FDA approves new safety labeling for statins

By Professor Juan Tamargo, Madrid, Spain

The US Food and Drug Administration (FDA) approved a new labeling indicating that taking a statin can raise blood sugar and glycosylated hemoglobin HbA1c levels. This new labelling is valid for all statins.

The diabetes warning came from two recent trials. The JUPITER (Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin) trial showed a 27% increase in new-onset diabetes in patients randomized to rosuvastatin, despite the enrolled patients who had no history of cardiovascular disease. Interestingly to mention that based on the JUPITER results, the FD approved rosuvastatin for primary prevention.

The PROVE-IT TIMI 22 (Pravastatin or Atorvastatin Evaluation and Infection Therapy: Thrombolysis In Myocardial Infarction 22) substudy showed that atorvastatin (40 mg/daily) can worsen glycemic control. Furthermore, a meta-analysis of data from 13 statin trials “reported that statin therapy was associated with a 9% increased risk for incident diabetes.”

The new labeling also included:

1) new information on the potential for usually minor and reversible cognitive side effects. This is based on post-marcketing adverse-events reported inindividuals over the age of 50 years who experienced notable, but ill-defined memory loss or impairment reversible upon discontinuation of statin therapy.

2) A list of including 10 drugs that are contraindicated with this lovastatin because they may increase the risk for muscle injury: antifungals (itraconazole, ketoconazole, posaconazole), macrolide antibiotics (clarithromycin, erythromycin, telithromycin), HIV protease inhibitors, boceprevir, telaprevir and nefazodone. Moreover, the new lovastatin label states that cyclosporine and gemfibrozil should be “avoided” when taking lovastatin, and lovastatin dosing should be limited to 20 mg for patients taking danazol, diltiazem, or verapamil, and to 40 mg in those taking amiodaorne.

3) The FDA removed the present requirement for routine periodic monitoring of liver function tests, as this approach is ineffective in detecting and preventing the “rare and unpredictable” serious liver damage related to statins. Thus, clinicians should now simply order a liver function test before starting a patient on a statin. treatment should be interrupted if the patient shows signs of serious liver injury, hyperbilirubinemia, or jaundice. now state.

Despite all these additional warnings, the FDA said it “continues to believe that the cardiovascular benefits of statins outweigh these small increased risks.”