Harvard Health Letter

Changes to the statin label: What they really mean

Statins

The FDA has made changes to the safety label for statins, the cholesterol-lowering drugs that over 20 million Americans take in hopes of reducing their chances of having a heart attack or stroke. When the changes were announced in February 2012, it reignited a smoldering debate about the benefits and risks of statins.

If you want our bottom line, here it is: the vast majority of people taking statins should continue to take them, but some additional attention to blood sugar levels is warranted. And, as with any medication, if you're taking a statin and experience side effects, you shouldn't hesitate to contact your doctor.

Interested in more details? Read on.

Increases in blood sugar levels

The safety information for statins now says that increases in HbA1C and fasting serum glucose levels have been reported. HbA1C is a blood test that reflects average blood sugar levels; serum glucose is just another way of saying blood sugar.

The warning doesn't mention diabetes, but that is, of course, the concern if blood sugar stays high. An important meta-analysis published in 2010 in The Lancet concluded that taking a statin increased the chance of developing diabetes by 9%. More proof came last year with the publication of a smaller meta-analysis of higher doses of statins taken with more ambitious LDL-cholesterol–lowering goals in mind. Not surprisingly, "intensive" statin therapy was associated with a higher (12%) risk of developing diabetes.

To continue reading this article, you must login.
  • Research health conditions
  • Check your symptoms
  • Prepare for a doctor's visit or test
  • Find the best treatments and procedures for you
  • Explore options for better nutrition and exercise
Learn more about the many benefits and features of joining Harvard Health Online »