Changes in Labeling Statin Drugs – What the New FDA Draft Guidance Says

  • By: Staff Editor
  • Date: April 16, 2012
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On Feb 28 2012, the FDA released new draft guidance on safety changes for widely used cholesterol – lowering or statin drugs. These regulations aim to educate, update health care professionals and patients about the health benefits as well as risks associated with these drugs.
The FDA approved vital changes based on review of data mined from evaluation of all statin labels, entry of new interacting drugs on the market, a review of clinical data, post marketing reports and adverse events reported to determine the scope of the problem.
Safety changes in labelling of statin drugs:
New contraindications:
  • The FDA has revised and updated statin drug labels, so as to provide patients with additional information on the safety and efficacy of statins. According to the Agency, the drug labels will contain information about newly added contraindications along with some of earlier listed drugs, when it should not be combined with other drugs, so as to prevent increased risk of muscle injury.
  • Monitoring liver enzymes:
  • The FDA has made necessary changes to these drug labels in order to eliminate the need for routine periodic monitoring of liver enzymes in patients taking statins.
  • Liver enzyme tests should be performed on patients before initiating statin therapy.
  • The Agency stated that irreversible liver damage resulting from statins is exceptionally rare and is likely idiosyncratic in nature. No evidence exists to show that monitoring at intervals for liver enzyme tests is effective in identifying that an individual may develop significant liver injury from ongoing statin therapy.
  • Monitoring at periodic intervals will only help to identify patients with isolated increased liver enzyme levels, which could in turn aid physicians to make necessary changes to ongoing statin therapy.
  • According to the Agency, serious liver injury with statins cannot be predicted in individual patients, and routine monitoring of liver enzymes at periodic intervals may not be sufficient to detect or prevent accompanying side-effects.
Cognitive effects:
  • As certain cognitive (brain-related) effects have been reported with statin use, labels for statin drugs will now include information about some patients experiencing memory loss and confusion.
  • The Agency maintains that data from the observational studies and clinical trials do not suggest that cognitive changes associated with statin use are common or lead to clinically significant cognitive decline. Such reviews do not reveal an association between an adverse event and the specific statin, the age of the individual, the statin dose, or concomitant medication use.
  • The Agency stated that the post-marketing adverse event reports in individuals over the age of 50 years were reversible upon discontinuation of statin therapy and time of onset of such events was found to be highly variable.
Blood sugar levels
  • The labels for statins will now warn healthcare professionals and patients of the potential risk of slightly elevated blood sugar levels and of being diagnosed with Type – 2 Diabetes Mellitus. The labels will also carry a warning related to HbA1c levels (Glycosylated Haemoglobin).
New label recommendations for Lovastatin
  • Health care professionals should take note of the new recommendations in the label for the specific drug – Lovastatin and should be aware that some concomitant medicines (fibrates, erythromyocin, itraconazole, and immunosuppressive drugs such as cyclosporine can increase blood levels of statins and can raise the risk for myopathy) can interact with Lovastatin, thereby increasing the risk for muscle injury. The label of the drug ‘Lovastatin’ has been updated to reflect the drug interactions which may increase the risk of myopathy/rhabdomyolysis when taken along with protease inhibitors.
  • The updated labels also indicate that Lovastatin should not be used with gemfibrozil instead of the 20 mg dosage limitation in the former package insert.
Muscle adverse events
  • The Agency maintains that risks of statin-related muscle adverse events increase significantly with the addition of interacting drugs to a patient’s therapy and not due to statin therapy alone. Patients should contact their healthcare professional in case of any concerns or issues about statins.
  • The Agency confirms the fact that the cardiovascular benefits of statins outweigh the accompanying slight risks or side-effects.
  • The Agency in its review of safety studies related to a statin drug - Rosuvastatin, stated that available data showed no consistent pattern of clinical presentation of renal failure or renal injury which clearly indicates causation by statin group of drugs.
  • The FDA believes that ‘statins’ continue to be the most commonly prescribed class of medications to manage patients with dyslipidemia and are the most effective class at reducing low-density lipoprotein (LDL) cholesterol levels, as well as morbidity and mortality in patients with dyslipidemia.
New agency body to track drug safety issues
  • Healthcare professionals and patients should report any side effects associated with statin use to the Agency.
  • The FDA implemented a new Drug Safety Oversight Board to help identify, track, and oversee the management of important drug safety issues in a timely and independent manner.


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