FDA Scrutinizes Diabetes Drug Saxagliptin (Onglyza And Kombiglyze) For Heart Failure Risk
The U.S. Food and Drug Administration (FDA) made a drug safety announcement regarding diabetes drug saxagliptin for its possible association with heart failure risks. Saxagliptin is jointly marketed by Astra Zeneca and Bristol Myers as Onglyza and Kombiglyze.
Saxagliptin is used for the treatment of type 2 diabetes, where the body fails to properly use or produce insulin. The drug works by increasing the amount of insulin in the body when the blood sugar is high, usually after the patient takes meals. Onglyza is a dipeptidyl peptidase-4 (DPP4) inhibitor, indicated as an adjunct treatment to proper diet and exercise for the improvement of glycemic control in adults with type 2 diabetes. Kombiglyze is a combination of saxagliptin and metformin with the same indication when treatment with both saxagliptin and metformin is suitable.
The federal agency said it has requested clinical trial data from the drug’s manufacturer for investigation. The request follows the publication of a study in the New England Journal of Medicine (NEJM) drawing attention to the increased rate of hospitalization for heart failure with use of saxagliptin when compared to an inactive treatment. No increase in mortality rates or other major cardiovascular risks including stroke or heart attack were found in patients who took saxagliptin.
The FDA said, “At this time, we consider information from the NEJM study to be preliminary. Our analysis of the saxagliptin clinical trial data is part of a broader evaluation of all type 2 diabetes drug therapies and cardiovascular risk. Patients should not stop taking saxagliptin and should speak with their health care professionals about any questions or concerns. Health care professionals should continue to follow the prescribing recommendations in the drug labels.” However, the FDA encouraged health care professionals and patients to report side effects involving use of saxagliptin.
Bristol-Myers Squibb, which manufactured saxagliptin and co-marketed it with AstraZeneca, is expected to submit the requested trial data to the FDA by early March this year.
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