A new Onglyza lawsuit has been filed in Kentucky that accuses Bristol-Myers Squibb and AstraZeneca of concealing the  cardiovascular side effects potentially associated with the Type 2 diabetes medication. According to a complaint filed last month in the U.S. District Court, Western District of Kentucky, the lead plaintiff experienced a heart attack just months after he was initially prescribed the drug.

“Defendants acted in concert with one another in the Commonwealth of Kentucky to fraudulently convey false and misleading information concerning the safety and efficacy of Saxagliptin and Onglyza and to conceal the risks of serious adverse events, including heart failure, congestive heart failure, cardiac failure, death from heart failure and other adverse effects associated with Saxagliptin and Onglyza from the public,” the lawsuit asserts.

According to the complaint, the plaintiff took Onglyza to treat his Type 2 diabetes from April 2015 thru June 2015. He suffered a myocardial infarction in July of that year, and his lawsuit claims that Onglyza was the direct and proximate cause of the heart attack, as well as his resulting permanent injuries and adverse effects.

The plaintiff is seeking damages for strict products liability, negligence, failure to warn, breaches of warranty, violations of the Kentucky Consumer Protection Act, and loss of consortium on behalf of his wife.

Onglyza and the Heart

Concerns regarding the cardiovascular risks potentially associated with Onglyza have been building since October 2013, when a study published in the British Medical Journal suggested that saxagliptin was associated with a 27% increased risk of hospitalization for heart failure. The study, known as the SAVOR-TIMI 53 trial, involved 16,492 diabetics who were randomly assigned Onglyza or a placebo, all of whom had a history of heart disease or had other risk-factors.

The U.S. Food & Drug Administration (FDA) launched an Onglyza safety review in February 2014. In April of the following year, and agency advisory panel overwhelmingly recommended that the drug’s label be modified to reflect the findings from the SAVOR study. The FDA ordered the recommended modifications in April 2016.

Bernstein Liebhard LLP is now offering free legal reviews to Onglyza patients who were diagnosed with heart failure following treatment with this medication. To learn more, please call 877-779-1414 to discuss your case with one of our attorneys.

Published August 1, 2016 by