Cedars-Sinai Medical Center

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CME Newsletter - February 2014


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FDA Eyes Saxagliptin Risk; Victrelis Label Changed

Pharmacy Focus

The U.S. Food and Drug Administration has requested clinical trial data from the manufacturer of saxagliptin to investigate a possible association between use of the Type 2 diabetes drug and heart failure. In addition, the FDA said the label of the hepatitis C drug Victrelis (boceprevir) has been updated to include information about serious reported cases of pancytopenia.

The FDA's request regarding saxagliptin resulted from a study published in the New England Journal of Medicine, which reported an increased rate of hospitalization for heart failure with use of saxagliptin (marketed as Onglyza and Kombiglyze XR) compared to an inactive treatment.

The study did not find increased rates of death or other major cardiovascular risks, including heart attack or stroke, in patients who received saxagliptin. The manufacturer is expected to submit the trial data to FDA by early March.

At this time, the FDA considers information from the study to be preliminary. Analysis of the saxagliptin clinical trial data is part of a broader evaluation of all Type 2 diabetes drug therapies and cardiovascular risk.

The FDA says patients should not stop taking saxagliptin.

To learn more, visit this FDA Web page.

Changes Made to Victrelis Label

The FDA said the label of the hepatitis C drug Victrelis has been updated to include information about serious cases of pancytopenia that have been reported in patients receiving Victrelis in combination with peginterferon alfa and ribavirin. Complete blood counts (with white blood cell differential counts) should be obtained at pretreatment and at treatment weeks two, four, eight and 12, the FDA said. Blood counts should be monitored closely at other times, as clinically appropriate.

The label also was updated to include the risk of agranulocytosis, thrombocytopenia, pneumonia and sepsis.

Separately, the FDA approved an update to the Victrelis label to include a new virologic futility rule: If a patient has HCV-RNA results greater than or equal to 1,000 IU/mL at treatment week eight, then discontinue the three-medicine regimen.

Discontinuation of therapy is recommended in all patients with any of the following:

  • HCV-RNA levels of at least 1,000 IU per mL at treatment week eight
  • HCV-RNA levels of at least 100 IU per mL at treatment week 12
  • Confirmed detectable HCV-RNA levels at treatment week 24

The complete revised label can be viewed here.