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FDA’s Recent Statin Label Revision

FDA’s Recent Statin Label Revision

  • The Food and Drug Administration (FDA) announced a revision of statin labels. Changes made include:
  • removal of the recommendation for routine monitoring of liver enzymes(baseline only needed and then prn)
  • new info about reversible cognitive adverse effects reports of blood glucose and HgA1C levels.
  • new contraindications and dose limitations with statin concurrent use with certain meds which risk for myopathy and/or rhabdomyolysis.

More at: http://www.fda.gov/Drugs/DrugSafety/ucm293101.htm