What is Onglyza?
Onglyza (generic: saxagliptin) is an incretin mimetic oral dipeptidyl peptidase-4 (DPP-4) inhibitor that helps control blood sugar levels in patients with type 2 diabetes. The drug works by regulating the levels of insulin the body produces after eating. Onglyza is made by Bristol-Myers Squibb, distributed by Bristol-Myers Squibb and AstraZeneca Pharmaceuticals, and was approved by the U.S. Food & Drug Administration (FDA) in July 2009.
What’s the Problem?
Since Onglyza hit the U.S. market in 2009, it has been linked to numerous reports of pancreatitis, pancreatic cancer, thyroid cancer, heart failure and other serious side effects. Former users of the drug have filed lawsuits alleging that the manufacturer failed to adequately warn of these risks.
Onglyza Side Effects
- Pancreatic Cancer
- Thyroid Cancer
- Heart Failure
- Acute Pancreatitis
- Hemorrhagic Pancreatitis
- Necrotizing Pancreatitis
- Kidney Damage
- Renal Failure
- And more
An FDA advisory panel voted in April 2016 to require new warnings on the labeling of Onglyza and other DPP-4 inhibitors regarding a potential increased risk of heart failure, particularly in patients with a history of heart or kidney disease. The decision came after the panel reviewed data from the SAVOR trial, which involved 16,492 patients, 1,222 of whom reported a major cardiovascular event.
For the study, AstraZeneca was required to demonstrate that Onglyza would not increase the risk of heart failure or other cardiovascular side effects by more than 30%. The results indicated that Onglyza users had a 27% increased risk of hospitalization for heart failure compared to patients in the control group. Despite AstraZeneca meeting the required threshold, the FDA panel determined that more data was needed to determine the actual risk of death from all causes associated with Onglyza. Indeed, 14 of the 15 panelists voted in favor of placing a warning on the labeling of Onglyza, while one panel member voted to withdraw the drug completely from the U.S. market.
Symptoms of Heart Failure
- Difficulty breathing
- Swelling of hands, feet or ankles
- Irregular heart rate
- Persistent cough or wheezing
Pancreatitis and Pancreatic Cancer
A study published in JAMA Internal Medicine in April 2013 found a doubled risk of pancreatitis associated with use of incretin mimetic diabetes drugs like Onglyza.
“Since most risk factors for acute pancreatitis are also linked to an increased risk of pancreatic cancer, these findings of changes in the human pancreas are very concerning,” said Dr. Sonal Singh of Johns Hopkins University School of Medicine and Public Health, lead author of the study.
Another study published in the journal Diabetes in July 2013 found that incretin mimetics cause abnormal pancreatic growth in humans that may be associated with neuroendocrine tumors, which could increase the risk of pancreatic cancer. The researchers found an approximately 40% increase in cell mass in the pancreases of deceased organ donors who had used the medications. The increase in pancreas size was linked to increased cellular proliferation, including an abnormal form of cell proliferation, a known risk factor for pancreatic cancer.
Pancreatic Cancer Symptoms
- Unexplained fatigue or weight-loss
- Sudden worsening of type 2 diabetes
- Abdominal pain, tenderness, swelling
- Nausea or vomiting
- Dark urine and/or light-colored stools
- Jaundice (yellow skin or whites of the eyes)
July 2009 – Approved by the FDA
July 31, 2009 – Onglyza approved by the U.S. Food & Drug Administration (FDA).
March 2013 – Cancer risk investigation launched
March 14, 2013 – FDA announces investigation into pancreatic cancer risk with Onglyza and other incretin mimetic diabetes drugs.
April 2013 – JAMA study findings
April 8, 2013 – JAMA Internal Medicine study finds doubled risk of pancreatitis with incretin mimetics.
July 2013 – Diabetes journal study published
July 2013 – Study published in the journal Diabetes finds that incretin mimetics cause abnormal pancreatic growth that may be associated with neuroendocrine tumors, a known risk factor for pancreatic cancer.
August 2015 – FDA Drug Safety Communication issued
August 28, 2015 – FDA Drug Safety Communication issued over reports of severe joint pain in patients treated with DPP-4 inhibitor diabetes drugs.
April 2016 – FDA label requirement
April 5, 2016 – FDA requires heart failure warning on labels of Onglyza and other DPP-inhibitors.
- “FDA Approves New Drug Treatment for Type 2 Diabetes”. U.S. Food & Drug Administration (FDA). July 31, 2009.
- “Incretin Mimetic Drugs for Type 2 Diabetes: Early Communication – Reports of Possible Increased Risk of Pancreatitis and Pre-cancerous Findings of the Pancreas”. U.S. Food & Drug Administration (FDA). March 14, 2013.
- “Glucagonlike Peptide 1–Based Therapies and Risk of Hospitalization for Acute Pancreatitis in Type 2 Diabetes Mellitus: A Population-Based Matched Case-Control Study”. JAMA Internal Medicine. April 8, 2013.
- “Marked Expansion of Exocrine and Endocrine Pancreas With Incretin Therapy in Humans With Increased Exocrine Pancreas Dysplasia and the Potential for Glucagon-Producing Neuroendocrine Tumors”. Diabetes. July 2013.
- “Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes and moderate or severe renal impairment: observations from the SAVOR-TIMI 53 Trial”. Diabetes Care. April 2015.
- “FDA Drug Safety Communication: FDA warns that DPP-4 inhibitors for type 2 diabetes may cause severe joint pain”. U.S. Food & Drug Administration (FDA). August 28, 2015.
- “Diabetes Medications Containing Saxagliptin and Alogliptin: Drug Safety Communication – Risk of Heart Failure”. U.S. Food & Drug Administration (FDA). April 5, 2016.