Regulatory Focus™ > News Articles > FDA Presses BMS to Investigate Association Between Diabetes Drug Onglyza and Heart Failure

FDA Presses BMS to Investigate Association Between Diabetes Drug Onglyza and Heart Failure

Posted 11 February 2014 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) announced Tuesday that it is initiating an investigation into the safety of saxagliptin, a diabetes drug, and its association with heart failure.


Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor, and is marketed under the trade names Onglyza and Kombiglyze XR (saxagliptin and metformin) by Bristol-Myers Squibb (BMS), its manufacturer, and AstraZeneca.

The drugs are FDA-approved as an adjunct to diet and exercise for adults with type 2 diabetes, and have noted adverse reactions including diarrhea, nausea, vomiting, upper respiratory tract infection, urinary tract infection and headache.

Onglyza's prescribing information presently contains no warnings about cardiovascular risks, while Kombiglyze XR's label contains mention of cardiovascular events (shock, acute congestive heart failure and heart attack) in patients who experience lactic acidosis-a condition known to affect diabetics-while on the medication.

New Risks

But in an 11 February 2014 warning, FDA said a recent study published in the New England Journal of Medicine (NEJM) had raised significantly more serious concerns about an elevated risk of heart failure in patients taking saxagliptin-based medications.

The NEJM study, it said, "reported an increased rate of hospitalization for heart failure, when the heart does not pump blood well enough, with use of saxagliptin compared to an inactive treatment."

However, the same study did not find any increased risk of death, stroke or heart attack in patients who received saxagliptin.

"At this time, we consider information from the NEJM study to be preliminary," FDA said in a statement.

All the same, it has asked BMS to investigate the correlation between the drug and the risk of heart failure, and said it expects to have data in hand "by early March 2014, after which we will conduct a thorough analysis and report our findings publicly."

FDA also urged medical professionals to report any side effects involving saxagliptin to it through its MedWatch program.


FDA Statement


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