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FDA Reviews Heart Failure Risk With Diabetes Drug Saxagliptin (Onglyza)
NEJM study prompts request for trial data (February 11)
The FDA has requested clinical trial data from Bristol-Myers Squibb, the manufacturer of saxagliptin (Onglyza), to investigate a possible association between the use of the type-2 diabetes drug and heart failure.
The agency’s request resulted from a study published in the New England Journal of Medicine (NEJM), which reported an increased rate of hospitalization for heart failure with the use of saxagliptin compared with 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.
Bristol-Myers Squibb is expected to submit the trial data to the FDA by early March 2014.
At this time, the FDA considers information from the NEJM study to be preliminary. Its analysis of the saxagliptin clinical trial data is part of a broader evaluation of all type-2 diabetes drug therapies and cardiovascular risk.
According to the FDA, patients should not stop taking saxagliptin, and health care professionals should continue to follow the prescribing recommendations in the drug labels.
Source: FDA; February 11, 2014.