The U.S. Food and Drug Administration (FDA) announced on February 28th that the prescribing information for cholesterol reducing drugs in the statin class will include information about post-marketing reports of reversible memory loss, forgetfulness, and confusion.
Drugs in the statin class include:
Combination products that contain statins include:
The FDA arrived at this decision after reviewing post-marketing adverse events reports, published case reports, observational studies, and clinical studies. Adverse events reports described individuals over 50 years old who experienced memory loss or impairment one day to years after starting statin therapy. Symptoms reversed within a few weeks (median 3 weeks) after stopping the statin. Cases were not associated with Alzheimer's or other chronic conditions that affect brain function. There was no correlation with the type of statin, statin dose, age of the individual, or other medications used by the individuals. Observational studies and clinical trials reviewed by the FDA did not suggest that statins have any significant effect on brain function. Some earlier small statin studies suggested that statins may improve memory function or improve Alzheimer's. However, results of the Pravastatin (Pravachol) and cognitive function in the elderly study (PROSPER) showed no benefit or adverse effect of pravastatin on brain function.
What does this all mean
Trompet S, van Vliet P, de Craen AJ, et al. Pravastatin and cognitive function in the elderly. Results of the PROSPER study. J Neurol. 2010;257:85-90.
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