New FDA Warning: 2 Common Diabetes Drugs May Put Your Heart at Risk

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New FDA Warning Two Diabetes Drugs May Put Your Heart at Risk FA2

The US Food and Drug Administration (FDA) recently issued a new alert regarding the safety of two drugs taken for type 2 diabetes—saxagliptin and alogliptin (sold as Onglyza by AstraZeneca and Nesina by Takeda, respectfully).

The FDA made this announcement based on new findings that these two drugs have the potential to increase the risk of heart failure.

Internal Safety Review Uncovers Risks

The new FDA alert stems from an internal safety review that the organization performed on the heels of two large patient trials focused on cardiovascular outcomes among patients with cardiovascular disease. Specifically, the review was initiated by two studies that were first presented at the European Society of Cardiology (ESC) meeting in 2013 and later appeared in the New England Journal of Medicine. Based on an FDA panel’s concerns from this review, and the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee’s recommendation for the drugs’ labels to be revised, the agency went forward with the alert.

One of the two studies assessed saxagliptin by analyzing the health outcomes of 16,492 patients with type 2 diabetes who either had cardiovascular disease or were at a heightened risk for the disease. While this study did not find an overall risk for cardiovascular events, it did identify a 27% increase in the rate of hospitalization for heart failure, as well as a potentially increased risk for mortality.

Meanwhile, the second study examined the safety of alogliptin by focusing on a comparison of the drug against a placebo. Among the 5,380 patients in the study, the researchers found a slight increase in hospitalization on the drug as compared to a placebo, although the difference was not statistically significant.

What is the Warning?

As a result of the internal review, the labels of these two dipeptidyl peptidase–4 (DPP–4) inhibitor drugs will be modified. The new labels will include warnings that the drugs may increase the risk for heart failure, especially among patients who already have cardiovascular disease or kidney disease. Furthermore, an FDA statement on the matter cautioned that “healthcare professionals should consider discontinuing medications containing saxagliptin and alogliptin in patients who develop heart failure and monitor their diabetes control.”

The statement went on to warn that “if a patient’s blood sugar level is not well-controlled with their current treatment, other diabetes medicines may be required.” Lastly, the FDA confirmed that combination products that contain the two agents are also affected by the warning, which includes saxagliptin and metformin extended release, alogliptin and metformin, and alogliptin and pioglitazone (which are marketed as Kombiglyze XR by AstraZeneca, Kazano by Takeda, and Oseni by Takeda, respectively).

Talk to Your Doctor

If you are currently taking one of the noted medications, it is important that you talk to your physician about the drug immediately, and may want to discontinue use of the drug altogether. Among other things, there may be better medicinal alternatives for controlling type 2 diabetes available.

In addition, it is important to consider controlling your diabetes naturally to the greatest degree possible. More and more research is being conducted on this topic, and it is a good idea to stay up to date on these studies. For example, recent research has identified many natural solutions, such as cinnamon, berberine, curcumin, and even sleep. Consider integrating these types of natural solutions into your efforts to control your diabetes, and be cautious of the potential side effects of medication.


Derek Noland Derek is a technical writer and editor with 10 years of experience in the health care field, having first earned a Bachelor of Arts in English from the University of Delaware. He is a contributing author on a number of textbooks in the medical field, ran a nuclear cardiology licensing course, and has written a variety of other pieces from online training courses to medical software manuals. Derek pursues his personal interest in health and wellness by playing multiple sports and running marathons. An insatiable traveler, he spent 16 months working and living abroad while traveling through South America, Europe, and Southeast Asia.


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