Statins and the New FDA Warnings: What Does It All Mean for Your Patients?

Statins have been shown to significantly reduce the risk of heart attacks, heart disease and death. But this week, the FDA decided that the package inserts of the various statins must now include a warning that these agents may raise blood glucose levels and that they can cause memory loss.

What is the basis for the FDA’s rule, and what is the magnitude of this risk? Should you pause when you next consider writing a statin prescription, or can you reassure your worried patients and go on prescribing with confidence?

Here to put this issue into perspective are Drs Christopher Cannon and Payal Kohli. Dr Cannon, a senior investigator with the TIMI Study Group, is editor-in-chief of Cardiosource Science and Quality. He is also Professor of Medicine at Harvard Medical School and Associate Physician in the Cardiovascular Division of Brigham and Woman’s Hospital in Boston. Dr Kohli graduated from Harvard Medical School and completed her internal medicine training in Boston and is scheduled to start her fellowship in cardiovascular medicine at the University of California San Francisco in June 2012.

Take-home Points

• Patients who take statins have fewer MIs and strokes and need fewer revascularizations. Blood glucose levels increase in a very small percentage of patients who take statins; nevertheless, the benefits of these medications far outweigh the risks.

• Statins confer a significant reduction in ’hard’ clinical events in both the near-term and long-term.

• The FDA’s action serves as a reminder of the need to continue to practice primary prevention and risk factor management. It should not deter clinicians from prescribing these life-saving medications—or patients from taking them.