FDA Demands New Warnings on Statins

The FDA today announced the release of new safety guidelines for labeling across a range of popular statins, which are a class of drug often prescribed in an effort to lower cholesterol.

The new guidelines mean that manufacturers will need to enhance their safety information to include the following:

  • Cognitive effects, including memory loss and confusion
  • Increase in blood sugar levels
  • Increased risk of diabetes mellitus
  • Risk for muscle injury

Contrarily, the FDA revised labeling guidelines related to monitoring of liver enzymes. In a reversal of previous guidance, the FDA now recommends that “liver enzyme tests should be performed before starting statin therapy, and as clinically indicated thereafter.” Prior guidance urged health care providers to continually and routinely monitor liver enzymes to quickly detect any serious liver precipitated by the statin therapy.

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