Statins to carry revised warning labels: FDA

By Dr. Ananya Mandal, MDFeb 29 2012

The U.S. FDA announced today that they would add additional safety warnings to the labels on statins, a class of drugs that lower cholesterol. Statins – with brand names Lipitor, Crestor and Zocor work by inhibiting the enzyme that plays a big part in the liver's production of cholesterol.

According to the announcement, statin labels need to include warnings about the rare but serious risk of liver damage, memory loss and confusion, and type 2 diabetes. Certain statins, known by the generic name lovastatin, can raise the risk of muscle weakness. There was an internal meeting between the FDA's Office of Surveillance and Epidemiology and Office of New Drugs, according to Dr. Amy Egan, the FDA's deputy director of safety in the division of metabolism drug products. The decision was an outcome of that meeting.

“The value of statins in preventing heart disease has been clearly established,” Egan said in a statement. “Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects.”

Egan said most of the information reviewed, especially the effect of statins on memory loss, came from a small number anecdotal reports compiled over one year. She added that the warning for memory loss was more for serious cognitive problems than simple forgetfulness. “We can't establish causality with statin therapy,” she said.

Egan added that the studies had yet to determine which statins and at what dose could increase the risk of the listed side effects. However, many experts said they'd seen these effects in some of their patients.

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.”

Although the need for liver-monitoring tests have also been removed from statin labels - and instead replaced with recommendations to perform liver enzyme tests before starting statin therapy - many experts said they still prescribed these tests for their patients. “I disagree with the notion that you can stop checking for liver function test abnormalities,” said Dr. Andrew Carroll, a physician at the Renaissance Medical Group in Phoenix. Carroll said he saw high liver enzymes in about 5 percent of the patients to whom he prescribed statins, prompting him to recommend they stop taking the medication.

“These are nuances, tiny little tweaks to the label, and the bigger picture doesn't change,” said 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 said.

“This information highlights the importance of being alert to any new symptom that occurs around the time that you have started any new medication, and making sure that we only recommend drugs where there is a chance of a substantial benefit since all drugs have risks,” said Dr. Harlan Krumholz, a cardiologist and associate professor of medicine at Yale University School of Medicine.

“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 there's no such thing as a free lunch,” Ong said. “Every drug has its problems and its side effects, despite the benefits.”

While the risk of the side effects remains low, Egan said larger and longer-term studies need to be completed to understand exactly what type of patients may be at higher risk. “We really don't feel the changes in the drug labels we made today alter the risk status of statins,” Egan told ABC News. “We still think the benefits of the drug outweigh the risks.” Consumers will be able to see the label changes on their medications within the next 30 days, Egan added.

Last year, more than 20 million Americans were taking some form of statin, according to IMS Health.