Statins get new safety warnings

By Shari Roan/Los Angeles Times

Statins are among the most popular prescription medications in the country, used by millions of people to lower cholesterol. But they can cause rare side effects - a problem the Food and Drug Administration said Tuesday that it cannot ignore.

The agency announced it would require improved safety warning labels on statins to warn of the rare risk of liver damage, memory loss and other cognitive problems and increases in blood sugar that can lead to Type 2 diabetes. Moreover, the drug known as lovastatin (which is known by several brand names, including Mevacor) can cause muscle weakness in rare cases.

The new warnings are not likely to cause doctors to pull their patients off the medications. Many questions remain about how rare these risks actually are and whether they are more common after many years of use or in certain individuals.

The agency eased up on one warning associated with statins. The labels will no longer advise doctors to routinely monitor liver enzymes of patients taking statins. The updated wording on the label will state that liver enzyme tests should be performed when a patient first begins taking statins and when indicated thereafter.

The main intent of the label change is to inform consumers of any risks associated with the drugs, according to the FDA.