The Food and Drug Administration (FDA) has added new warnings to the safety labels of cholesterol-lowering medications known as statins to alert users that the drugs carry an increased risk for type 2 diabetes and memory loss. The warnings were applied to popular brand names and their generic equivalents, including Lipitor (atorvastatin), Crestor (rosuvastatin), Zocor (simvastatin) and Vytorin (simvastatin/ezetimibe). The new labels were based on results from the latest clinical trials and reports of adverse events from patients, physicians and drug makers.
The data shows that cognitive (brain-related) impairment, such as memory loss, forgetfulness and confusion, has been reported by some statin users. However, when the medication is discontinued these symptoms generally go away.
The FDA also warned that people being treated with statins may have an increased risk of raised blood sugar levels and the development of type 2 diabetes. Also, that some medications interact with the active ingredient lovastatin (which includes brand names such as Mevacor) and can increase the risk of muscle damage.
But the news wasn’t all bad. The agency recommended that routine monitoring of liver enzymes in the blood, once considered standard procedure for statin users, is no longer needed. Such monitoring has not been found to be effective in predicting or preventing the rare occurrences of serious liver injury associated with statin use.
The FDA urged users of statin drugs not to be alarmed nor take themselves off the medication as these drugs have been shown valuable in the prevention of heart disease. However, patients should be aware of the possible side effects and discuss any concerns with their doctors.
The following statin drugs will now carry the new safety label:
- Altoprev (lovastatin extended-release)
- Crestor (rosuvastatin)
- Lescol (fluvastatin)
- Lipitor (atorvastatin)
- Livalo (pitavastatin)
- Mevacor (lovastatin)
- Pravachol (pravastatin)
- Zocor (simvastatin)
The following products containing statins in combination with other drugs include:
- Advicor (lovastatin/niacin extended-release)
- Simcor (simvastatin/niacin extended-release)
- Vytorin (simvastatin/ezetimibe)