The daughter of a woman who died of complications of diabetes has filed an Onglyza lawsuit, alleging that drug led to her mother’s heart failure.

Plaintiff Rochelle G. of Chicago says her mother Lillie began taking Onglyza for diabetes in 2010. By June 2011 Lillie had been diagnosed with heart failure, and she was hospitalized twice for that condition in 2013. She died in October 2013.

Rochelle filed a lawsuit against Onglyza’s manufacturer AstraZeneca, alleging Lillie’s heart failure and death was caused by Onglyza. Among other things, her Onglyza lawsuit seeks awards of punitive damages and reimbursement of her attorneys’ fees and court costs.

Her lawsuit is Case No. 2015-L-010969, in Cook County Circuit Court.

Onglyza is AstraZeneca’s brand name for the drug known generically as saxagliptin. It’s a relatively new diabetes medication first approved by the FDA in 2009.

Onglyza is used both by itself and in combination with other diabetes medications to treat type-2 diabetes. (It is not FDA-approved to treat type-1 diabetes.) The same active ingredient is also used in the diabetes medication Kombiglyze XR.

Onglyza is one of a class of diabetes medications known as DPP-4 inhibitors. These drugs work by suppressing the action of the enzyme dipeptidyl peptidase IV, or DPP-4, allowing incretin hormones to stimulate more production of insulin in the pancreas and to stop the liver from producing glucose – all of which results in a reduction of the amount of sugar in the blood.

DPP-4 inhibitors are particularly useful for controlling the spikes in blood sugar that sometimes occur right after eating a meal.

Recent medical studies have hinted at the possibility of a relationship between Onglyza and heart failure. A study published in The New England Journal of Medicine in October 2013 set out to evaluate the cardiovascular effects of saxagliptin.

It cited evidence in previous studies that showed either no cardiovascular benefit or an increase in the risk of heart failure associated with diabetes medications. While the study found no increase or decrease in ischemic events, it did reveal an increase in the incidence of hospitalization for heart failure in patients with diabetes.

FDA Action on Saxagliptin

Based on the results of that study, in February 2014 the FDA solicited supplemental clinical trial information on saxagliptin from its manufacturers. The agency plans to investigate the possible association between saxagliptin and heart failure.

The FDA specifically advises patients taking saxagliptin not to alter or discontinue their medication without first consulting their physician.

This action is part of the FDA’s ongoing effort to improve the available research about the cardiovascular effects of diabetes medications. Since December 2008, the agency has been actively soliciting evidence from pharmaceutical companies that shows their diabetes medications do not increase the likelihood of cardiovascular events like heart attack.

The agency says that diabetes patients have two to four times the risk of heart disease than do persons without diabetes. Therefore, since treatment for diabetes is often life-long, the agency stepped up its standards for clinical trial design and data collection for diabetes medications.