Recently, the FDA requested new studies take place to investigate the safety of diabetes drugs. One such study known as “SAVOR“, which was published by the New England Journal of Medicine, found that diabetes drugs containing DPP-4 inhibiting saxagliptin – specifically Onglyza by AstraZeneca – increased the patient’s risk for being hospitalized with heart failure by 27%.
Following the study, the FDA launched an investigation to further explore the link between Onglyza and heart failure. In their preliminary review, they found that not only was there an increased risk for hospitalization due to heart failure, but there was an increase in the rate of death from all causes.
History of Onglyza and Pancreatitis, Pancreas Cancer and Thyroid Cancer
Onglyza, or saxagliptin, belongs to a class of drugs known as “incretin-based therapies” that inhibit the production of dipeptidyl peptidase 4 (DPP-4). DPP-4 inhibitors help the pancreas secrete more insulin and stop the liver from making excess sugar. According to British Medical Journal editor Deborah Cohen, when DPP-4 drugs first appeared on the market, they were “touted… as the biggest breakthrough since the discovery of insulin nearly a hundred years before.”
However, doctors soon became concerned by reports of possible increased risk of pancreatitis and pancreatic and thyroid cancer associated with these drugs. Many patients who developed pancreatitis or pancreatic cancer began filing lawsuits against the drugs’ manufacturers, claiming that the drug makers knew about, but did not warn the public of, the link between DPP-4 inhibitors and pancreas cancer.
While the link between DPP-4 inhibitors and pancreas cancer is now fairly well known, the news of Onglyza potentially increasing risk of death from all causes is only now coming to light.
Onglyza Investigation: The Link Between Onglyza, Serious Injuries and Wrongful Death
Onglyza has become quite popular due in part to its efficacy at controlling blood sugar, but also because it does not encourage weight gain like other diabetes medications. In 2012, AstraZeneca made $709 million from sales of Onglyza, and analysts say that by 2018, annual sales of the drug could reach $2.47 billion. But at what cost?
On the heels of the FDA’s findings, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended with a 14-1 vote that Onglyza should be re-labeled to warn patients of a higher than expected risk of hospitalization for heart failure and all causes of death. The FDA must now decide whether to follow the panel’s recommendations.