A Georgia woman has joined the growing list of plaintiffs pursuing Onglyza lawsuits over the drug’s alleged association with heart failure. In a complaint filed on July 24th, in the U.S. District Court, Northern District of Georgia, Cynthia Turner accused AstraZeneca of failing to adequately warn patients about the risks purportedly associated with saxagliptin, the active ingredient in its Onglyza and Kombiglyze XR Type 2 diabetes medications.
According to her complaint, Turner was prescribed saxaglipti-containing drugs from about 2013 to 2014, and subsequently went on to develop heart failure. She claims the condition was the directly related her use of the medications. At the time, the labels for Onglyza and Kombiglyze XR lacked any heart failure warnings, even though AstraZeneca was allegedly aware of data linking saxagliptin to significant adverse events, including heart failure, congestive heart failure, cardiac failure, and death related to those events.
“On information and belief, Plaintiff’s prescribing physicians would not have prescribed Saxagliptin to Plaintiff, would have changed the way in which they treated Plaintiff’s relevant conditions, changed the way they warned Plaintiff about the signs and symptoms of serious adverse effects of Saxagliptin, and discussed with Plaintiff the true risks of heart failure, congestive heart failure, cardiac failure, and death related to those events, and other serious adverse events had Defendants provided said physicians with an appropriate and adequate warning regarding the risks associated with the use of Saxagliptin,” Turner states in her complaint.
Turner’s Onglyza lawsuit seeks damages for bodily and mental injuries, pain and suffering, mental anguish, disfigurement, embarrassment, inconvenience, loss of earnings and earning capacity, and past and future medical expenses.
The U.S. Food & Drug Administration (FDA) approved Onglyza in 2009 to treat Type 2 diabetes. Kombiglyze XR (saxagliptin and metformin) was approved in 2010.
Five years after approving Onglyza, the FDA launched a review of all saxagliptin-containing drugs after interim data from a large clinical trial called SAVOR-TMI indicated that patients treated with the medication were 27% more likely to be hospitalized for heart failure compared to those who were not. Saxagliptin also appeared to be associated with a higher risk of all-cause mortality.
A year later, the agency’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) overwhelmingly voted to recommend that the prescribing information for Onglyza and other saxagliptin-containing drugs be modified to warn of a potential heart failure risk. The FDA announced label modifications for Onglyza and Kombglyze XR (saxagliptin and metformin) in April 2016.
In May 2017, the National Law Journal reported that up to 200 product liability claims had been filed in U.S. courts on behalf of patients who suffered serious cardiac problems allegedly related to treatment with Onglyza and Kombiglyze XR. An attorney interviewed for the report speculated that the litigation involving saxagliptin medications could eventually grow to include thousands of similar lawsuits.