Bristol-Myers Squibb and Astrazeneca are facing a lawsuit after a woman allegedly died of Onglyza heart failure.

According to plaintiff Shirley W., Louvenia G. took Onglyza (saxagliptin) from May 2010 through October 2016 to treat blood sugar fluctuations caused by type-2 diabetes. She allegedly developed Onglyza heart failure in June 2012, which resulted in hospitalization, extensive treatment and her death on May 19, 2017.

Onglyza belongs to a class of medications known as incretin mimetics that act by stimulating the pancreas to produce insulin. Avandia was the first incretin mimetic on the market, but it was recalled after it was linked to an increased risk of heart-related death.

Onglyza and Kombiglyze both contain saxagliptin, which has now also been linked to a possible increased risk of heart failure, according to a safety communication released by the FDA in February 2014.

Onglyza Heart Failure Studies

In April 2015, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee looked at two large clinical trials consisting of patients with heart disease. More patients taking Onglyza were hospitalized for heart failure when compared with a control number of patients who were given a placebo.

The study reported a total of 35 out of 1,000 patients taking Onglyza were hospitalized, compared to 28 out of 1,000 who took the placebo.

Onglyza works by altering the natural incretin hormone cycle, an action that potentially causes increased risks of cardiovascular-related adverse events, according to the Ongylza heart failure lawsuit.

Bristol-Myers Squibb and Astrazeneca are accused of failing to perform studies or to adequately warn doctors and patients that Onglyza heart failure could develop, potentially leading to hospitalization and death related to those conditions.

The Onglyza heart failure lawsuit alleges that the drug companies promoted Onglyza “to doctors, clinics, and users as being safer than (or as safe as) other drugs for the treatment of Type 2 diabetes mellitus.”

The lawsuit further alleges that if Louvenia had known the risks of serious cardiovascular problems, she would have not taken Onglyza to treat her diabetic condition.

The conduct of Bristol-Myers Squibb and Astrazeneca “was extremely reprehensible” in a variety of ways, alleges the Onglyza heart failure complaint, because “it was going on for a substantial length of time” and “it was committed with knowledge that it was causing or was likely to cause harm,” according to the lawsuit.

By allegedly misrepresenting Onglyza heart failure risks, plaintiffs claim the drug companies effectively concealed the dangerous and potentially life-threatening adverse effects the drug could cause.

Because Onglyza was marketed as a safe, effective, well-tolerated, and adequately tested medication that did not increase the risk of any serious cardiovascular issues, Louvenia’s doctor and Louvenia herself allegedly felt Onglyza was an appropriate medication for her blood sugar control.

Louvenia’s family seeks compensation for wrongful death, emotional distress, medical expenses, consequential damages, restitution and other expenses.

The Onglyza Heart Failure Lawsuit is Case No. 5:18-cv-00373-KKC in the U.S. District Court for the Southern District of West Virginia, Charleston Division.