Onglyza Lawsuit Claims AstraZeneca Failed to Warn on Heart Failure Risk

Published on March 10, 2017 by Laurie Villanueva

A new Onglyza lawsuit has been filed in the U.S. District Court, Southern District of Texas, by a man who developed heart failure following treatment with the Type 2 diabetes drug. In a complaint entered with the Court on February 1st, the Plaintiff alleges that he and his doctors were not provided with adequate warnings regarding the cardiac risks associated with saxagliptin.

Saxagliptin is the active ingredient in Onglyza. The medication was developed jointly by AstraZeneca and Bristol-Myers Squibb, but is now wholly-owned by AstraZeneca. Onglyza was approved by the U.S. Food & Drug Administration (FDA) in 2009 to treat Type 2 diabetes. Kombiglyze XR, a long-acting form of saxagliptin coupled with metformin, was approved the following year.

According to the Texas lawsuit, the Plaintiff was prescribed Onglyza and/or Kombiglyze XR in 2010, and continued treatment for about five years. As a result of his exposure to saxagliptin, the Plaintiff claims to have suffered heart failure, congestive heart failure, and acute hypoxic respiratory failure.

“On information and belief, Plaintiffs prescribing physicians would not have  prescribed Saxagliptin to Plaintiff, would have changed the way in which they treated Plaintiff’s relevant conditions, changed the way they warned Plaintiff about the signs and symptoms of serious adverse effects of Saxagliptin, and discussed with Plaintiff the true risks of heart failure, congestive heart failure, cardia failure, and death related to those events, and other serious  adverse events had Defendants provided said physicians with an appropriate and adequate warning regarding the risks associated with the use of Saxagliptin,” the complaint states.

FDA Onglyza Warnings

In 2014, the FDA launched a review of saxagliptin, after data from the SAVOR-TMI clinical trial indicated that patients using the drug were 27% more likely to be hospitalized for heart failure compared to those who were not. Saxagliptin also appeared to be associated with a higher risk of all-cause mortality. In April 2015, the agency’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 14-to-1 to recommend that new information regarding a potential association with heart failure be included on the labels for Onglyza and Kombiglyze XR.

In April 2016, the FDA announced that information about a possible increased risk of heart failure would be added to the labels of Onglyza and other saxagliptin-containing medicines. Similar warnings were added to the labels of Type 2 diabetes drugs that contain alogliptin, including Nesina, Kazano and Oseni. The FDA has advised patients taking these drugs to contact their doctor if they develop signs and 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

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