Saxagliptin Heart Failure and Death Lawsuits Filed

Santa Clara, CAThe diabetes drug saxagliptin is the subject of 14 lawsuits filed this week in New Jersey, alleging it raises the risk of heart failure. Lawyers for the plaintiffs estimate there are between 150 and 200 saxagliptin cases are pending nationwide, and may, ultimately, reach into the thousands. While most of the cases filed to date are brought by plaintiffs who have congestive heart failure or other cardiac symptoms, a handful of cases were brought on behalf of saxagliptin users who died.

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.

The suits, which are virtually identical, claim AstraZeneca Pharmaceuticals and Bristol-Myers Squibb began selling saxagliptin in 2009 without having done clinical trials first, as required by the FDA, to determine if saxagliptin increases cardiac risk in patients. The FDA had issued a bulletin in 2008 advising diabetes developers of the need to demonstrate their products don't increase such risks.

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.