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 postmarketing reports of reversible memory loss, forgetfulness, and confusion.

Drugs in the statin class include:

• Lipitor (atorvastatin)
• Lescol (fluvastatin)
• Mevacor (lovastatin)
• Altoprev (lovastatin extended-release)
• Livalo (pitavastatin)
• Pravachol (pravastatin)
• Crestor (rosuvastatin)
• Zocor (simvastatin)

Combination products that contain statins include:

• Advicor (lovastatin/niacin extended-release)
• Simcor (simvastatin/niacin extended-release)
• Vytorin (simvastatin/ezetimibe)

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, the 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

• There is no need to panic. Statins have been used for many years by millions of people and the available data does not show that statins cause memory loss or confusion.
• The goal of the FDA was to inform the public that there are rare reports of people taking statins who developed memory loss and confusion. However, the data does not show that statins actually cause memory loss or confusion.
• Clinical trials designed to evaluate the effect of statins on brain function did not show that statins affect brain function.
• Patients should report adverse effects to their healthcare provider, including any persistent change in thinking or ability to complete mental tasks.
• There are several classes of drugs that may cause confusion (e.g., H2-Blockers). Healthcare providers evaluate side effects and adjust therapy as needed.
• The benefit of statins on preventing heart attacks, strokes, and death outweigh an association with reversible memory loss or confusion.

References:

FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs.

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.

Related Article:

Statins and Risk of Increased Blood Glucose Levels and Diabetes