A man from Oklahoma has filed an Onglyza heart failure lawsuit accusing AstraZeneca PLC and Bristol-Myers Squibb of concealing dangerous side effects allegedly associated with saxagliptin.
According to his September 1st filing in the U.S. District Court, District of Oklahoma, Carl Hulbert was prescribed Onglyza and Kombiglyze XR on various occasions to treat Type 2 diabetes. He claims that the side effects associated with their active ingredient, saxagliptin, caused him to develop heart failure, congestive heart failure, and cardiovascular injury. Hulbert claims he could have avoided his complications had defendants provided doctors and patients with adequate warnings about the risks potentially associated with saxagliptin.
“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,” the complaint charges.
This Onglyza lawsuit is just the most recent case to be filed against AstraZeneca and Bristol-Myers Squibb. In May, National Law Journal reported that up to 200 lawsuits 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. The report indicated that hundreds of additional Onglyza and Kombiglyze XR lawsuits could be filed in the near future.
The U.S. Food & Drug Administration (FDA) approved Onglyza (saxagliptin) in 2009, while Kombiglyze XR (saxagliptin and metformin) was approved in 2010.
The FDA launched a review of all saxagliptin-containing drugs just five years after approving Onglyza, 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 Kombiglyze XR (saxagliptin and metformin) in April 2016.