Onglyza Heart Attack Lawsuit Filed Over Failure to Warn About Cardiac Risks

According to allegations raised in a product liability lawsuit filed this month against Bristol-Myers Squibb and AstraZeneca, side effects of Onglyza caused a Kentucky man to suffer a heart attack months after he began using the diabetes drug.

The complaint (PDF) was filed in the U.S. District Court for the Eastern District of Kentucky on July 13, by David Taylor and his wife, Leatha, indicating that the drug makers failed to adequately warn about the risks associated with Onglyza.

Taylor indicates that he began taking Onglyza in April 2015, and continued to use the diabetes drug through June 2015. In July 2015, he suffered a myocardial infarction, or heart attack, which has left him with permanent injuries and adverse effects.

The lawsuit claims that the manufacturers knew about risk of heart problems associated with Onglyza, but failed to warn consumers or the medical community, and actively withheld information about the drug’s side effects.

“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, including Plaintiff David Taylor, his physicians, and other healthcare providers,” the lawsuit states. “These concerted efforts resulted in significant harm to those terated with Saxagliptin, including patients.”

Onglyza (saxagliptin) was developed jointly by AstraZeneca and Bristol-Myers Squibb, but is now owned wholly by AstraZeneca. It was approved by the FDA in July 2009, for treatment of type 2 diabetes and generated more than $700 million in sales in 2012.

In recent years, concerns have emerged about a heart failure risk with Onglyza, leading the FDA to require new safety warnings in April 2016.

The FDA initially launched a safety review into the Onglyza heart risks in February 2014, following publication of a study in the New England Journal of Medicine, known as “SAVOR”, which found an increased rate of hospitalization due to heart failure among Onglyza users compared to those given a placebo.

In April 2015, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 to recommend stronger warnings about the potential Onglyza heart risks, after a review of data from clinical trials suggested that users may face a higher than expected risk of hospitalization for heart failure and all-cause mortality.

The review looked at two large clinical trials involving patients with heart disease. In both trials, patients given drugs containing saxagliptin or alogliptin were at a higher risk of being hospitalized for heart failure than those given a placebo.

On April 5, the FDA issued a drug safety communication, announcing that new heart failure warnings will required for the diabetes drugs Onglyza, Kombiglyze XR, Nesina, Kazano, and Oseni, which are part of a class of medications known as dipeptidyl peptidase-4 (DPP-4) inhibitors.