The Food and Drug Administration (FDA) added new safety warnings to cholesterol-reducing statin drugs on Wednesday, noting increased risks of Type 2 diabetes and memory loss for patients who take the medications.
The changes to the prescribing information apply to the class of statins, including many popularly prescribed drugs such as Lipitor (atorvastatin), Crestor (rosuvastatin), Zocor (simvastatin) and Vytorin (simvastatin/ezetimibe). The new warnings are based on results from the latest clinical trials and reports of adverse events from patients, physicians and drugmakers.
The FDA said that statins may increase users’ risk of brain-related effects like memory loss and confusion. The reports have generally not been serious, however, and the symptoms go away once the drug is stopped, the agency said.
Statins’ labels will now also warn patients and doctors that the drugs may cause a small increase in blood sugar levels and Type 2 diabetes — an effect that has been shown previously in studies. Type 2 diabetes can further increase the risk of heart disease.
In addition, the FDA made a label change specific to Mevacor (lovastatin). Mevacor can interact with other drugs, increasing the risk for muscle pain and weakness, another side effect that has previously been associated with high-dose statin use. Other drugs may raise such risks by increasing the amount of statins in the blood, and the FDA warned that Mevacor should not be taken with protease inhibitors, which are used to treat HIV, certain antibiotics and some anti-fungal medications.
At the same time, the statins’ labeling will no longer require the routine monitoring of patients’ liver enzymes, which was originally intended to alert doctors if the medications were becoming toxic and starting to damage the liver. The FDA concluded that such serious damage is rare, and regular testing for all users isn’t necessary. The agency now recommends that liver enzyme tests be performed before starting statin therapy, and as clinically indicated thereafter.
Despite the new safety warnings, the agency said patients should not be scared off statins. “The value of statins in preventing heart disease has been clearly established,” said Dr. Amy G. Egan, deputy director for safety in the FDA’s division of metabolism and endocrinology products, in an agency statement. “Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects.”
But some experts worried that the labeling changes would result in unnecessarily alarming patients and causing some who may benefit to shy away. “I do not believe there is enough hard evidence to justify information and warnings about memory loss and confusion or increase in blood sugar,” Dr. Scott Grundy of the University of Texas Southwestern Medical Center told MedPage Today. “I also think that these warnings will cause some people who need statins to stop taking them. That would be unfortunate.”
In general, however, experts tended to support the FDA’s action, noting that while the potential diabetes and cognitive side effects were rare, they should still be highlighted to doctors and patients. “These are reasonable and prudent recommendations,” Dr. Steven Nissen of the Cleveland Clinic also told MedPage Today. “I am pleased that FDA did not overstate the diabetes and cognitive function risks. Both problems are uncommon and don’t diminish the importance of statins in cardiovascular protection. For the vast majority of patients, the benefits far outweigh the risks.”
Dr. Gordon Tomaselli, president of the American Heart Association noted people concerned about their cholesterol levels should always focus on prevention through lifestyle changes first, trying drug treatment only if their physicians recommend it. “As with all therapies, the decision to use statins for primary or secondary prevention must include careful consideration of the risks and benefits, side effects and cost,” Tomaselli said in a statement. “The FDA’s announcement on the label changes does not question the benefit of statins to lowering cholesterol, but it does provide patients and healthcare providers the most current information about the safe use of statins.”