Onglyza (saxagliptin) – co-developed by Bristol Meyers Squibb and AstraZeneca – joins a list of some newer diabetes drugs that have alarmed patients and their doctors. Several lawsuits have been filed regarding complications allegedly caused by Actos, Januvia, and Janumet. Patients taking Onglyza may also have cause for concern. An FDA advisory committee recently raised red flags regarding two dipeptidyl peptidase-4 inhibitors: Onglyza, (saxagliptin, Bristol-Myers Squibb/AstraZeneca) and Nesina (algoliptin, Takeda Pharmaceuticals).
Bristol and Astra also produce a similar medication called Kombiglyze XR which combines saxagliptin with metformin (another diabetes drug). Both belong to a class known as DPP-4 inhibitors.
Onglyza Warning Label
A panel majority voted to update the labels of both Onglyza and Nesina to reflect the latest information concerning safety concerns, particularly the results of cardiovascular outcome studies. An Endocrinologic and Metabolic Drugs Advisory Committee panel voted 14-1 to update the label for Onglyza to warn patients of the potential for an increased risk of heart failure.
One panel member voted to withdraw Onglyza from the U.S. market. The panel noted that more information would be needed regarding a possible increased risk of death from all causes in association with the drug.
Onglyza Cardiovascular Event Risks
In 2008, the FDA requested that makers of any new type 2 diabetes medications show they were not linked to a significant increase in cardiovascular events. Onglyza was one of the first drugs with a completed safety study to comply.
FDA asked drug makers to show their product does not increase the risk of heart failure or any other cardiovascular condition by 30 percent or more. The finished study involved 16,492 participants with type 2 diabetes and cardiovascular disease or risks of cardiovascular disease. A total of 1,222 patients reported major adverse cardiovascular events, a hazard ratio of 1.00, safely below the 30 percent threshold.
FDA panelists noted, however, that those taking this class of diabetes drug showed a 27 percent increase in the rate of hospitalization for heart failure. They further established a potential for an increased risk of death. (Just a side effect in the parlance of our times.)
“An effect on all-cause mortality really cannot be ruled out,” said Robert J Smith, MD, committee chair and professor of medicine at Alpert Medical School of Brown University.
Onglyza Side Effects
• Pancreatic Cancer
• Thyroid Cancer
• Acute Pancreatitis
• Hemorrhagic Pancreatitis
• Necrotizing Pancreatitis
• Kidney Complications
• Renal Failure