medication,while others have been taking the medication for several years before symptoms occur.2

There is conflicting data showing the link between statins and memory loss. While there is data supporting memory loss with the use of statins, there is neurological protective data as well. In a longitudinal, observational study of healthy patients = 75 years old, statin use was associated with reduced risk of dementia.3

Conversely, survey results from a group of 171 patients showed 75% (128 patients) reported an adverse drug reaction regardingcognitive function. It is thought that because cholesterol is a necessary part of neuronal function, the inhibition of cholesterol synthesis would cause a decline in cognitive function.4

The benefit of statin therapy is clearly defined. However, the medication should be taken with proper monitoring. Adverse consequences oncardiovascular health may be greater upon discontinuation of statins when used for secondary prevention compared to risks of memory loss.Randomized prospective studies are needed to fully delineate the effects of statins on memory.

1. FDA expands advice on statin risks. U.S. Food and Drug Administration. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm293330.htm
Accessed September 21, 2013

2. FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs. U.S. Food and Drug Administration. http://www.fda.gov/Drugs/DrugSafety/ucm293101.htm
Accessed September 21, 2013.

3. Bettermann K, Arnold AM, Williamson J, et al. Statins, risk of dementia, and cognitive function: secondary analysis of the Ginkgo Evaluation of Memory Study. J Stroke Cerebrovasc Dis. 2012;21(6):436-444

4. Evans MA, Golomb BA. Statin-associated adverse cognitive effects: survey results from 171 patients. Pharmacotherapy. 2009;29:800-811.

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