Onglyza FDA Warning

The Type 2 diabetes drug Onglyza has been named in a new Food & Drug Administration (FDA) alert regarding a possible association with heart failure. The Onglyza FDA warning cautioned patients to contact their health care provider if they develop any heart failure symptoms while taking the medication.

What is Onglyza?

Onglyza (saxagliptin) is an incretin mimetic used to treat Type 2 diabetes that belongs to a class of medications called DPP-4 inhibitors. Launched in 2009, sales of the drug totaled more than $700 billion in 2011. A related medication, Kombiglyze XR , contains both saxagliptin and metformin.

When it was approved in 2009, the FDA asked Onglyza’s manufacturer to conduct postmarket studies in order to better evaluate its possible heart risks, as well as potential associations with liver toxicity and severe skin reactions. In 2011, the advocacy group Public Citizen warned consumers to avoid Onglyza until 2016, when more information about its possible side effects would be known.

Onglyza FDA Safety Review

In February 2014, the FDA announced that it had launched a safety review of Onglyza and Kombiglyze XR, after the SAVOR-TIMI 53 suggested that patients treated with saxagliptin were 27% more likely to be hospitalized for heart failure compared to those taking a placebo.

In April 2015, the agency convened a meeting of its FDA Endocrinologic and Metabolic Drugs Advisory Committee to discuss the SAVOR-TIMI results. The panel ultimately voted 14-1 to recommend that new information regarding a potential increased risk of heart failure be added to the Onglyza and Kombiglyze XR label

Onglyza Label Updated for Heart Failure

In an Onglyza FDA warning issued on April 5, 2016, the agency announced that new Warnings and Precautions were being added to the labels of saxagliptin-containing medications regarding an increased risk of heart failure. According the FDA, the risk may be highest in patients with pre-existing heart or kidney disease.  Similar changes were made to the labels of Nesina and other diabetes medications that contain alogliptin.

The FDA acted after a review of two large clinical trials found that more patients who received saxagliptin- or alogliptin-containing medicines were hospitalized for heart failure compared to patients who received a placebo. In the saxagliptin study, 3.5% of patients who received the drug were hospitalized for heart failure versus 2.8% of patients who received a placebo. This is the same as 35 out of every 1,000 patients compared to 28 out of every 1,000 patients, the agency said. Read More

Heart failure is a serious medical condition that can result in the heart not being able to pump enough blood to meet the body’s needs. The FDA has warned Onglyza patient to contact their doctor if they develop any of the following symptoms:

  • 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

Legal Assistance for Those Harmed by Onglyza

Bernstein Liebhard LLP offers free legal reviews to Onglyza patients who were diagnosed with heart failure while using this Type 2 diabetes medication. To learn more, please contact our office today by calling (888) 994-5118.

  1. Public Citizen (2011) “Worst Pills, Best Pills: February 2011 Articles”
  2. FDA (2014) “FDA Drug Safety Communication: FDA to review heart failure risk with diabetes drug saxagliptin (marketed as Onglyza and Kombiglyze XR)”
  3. Reuters (2015) “FDA panel backs safety updates for AstraZeneca, Takeda drugs”
  4. FDA (2016) “FDA Drug Safety Communication: FDA adds warnings about heart failure risk to labels of type 2 diabetes medicines containing saxagliptin and alogliptin”
Last Modified: June 28, 2016

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