The FDA has requested clinical trial data from AstraZeneca Plc's popular diabetes drug saxagliptin, marketed as Onglyza, to review possible associated heart risks.
The FDA request resulted from data published in the New England Journal of Medicine, which reported an increased rate of hospitalization for heart failure with use of saxagliptin, when compared to an inactive treatment.
The FDA notes that information from the NEJM study is preliminary and 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 FDA recommends that patients continue to take the drug and health care professionals continue to follow the prescribing recommendations
Read the FDA press release