Popular cholesterol-lowering drugs may cause memory loss, high blood sugar
On February 28, the Food and Drug Administration (FDA) released a safety communication, which reported that the use of statins, the popular cholesterol-lowering drugs, is associated with memory loss, confusion, and elevations in blood glucose (sugar) levels. These cholesterol-lowering medications are widely prescribed in the US to reduce the risk of a cardiovascular event such as a heart attack or stroke.
According to a new Centers for Disease Prevention and Control (CDC) report released on February 17, the use of these medications has skyrocketed between the periods of 1988-1994 and 2005-2008; between those two periods, their usage has increased 10-fold by adults aged 45 and over (from 2% to 25%). Furthermore, in the 65- to 74-year age group, estimates show 50% of men and 35% of women have taken a statin drug in the past 30 days.
The FDA noted that it is requesting labeling changes to medicines such as AstraZeneca’s Crestor, and Merck & Co. Inc.’s Zocor, and Pfizer Inc.’s Lipitor. The new labels warn of memory loss and confusion reported among certain patients taking statins. In general the problems were not serious and went away after patients stopped taking the medications; In addition, the revised labels note elevated levels of blood glucose has been reported in some individuals taking statins. A number of reports published in the past five years have noted a relationship between statin use and type 2 diabetes. For example, last June, a report published in the Journal of the American Medical Association (JAMA) analyzed five randomized trials and concluded that the increased risk was small but real for individuals on higher doses of any statin.
The report notes that it has received “rare post-marketing reports” of cognitive impairment (i.e., memory loss, forgetfulness, amnesia, memory impairment, and confusion) associated with statin use. The FDA noted that the reported symptoms were generally not serious and resolved if the medication was discontinued. The began from one day to years after starting the medication and disappeared after discontinuance in a average time of three weeks.
Other labeling changes include:
Liver Enzymes Monitoring: Labels have been revised to remove the need for routine periodic monitoring of liver enzymes in patients taking statins. The labels now recommend that liver enzyme tests should be performed before starting statin therapy and as clinically indicated thereafter. The FDA has concluded that serious liver injury with statins is rare and unpredictable in individual patients, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing serious liver injury.
Adverse Event Information: Information regarding the potential for generally non-serious and reversible cognitive side effects and reports of increased blood sugar and glycosylated hemoglobin (HbA1c) levels has been added to the statin labels. The FDA continues to believe that the cardiovascular benefits of statins outweigh these small increased risks.
Drug Interactions: The lovastatin label has been extensively updated with new contraindications (situations when the drug should not be taken) and dose limitations when it is taken with certain medicines that can increase the risk for muscle injury.
The FDA noted that healthcare professionals should refer to the drug labels for the latest recommendations for prescribing statins and that patients should contact their healthcare professional if they have any questions or concerns about statins.