A couple from Missouri is alleging Onglyza heart failure in a recent product liability lawsuit filed against Bristol Myers Squibb and AstraZeneca Pharmaceuticals.

The couple claims the type-2 diabetes medication carried dangerous side effects but the pharmaceutical companies failed to warn them causing one of the claimants to develop heart failure.

Plaintiff Stuart N. and wife Canice N. filed this Onglyza lawsuit together, claiming the long lasting consequences of the drug’s side effects have permanently impacted their quality of life. The couple says Stuart was prescribed Onglyza in February 2011 for typical type-2 diabetes treatment . Stuart says he was told the drug was supposed to help manage diabetic symptoms in conjunction with diet and exercise.

Onglyza (Saxagliption) is part of the incretin mimetic drug family, which works by signaling the pancreas to make more insulin to help regular blood sugar levels in patients. Without sufficient insulin levels, patients could develop potentially fatal conditions like ketoacidosis or kidney failure.

Incretin mimetics are relatively new in the United States market, but have come under intense scrutiny after fellow popular treatment drug Avandia was recalled due to an increased risk of cardiac death.

According to the Onglyza lawsuit, Stuart and his prescribing doctors were unaware of a potentially increased risk of cardiac complications and had taken the medication according to prescription instructions. As a result, Stuart reportedly developed congestive heart failure and was diagnosed with the condition in March 2014.

Stuart and Canice opted to file legal action against the companies soon after his diagnosis after discovering there had been official warnings about potential Onglyza heart failure.

Overview of Onglyza and Heart Failure

According to advocacy group diaTribe, an advisory committee to the FDA had urged the agency to require Bristol Myers and AstraZeneca to include increased risk of heart failure on Onglyza’s warning label in April 2015, after reviewing the SAVOR clinical trials.

The SAVOR study was published in the New England Journal of Medicine in 2013. The study consisted of 16,492 type-2 diabetes patients that were prescribed different treatment medications.

The purpose of this study was to help doctors evaluate these treatment drugs, but were concerned when Onglyza patients reportedly experienced a slightly increased risk of heart failure. According to the results, Onglyza patients faced a slightly higher likelihood of hospitalization for heart failure compared to other patients.

More specifically, 3.5 percent of Onglyza patients had to be hospitalized for heart failure compared to the 2.8 percent of the placebo group. For comparison, this would be the equivalent of 35 out of 1,000 patients, compared to 28 out of 1,000. Other risk factors researchers noted were pre-existing heart failure or kidney impairment.

The FDA released another announcement in April 2016, stating a safety review had found that type-2 diabetes medications containing saxagliptin and alogliptin could increase the risk of heart failure, painful in patients who already have heart or kidney disease. Patients who experience any symptoms of heart failure, like shortness of breath or fatigue, should contact their doctors immediately.

Even though these complications can be devastating to patients, Bristol Myers and AstraZeneca allegedly failed to disclose this information to the public. At all times relevant, Stuart and Canice say they relied on the information provided by the companies and had no way of discovering the potential risk of Onglyza heart failure.

This Onglyza Lawsuit is Case No. 5:19-cv-00068-KKC, in the U.S. District Court of Eastern Kentucky, Central Division Lexington.