FDA issues warning on statins

The FDA has raised concerns about the popular cholesterol-fighting drugs, saying the risk of diabetes should be added to the drug's warnings and precautions. NBC's Robert Bazell reports.

The Food and Drug Administration announced Tuesday that people who take popular cholesterol-lowering drugs called statins may have an increased risk of raised blood sugar levels and could also be at greater risk of getting Type 2 diabetes. In addition, some people who take statins have reported memory impairment.  

Statins, some of the most-prescribed drugs on the market, are taken by millions of Americans.

In a statement, the FDA noted the benefits of taking the drugs often outweigh the risks.

“The value of statins in preventing heart disease has been clearly established,” said Amy G. Egan, M.D., M.PH., deputy director for safety in FDA’s Division of Metabolism and Endocrinology Products. “Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects.”

The FDA will be modifying the drug package insert found in the following statin products to include the federal safety agency's new concerns:

  • Altoprev (lovastatin extended-release)
  • Crestor (rosuvastatin)
  • Lescol (fluvastatin)
  • Lipitor (atorvastatin)
  • Livalo (pitavastatin)
  • Mevacor (lovastatin)
  • Pravachol (pravastatin)
  • Zocor (simvastatin).

Products containing statins in combination with other drugs include:

  • Advicor (lovastatin/niacin extended-release)
  • Simcor (simvastatin/niacin extended-release)
  • Vytorin (simvastatin/ezetimibe).

Click here to visit the FDA's website and learn more.

Discuss this post

Statins are not safe, and contrary to what Mr. Bazell stated this evening, there IS a question as to how much benefit these types of drugs offer to anyone except a very tiny percentage of men who have already been diagnosed with heart disease. Cholesterol has never been proved to cause heart disease and so lowering cholesterol levels does not prevent heart disease. Do some research, please.

  • 1 vote
Reply#1 - Tue Feb 28, 2012 7:02 PM EST

This is not a balanced story. The REAL BIG NEWS is that after thirty years of statin labels carrying a label which required physicians to measure liver function tests on a periodic basis, the FDA has removed this requirement. In doing this, the FDA quoted several lines of evidence that prove that statins do not appear to cause liver problems. At the same time as removing this warning which affects everyone taking statins, the FDA added warnings about certain rare and reversible side effects. It is not clear that these side effects are due to statins or whether they just occur in the same type of patients that take statins. In adding the warning about statins having a small effect on blood sugar which leads to an increase in patients being diagnosed with diabetes, the FDA stated that it is clear the benefits outweigh the risks. This kind of statement can be made because statins are the most studied class of drugs today having been studied in double blind, long term studies in over 170,000 patients as a recent meta anlysis by Dr Rory Collins has described. Kathy-1256709 appears to be entirely ignorant of this fact.

    Reply#2 - Tue Feb 28, 2012 10:00 PM EST

    Cheerios works better than Lipitor without the bad side effects. You have my word. And no prescription is

    needed, a no brainer, but good luck finding a doctor who will admit it. Hey, whatever works, right?

      Reply#3 - Thu Mar 1, 2012 11:04 AM EST
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