Update on Statins

Wednesday, February 29, 2012 // Uncategorized

Statins are the most effective class of cholesterol lowering medications.  This class includes popular drugs such as Lipitor (atorvastatin), Zocor (simvistatin) and Crestor (rosuvastatin).  There have been reports of “statin” brain over the years.  The FDA mentions that in their latest safety alerts.  Part of the problem is that sometimes when you get to an age where an elevated cholesterol is of concern you might not be able to remember names quite as well.  If you think that you have some cognitive problems  and you are taking a statin for primary prevention ( you have never had a heart attack) then the risk to stopping it for several months is low.  Reports of an increased risk of diabetes with statins has been going on for several years.  Most experts think that the benefit outweighs the risk, but if the risk of a heart attack is low, why take the risk of diabetes?  The risk of liver damage is something that people have heard about, but is unusual. the FDA lowered the dosing guidelines of Simvistain recently due to concerns about drug interactions and increased risk of muscle inflammation.  Musle inflammation is uncommon, but muscle pain is.

Here is the Journal Watch summary followed by the FDA news relief.

The FDA is making several changes to the labels of statins following a comprehensive review, the agency announced on Tuesday:
Incident diabetes and increased blood glucose are possible with statin use. Several meta-analyses found an increased risk for diabetes (9%–13%) in patients taking statins.
Reversible memory loss and confusion are possible, though rare. The FDA said there is no evidence that these side effects lead to significant cognitive decline later.
Routine monitoring of the liver enzyme alanine aminotransferase is no longer required, although testing before statin initiation and as clinically indicated is still recommended. The agency has concluded that serious liver injury among patients taking statins is rare and cannot be prevented with routine monitoring.
Use of lovastatin is now contraindicated with strong CYP3A4 inhibitors — including itraconazole and erythromycin — to reduce the risk for rhabdomyolysis. Lovastatin’s new label also lists dose limitations and several other drugs to avoid.

Statin Drugs – Drug Safety Communication: Class Labeling Change

AUDIENCE: Cardiology, Family Practice, Patients


ISSUE: FDA has approved important safety label changes for the class of cholesterol-lowering drugs known as statins. The changes include removal of routine monitoring of liver enzymes from drug labels. Information about the potential for generally non-serious and reversible cognitive side effects and reports of increased blood sugar and glycosylated hemoglobin (HbA1c) levels has been added to the statin labels.

The lovastatin label has been extensively updated with new contraindications and dose limitations when it is taken with certain medicines that can increase the risk for muscle injury.

Read the FDA Drug Safety Communication for more information.


BACKGROUND: Statins are a class of prescription drugs used together with diet and exercise to reduce blood levels of low-density lipoprotein (LDL) cholesterol (“bad cholesterol”). Marketed as single-ingredient products, including Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin). Also marketed as combination products, including Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release),and Vytorin (simvastatin/ezetimibe).


RECOMMENDATION: Healthcare professionals should perform liver enzyme tests before initiating statin therapy in patients and as clinically indicated thereafter. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment, therapy should be interrupted. If an alternate etiology is not found, the statin should not be restarted.

Healthcare professionals should follow the recommendations in the lovastatin label regarding drugs that may increase the risk of myopathy/rhabdomyolysis when used with lovastatin.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online:
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[02/28/2012 – Drug Safety Communication2 – FDA]
[02/28/2012 – Consumer Update3 – FDA]


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