Medications in the "statin" (HMG-CoA reductase inhibitors) class are used by millions of patients and their benefits for reducing cholesterol and preventing heart attacks are well known. Statins are prescribed for individuals with high cholesterol as well as patients with mildly elevated cholesterol and have other risk factors for heart attacks such as diabetes, hypertension, previous stroke, or previous heart attack. Statins have been available in the U.S. for over 20 years. Therefore, the recent announcement from the U.S. Food and Drug Administration (FDA) that the package insert for these popular drugs will include information about post-marketing reports of reversible memory loss, forgetfulness, and confusion alarmed many patients and healthcare providers. This not the first time that the effect of statins on brain function has been evaluated. Earlier small statin studies suggested that statins may actually improve brain function but more robust scientific studies did not support this theory.
The FDA reviewed post-marketing adverse events reports, published case reports, observational studies, and clinical studies to decide whether statins cause memory loss. Post-marketing adverse events cases of memory loss included people over 50 years of age with memory loss or impairment with onset from one day to years after starting a statin, and duration of a few weeks (median 3 weeks) after stopping the statin. Age, type or dose of statin, or other medications used did not correlate with the occurrence of memory loss. Available observational and clinical studies suggest that statins do not have significant effect on brain function.
The available evidence does not show that statins affect brain function. The FDA's goal was to tell the public that there are post-marketing reports of memory loss or confusion associated with statin use. Post-marketing reports are not evidence of cause and effect because there are other possible explanations for the memory loss. Patients should not panic because statins have been used for many years and available data does not show that statins cause memory loss or confusion. Moreover, there are many drugs that are proven to affect brain function but are still used because their benefits are greater than their risk. The benefits of statins on preventing stroke, heart attack, or death far outweigh the very small risk, if any, of reversible effects on cognitive brain function. Patients should report adverse effects, including confusion and persistent change in memory, to their healthcare provider.
Drugs in the statin class:
- Lipitor (atorvastatin)
- Crestor (rosuvastatin)
- Livalo (pitavastatin)
- Pravachol (pravastatin)
- Zocor (simvastatin)
- Lescol (fluvastatin)
- Mevacor (lovastatin)
- Altoprev (lovastatin extended-release)
- Vytorin (simvastatin/ezetimibe)
- Advicor (lovastatin/niacin extended-release)
- Simcor (simvastatin/niacin extended-release