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Now statin labeling to have warnings on risk of diabetes - FDA recommends

Statins can raise blood sugar and glycosylated hemoglobin HbA1c levels, according to a new labeling change approved by the Food and Drug Administration (FDA) for the entire drug class of statins

The labeling will now state that statin therapy should not be restarted if the drugs cannot be ruled out as a cause of the problems.

This recommendation was based on the recent studies of popular statins showing a significant increase in the risk of diabetes mellitus associated with high-dose statin therapy. A 27% increase in diabetes mellitus in patients taking rosuvastatin compared to placebo was demonstrated by the Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) trial. Also, worsening of glycemic control by high-dose atorvastatin was shown in the Pravastatin or Atorvastatin Evaluation and Infection Therapy: Thrombolysis In Myocardial Infarction 22 (PROVE-IT TIMI 22) substudy.

The FDA approved the labeling changes to also include new information on the potential for usually minor and reversible cognitive side effects. Moreover lovastatin label has been significantly updated to provide information on contraindications and dose limitations for the drug as it may increase the risk for muscle injury in patients taking other medicines that lovastatin.

Additionally, the recommendation that patients on statins undergo routine periodic monitoring of liver enzymes is now eliminated by the FDA because this approach was ineffective in detecting and preventing the "rare and unpredictable" serious liver injuries related to statins. However, statin therapy in situations where the patient shows signs of serious liver injury, hyperbilirubinemia, or jaundice should be interrupted.

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