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New warnings about statins
6/1/2012
 
The Food and Drug Administration is requiring manufacturers of widely used cholesterol-lowering drugs to add warnings the drugs may raise levels of blood sugar and cause mild memory loss.

The agency said it is aware of studies which have reported some patients taking statins may have a small increased risk of higher blood sugar levels and of being diagnosed with type 2 diabetes. The FDA added reports of memory loss came from anecdotal evidence and the symptoms were reversed after patients stopped using statins.

On the bright side, the agency said patients taking the drugs don’t have to be routinely monitored for liver function. That might encourage some patients to take statins who were previously deterred.

Statins, taken by about 20 million Americans, have had a dramatically favorable impact on patients at risk from heart disease and the new warnings are not expected to alter prescribing patterns. “These are nuances, tiny little tweaks to the label, and the bigger picture doesn’t change,” Steven Nissen, chief of cardiology at Cleveland Clinic told Reuters.

“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,” he said.

Reuters reported that when asked what prompted the label changes, FDA spokeswoman Erica Jefferson said they were based on the agency’s review of medical literature, clinical trial data and reports of adverse events.

“I wouldn’t point to any one thing,” she said. “We’ve been looking at all the information for some time. It’s part of our ongoing surveillance.”

Dr. JoAnn Manson, chief of preventive medicine at Brigham and Women’s Hospital, whose recent research found a link between women’s use of statins and their diabetes risk, also noted the benefits of statins outweigh the risks.

But, she added, “the concern is that an increasingly large number of people at relatively low risk of heart disease are being started on statins at a young age and kept on them for long durations, and it isn’t entirely clear that the net benefits they’re getting are outweighed by the risks,” she noted to the Boston Globe.