Onglyza Heart Attack, Heart Failure Lawsuit Filed Over Diabetes Drug

The side effects of Onglyza allegedly caused a Georgia man to suffer a heart attack and develop congestive heart failure, after using the diabetes drug for less than two years. 

In a product liability complaint (PDF) filed in the U.S. District Court for the District of Georgia on October 25, John Wesley Hunt, Sr. indicates that Bristol-Myers Squibb, AstraZeneca and McKesson Corporation failed to adequately warn about the heart risks associated with saxagliptin, which is the active ingredient in Onglyza and Kombiglyze XR

Hunt indicates that he ingested the saxagliptin from about September 2015 until April 2017, alleging that it caused him to suffer a myocardial infarction and congestive heart failure.

Onglyza (saxagliptin) was developed jointly by AstraZeneca and Bristol Myers Squibb, and introduced in 2009 for treatment of type 2 diabetes. Kombiglyze XR is a long-acting version of Onglyza combined with metformin, another front-line diabetes drug.

Although the medications have been marketed as safe and effective, concerns have emerged in recent years about the heart risks Onglyza and Kombiglyze XR, resulting in stronger warnings being required by the FDA last year.

When Hunt used the diabetes drug, he indicates that the manufacturers were not providing adequate warnings for consumers and the medical community, despite the findings of its own studies, and recommendations of an FDA advisory board, which suggested that a heart attack warning be added to the label. It also notes that there were better diabetes drugs that Hunt could have chosen had accurate and complete information been provided.

“In addition to Defendants refusing and failing to warn of the risks of heart failure, congestive heart failure, cardiac failure and death, Defendants’ Saxagliptin drugs lack any benefit sufficient to tolerate the risks posed by its use because other anti-diabetes drugs are available that do not carry the increased cardiac risks of Saxagliptin,” the lawsuit states. “Defendants, with knowledge of the true relationship between use of Saxagliptin and myocardial infarction, heart failure, congestive heart failure, cardiac failure, and death related to those events, promoted and continue to promote Saxagliptin as a safe and effective treatment for type 2 diabetes mellitus.”

The FDA first launched an investigation into the potential heart risks with Onglyza in 2014, following the publication of the SAVOR study by the New England Journal of Medicine in 2013.

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.

The FDA now recommends that health care professionals should consider a different medication if an individual develops heart failure on Onglyza or Kombiglyze XR.

Hunt’s claim joins a growing number of Onglyza lawsuits filed by individuals nationwide who say they developed heart failure or other health problems due to the lack of adequate warnings on the diabetes drug.