FDA Adds New Safety Information To Statin Drugs

lipitor 55908496 FDA Adds New Safety Information To Statin Drugs

A prescription bottle label of Pfizer's Lipitor. (credit: Tim Boyle/Getty Images)

WASHINGTON (AP) – Federal health officials are adding new safety warnings about risks of memory loss and elevated blood sugar to statins, a widely prescribed group of cholesterol-lowering medications.

The Food and Drug Administration said Tuesday it is making labeling changes to medicines like Pfizer’s Lipitor, AstraZeneca’s Crestor and Merck & Co. Inc.’s Zocor. The drugs are used by tens of millions of U.S. patients to help prevent heart related problems associated with cholesterol.

New labeling on all such drugs will warn of memory loss and confusion reported among certain patients taking statins. The problems were generally not serious and went away after patients stopped taking the drugs, according to the FDA.

The updated labels will also mention elevated levels of blood sugar, associated with diabetes, that have been reported in some patients taking statins. A growing number of studies published over the last five years have found a link between statin use and type 2 diabetes. Last June, a report in the Journal of the American Medical Association analyzed five older randomized trials and concluded the increased risk was small but real for people taking higher doses of any statin.

Statins are mainly prescribed to prevent heart attacks in people with clogged arteries and work by dramatically lowering LDL or “bad cholesterol.” They were the third best-selling drug class in the U.S. for 2010 with sales of $18.8 billion.

In addition to the label additions, the FDA said it will remove a long-standing warning related to liver injury. The drugs label previously recommended routine testing of liver enzymes to avoid injury. The agency now recommends a single test when patients first begin taking statins.

“FDA has concluded that serious liver injury with statins is rare and unpredictable in individual patients, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare side effect,” the agency said in a statement.

In addition to statins, the new labeling changes apply to several combination drugs that mix older statins with newer cholesterol medicines, including Merck’s Vytorin and Abbott Laboratories Simcor.

(© Copyright 2012 The Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten or redistributed.)

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One Comment

  1. susan says:

    now they tell us!! why is it one day something is good for you and the next day it will kill you or has terrible side effects???this doesnt seem to stop doctors from prescribing statin drugs….i quit taking lipitor and my cholesterol, actually went down..tried another rx and iit seems to work better..go figure!….thats like red wine and chocolate are good for your hears, but now they say skip the red wine!!

  2. Jesse_EngAmer says:

    Statins are high-risk drugs. Studies show very few people actually benefit from taking them. But they make money. The FDA has admitted that all the dangerous side effects are real. Then assures the public the threats are not serious. Talk about being in big pharma’s pocket.

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