Friday, May 7, 2010

FDA safety changes Caduet - snapshots

  • Use of atorvastatin with fibric acid derivatives, erythromycin, clarithromycin, a combination of ritonavir with saquinavir or lopinavir, immunosuppressive drugs, azole antifungals, or lipid-modifying doses of niacin can increase the risk for myopathy. The dose of atorvastatin should not exceed 10 mg daily when taking cyclosporine, and caution is advised with doses higher than 20 mg daily when receiving treatment with clarithromycin, itraconazole, or HIV protease inhibitors.
  • Atorvastatin is linked to a dose-dependent risk for liver enzyme elevations and may resolve with dose reduction, drug interruption, or discontinuation of therapy. Liver function tests should be performed before and 12 weeks after both initiation of therapy and dose increases, and periodically thereafter. Dose reduction or dose discontinuation is advised for persistent elevations greater than 3 times the upper limit of normal.

The FDA has added a section to the prescribing information for amlodipine/atorvastatin tablets to advise of the potential increased risk for hemorrhagic stroke in atorvastatin-treated patients with a recent history of stroke or transient ischemic attack.

Data from a post hoc analysis of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) study (n = 4731) showed that use of 80-mg atorvastatin daily was linked to an increased incidence of hemorrhagic stroke relative to placebo in patients without coronary heart disease but who had a stroke or transient ischemic attack within the preceding 6 month.

The FDA also warned that atorvastatin is contraindicated in women who are or may become pregnant. Because of the potential for atorvastatin secretion into breast milk and the attendant risk for serious adverse events in nursing infants, women taking amlodipine/atorvastatin therapy should not breast-feed their infants.

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