Sold under the names Onglyza and Kombiglyze XR, the lawsuits contend that AstraZeneca Pharmaceuticals and Bristol-Myers Squibb, who make and market the drug, failed to warn patients that taking the medication can cause congestive heart failure, cardiac arrest and death.
Plaintiffs filed the lawsuits following an announcement by the US Food and Drug Administration (FDA) that it would require stronger warnings regarding the potential for heart problems on the saxagliptin labeling.
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According to the suits, in 2015 an FDA committee recommended the agency require the addition of a heart failure warning on the label for saxagliptin after reviewing the defendants' own internal study finding a significant increase in the risk of being hospitalized for heart failure. In 2016, the FDA announced that users of saxagliptin have an increased risk of heart failure, and requiring a revised warning label on the drug.
The plaintiffs claim AstraZeneca and Bristol-Myers Squibb were aware of the cardiac risks associated with saxagliptin but failed to notify doctors or consumers.