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FDA to review heart failure risk associated with saxagliptin
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The FDA requested additional clinical trial data for saxagliptin due to potential heart failure risks, according to an announcement released today.
Concerns arose after data cited an increased rate of hospitalization for heart failure when patients were administered saxagliptin (Onglyza/Kombiglyze XR, AstraZeneca) compared with placebo; this data, which the FDA considers “preliminary,” was published in the New England Journal of Medicine in September, according to the release.
Patients in the saxagliptin group were hospitalized for heart failure more than patients in the placebo group (3.5% vs. 2.8%; HR=1.27; 95% CI, 1.07-1.51), according to the published data.
Although the study did not find increased rates of death or other major CV risks, including heart attack or stroke in patients who were administered the type 2 diabetes drug, the FDA has requested that the manufacturer submit trial data to the agency by early March 2014.
The FDA plans to conduct an analysis of the data as a “broader evaluation of all type 2 diabetes drug therapies and cardiovascular risk,” according to the press release.
The agency recommends that health care providers continue to follow prescribing recommendations on the drug label until more information becomes available. Any side effects should be reported to the FDA MedWatch program.
For more information:
FDA Drug Safety Communication on saxagliptin.
Scirica BM. N Engl J Med. 2013; 369:1317-1326.