On October 25, 2017, a Georgia man filed a new Onglyza lawsuit against manufacturers Bristol-Myers Squibb and AstraZeneca Pharmaceuticals, in the U.S. District Court for the Middle District of Georgia. He claims that after taking Onglyza, which is a type 2 diabetes drug, he suffered serious injuries, and seeks in excess of $75,000 in damages.
Plaintiff Claims Onglyza Lead to Heart Failure
According to his complaint, the plaintiff took Onglyza (saxagliptin) from September 2015 to April 2017. He followed his doctor’s instructions and took the drug as directed. While using it, however, he says that he had a heart attack and developed congestive heart failure, which he claims was caused by Onglyza. He was hospitalized for these conditions in November 2015 and January 2016.
As a result of these injuries, the plaintiff says that he has suffered pain, mental anguish, and disfigurement, and has lost earning capacity. He further expects to incur future medical expenses. He alleges that had the defendants been forthcoming about the risks associated with Onglyza, his doctors wouldn’t have prescribed it to him, or would have warned him of the risks.
He adds that he remained unaware of the connection between his condition and Onglyza until recently, because the defendants “actively concealed” the drug’s risks.
Defendants Wait Too Long to Test Onglyza for Cardiovascular Risks
Onglyza was approved by the FDA approval for sale in July 2009. It is one of a class of type 2 medications called “dipeptidyl peptidase-4 (DDP-4) inhibitors,” or “incretin mimetics,” which works by stimulating the pancreas to make insulin after a meal. This extra insulin helps keep blood sugar levels under control.
The drug also inhibits the action of incretin, a hormone which normally stimulates the production of insulin. The plaintiff states in his complaint that the drug manipulates the “natural biological incretin effect” by enabling the insulin-releasing process for longer period of time than what the body is used to. He says the company should have performed more testing of the drug to determine if this might increase the risk of cardiovascular problems, but didn’t.
In 2008, the U.S. Department of Health and Human Services, Food and Drug Administration, and Center for Drug Evaluation and Research, issued a Guidance for Industry in which it asked companies developing type 2 diabetes drugs to take steps to make sure their products were not associated with an unacceptable increase in cardiovascular risk. According to the plaintiff, however, the defendants “failed to perform adequate clinical trials to determine if their drugs created such an increased risk” during the development of the drug.
It wasn’t until Onglyza was already on the market that the manufacturers finally conducted a cardiovascular trial.
FDA Panel Recommends Increased Warnings
The trial was called the SAVOR trial. Researchers conducting the trial found that those patients taking Onglyza had a statistically significant increased risk of being hospitalized due to heart failure. The FDA requested the raw data from the trial, and performed its own analysis.
After confirming the results, the FDA scheduled a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee in April 2015. The panel recommended that the FDA require additional warnings on the drug to alert healthcare providers and patients of the risk of heart failure. The FDA did just that in 2016, but this was too little, too late for the plaintiff.