Early last week, the US Food and Drug Administration (FDA) announced their addition of warning labels on statins, a group of cholesterol lowering drugs. The action comes on the heels of the agency’s review of medical literature, clinical trial data, and reports of adverse events leading to increased levels of blood sugar and potential memory loss.

The FDA will be implementing changes to the safety information on the labels of statins such as AstraZeneca’s Crestor, Merck & Co.’s Zocor, and Pfizer Inc’s Lipitor—of which tens of millions of people are consumers.

“The value of statins in preventing heart disease has been clearly established,” Amy Egan, deputy director for safety in FDA’s Division of Metabolism and Endocrinology Products, said in a statement. “Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects.”

Cholesterol-lowering statin therapy is both beneficial and cost-effective for a wide range of the population. They have been shown to significantly reduce the risk of heart attack and heart disease. Thus, the FDA says the new information should not “scare people into stopping taking the drugs.”

“These are nuances, tiny little tweaks to the label, and the bigger picture doesn’t change, says Steven Nissen, chief of cardiology at Cleveland Clinic. “There are few drugs that have saved as many lives as statins and we don’t want to throw the baby out with the bathwater here. If you have heart disease, you probably should be on a statin. If you’re at high risk, a statin may be warranted. But we don’t think these drugs should be put in the water supply,” Nissen says.

So why the sudden change of heart? “I wouldn’t point to any one thing,” said FDA spokeswoman Erica Jefferson when asked about what prompted the label changes. “We’ve been looking at all the information for some time. It’s part of our ongoing surveillance.”

The FDA said it was aware of studies in which some patients taking statins may have a small increased risk of higher blood sugar levels and of being diagnosed with type 2 diabetes, as well as reports of certain cognitive effects such as memory loss and confusion experienced by some patients taking the drugs, the agency said. It said those reports generally have not been serious and the symptoms were reversed by stopping use of the statin.

“We have known for three or four years that statins slightly increase blood sugar,” Nissen reports. “The fact that the blood sugar went up a little bit did not diminish the effectiveness of the statins in reducing (heart) risk for patients.”

The elevated diabetes risk was first noted in a 2008 Crestor study of nearly 18,000 patients. Two years later, a separate study published in the Lancet medical journal found that statins can raise the risk of diabetes by 9 percent.

The memory loss issue was more anecdotal from adverse event reporting and not from formal studies, the FDA said, adding that there was no proof that the problem was caused by statins but that it wanted people to be aware of the possibility.

“I don’t think we should change our practice based on this report,” said Dr. Kenneth Ong, acting chief of cardiology at the Brooklyn Hospital Center in New York. “But the report is a sobering reminder that there’s no such thing as a free lunch. Every drug has its problems and its side effects, despite the benefits.”

Other statins, most of which are available as generics, include Livalo, Mevacor, Pravachol, Altoprev and Lescol. There are also combination medicines that include statins, such as Merck’s Vytorin and Abbott Laboratories’ Simcor.

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