Oct 15, 2023

Onglyza FDA Warning: Diabetes Drug Could Increase Heart Failure Risk

onglyza fda warning

Diabetes drugs such as AstraZeneca's Onglyza could increase patients’ risk of heart failure, according to a U.S. Food and Drug Administration drug safety communication released Tuesday. 

The FDA announced that drugs such as Onglyza — which contains saxagliptin and is used with diet and exercise to lower blood sugar in adults with type 2 diabetes — could increase the likelihood of heart failure, especially in patients already suffering from heart or kidney disease. The FDA’s statement calls for adding new warnings to the drug labels about this safety issue.

The SAVOR Study

The FDA came to its conclusion on Onglyza after reviewing a 2013 study published in the New England Journal of Medicine. The Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR) trial followed more than 16,000 patients with type 2 diabetes and a high risk of cardiovascular disease.

The study found that 3.5% of patients who took Onglyza were hospitalized for heart failure compared to 2.8% in the placebo group.

Symptoms of Heart Failure

As part of their announcement, the FDA advised patients currently taking Onglyza to contact their physician immediately if they begin developing symptoms of heart failure such as:

  • Unusual shortness of breath during daily activities
  • Trouble breathing when lying down
  • Tiredness, weakness, or fatigue
  • Weight gain with swelling in the ankles, feet, legs, or stomach

The FDA further recommends that patients do not stop taking Onglyza until they consult their doctor.

A Troubled History

The FDA’s decision comes nearly a year after the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted to add new labeling information to Onglyza. The committee’s decision was based on the findings of the same study that prompted the FDA’s announcement Tuesday.

This is also not the first time Onglyza has been linked to increased risk of disease for patients taking the drug.

Previously, a study presented at the 2015 World Diabetes Conference revealed that patients taking Onglyza, and other medications in the DPP- 4 inhibitors class of drugs, ran a higher risk of developing acute pancreatitis.

If you or someone you love has a history of heart disease, or think you’ve developed heart problems from taking Onglyza, you may be entitled to compensation. Contact our product liability attorneys for a free, no obligation case evaluation to find out if you have grounds for a claim today.