A Georgia man has filed a new Onglyza lawsuit, after he suffered a heart attack and developed heart failure that he claims were caused by the Type 2 diabetes medication.
According to a complaint filed in the U.S. District Court, District of Georgia, on October 25th, John Wesley Hunt, Sr. took saxagliptin (the active ingredient in Onglyza and Kombiglyze XR) from approximately September 2015 to April 2017. (Case No. 5:17-cv-00419-CAR)
Hunt alleges that his use of the medication led to adverse health effects, including myocardia infarction and congestive heart failure, as well as his hospitalization on November 13, 2015 and January 2016.
The lawsuit charges that AstraZeneca and other defendants were aware of the dangerous side effects allegedly associated with saxagliptin — including myocardial infarction, heart failure, congestive heart failure, cardiac failure, and death related to those events — but failed to provide doctors and patients with adequate warnings of these risks.
“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 myocardial infarction, 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 states.
Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin and metformin) are indicated to treat adults suffering from Type 2 diabetes. Onglyza was approved by the U.S. Food & Drug Administration in 2009, while Kombiglyze XR was cleared the following year.
The labels for both drugs were modified in April 2016 to include information about a possible risk of heart failure, after interim data from a 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.
Dozens of plaintiffs who suffered adverse cardiac side effects allegedly related to Onglyza or Kombiglyze XR have filed suit against the drug’s manufacturers in courts throughout the country.
In October, a group of these plaintiffs asked the U.S. Judicial Panel on Multidistrict Litigation (JPML) seeking to centralize all such federal claims in the U.S. District Court, Northern District of California, arguing that the cases would benefit from coordinated discovery and other pretrial proceedings.
The JPML is expected to take up the matter at its January 2018 Hearing Session.