What is Onglyza?
Onglyza (saxagliptin) is a type 2 diabetes drug that was approved by the FDA in 2009. It helps to control blood sugar levels. It is a newer type of medication known as dipeptidyl peptidase-4 inhibitors (DPP-4) which are a part of the larger category of “incretin mimetics”. DPP-4 inhibitors like Onglyza work by increasing levels of natural substances called incretins, which control blood sugar by increasing insulin release, especially after a meal. They also decrease the amount of sugar the liver makes, resulting in lower blood sugar levels.
Onglyza was first approved in 2009 for the treatment of Type 2 diabetes. It is to be used “in combination” with diet and exercise to lower blood sugar in non-insulin dependent diabetics. It is manufactured and marketed by the London-based, AstraZeneca, a pharmaceutical giant with an estimated annual income of $26 billion. The medication brought in approximately $820 million in 2014 alone.
Onglyza has been shown to increase the risk of heart failure and heart-failure hospitalizations. It may also be thought to increase the risk of pancreatitis and pancreatic cancer and increase the risk of death from all causes. AstraZeneca has faced numerous Onglyza lawsuits due to injuries that may have been caused by the medication.
About DPP-4 Inhibitors
Type 2 diabetes affects millions of American adults and is responsible for 95 percent of all diabetes cases. It is caused by the body’s inability to produce enough insulin or a decreased sensitivity of the body cells to existing insulin which is needed to transport glucose from the blood stream into the cells where it can be used as energy. If glucose remains in the bloodstream, it becomes “toxic” to many body tissues, particularly the kidneys, eyes, and vascular tissue.
DPP-4 inhibitors like Onglyza work to lower blood sugar by blocking glucose release from the liver, by increasing the secretion of insulin from the pancreas and by decreasing “gastric emptying time” in the stomach which results in a lower absorption of sugar.
These actions are accomplished by increasing the activity of a naturally-occurring hormone, incretin. Certain other antidiabetic medications work similarly by acting as synthetic incretins or mimicking the activity of incretin as incretin “mimetics”. Incretin type drugs that act similarly to the DPP-4 inhibitors like Onglyza, have been suspected of causing a number of serious side effects and have been the subject of numerous lawsuits.
Onglyza FDA Warnings
In April of 2015, an FDA safety panel recommended that additional warnings be added to prescribing information for the popular antidiabetic medication, Onglyza, due to concerns about an increased risk of heart failure.
A medical study involving over 16,000 patients showed that Onglyza increased the occurrence of heart failure-related hospitalization by as much as 27 percent and an FDA safety panel concluded that an increased risk of death from all causes could not be ruled out.
Onglyza has been suspect previously due to the action of similar drugs which may increase the risk of pancreatitis and pancreatic cancer but no direct link to Onglyza has been found yet. One safety panel member voted to withdraw the drug from the market, but the overall recommendation was for increased labelling which may ultimately be added to Onglyza and similar medications.
Onglyza Heart Failure
In 2008, after many newer antidiabetic drugs had begun showing signs of high rates of serious adverse events, the Food and Drug Administration began requiring manufacturers perform safety studies to show that any additional drugs intended for market did not pose a higher-than-normal heart risk. The FDA’s requirements indicated that drugs could show no more than a 30 percent increase in heart events.
Onglyza was one of the first of the newer generation Type II antidiabetic medications to comply with the request for additional testing. The results of the safety study designed to answer the cardiac question were published in a 2013 New England Journal of Medicine article and showed a 27 percent increase in heart failure-related hospitalizations.
Though the 2013 SAVOR study results of 27 percent increase in heart complications were slightly below the 30 percent threshold, the FDA’s review of the trial prompted an additional investigation which concluded that there may also be an increased risk of overall death.
One safety review panel member indicated a belief that the drug should be withdrawn but the panel of the FDA voted in April of 2015 to recommend additional warning be added to prescribing information for Onglyza and one other DPP-4 inhibitor.
Thus far, the FDA has not taken official action and may be waiting on study results from other DPP-4 inhibitors before making a final judgement.
Symptoms of heart failure can include:
- Continuing cough
- Difficulty breathing
- Swelling of hands, feet or ankles
- Irregular heart rate
- Fatigue or activity intolerance
Onglyza Pancreatitis and Cancer
Some incretin-type medications have shown the possibility for a higher-than-normal risk of pancreatitis, which may increase the risk of pancreatic cancer. March 2013 study results published in Diabetes magazine showed that certain incretin or incretin mimicking drugs may increase pancreatic mass and induce precancerous changes.
Though the study was not conducted on Onglyza, the activity of DPP-4 inhibitor’s similarity has raised concerns about the medication’s potential for increased cancer risk.
Pancreatitis may cause symptoms such as:
- Pain in upper stomach, possibly radiating to back
- Nausea and vomiting
- Abdominal tenderness
- Rapid heart rate
Onglyza Side Effects
All medications cause side effects. Aside from the more serious concerns about heart and pancreatic effects, most of the side effects of Onglyza are mild-to-moderate and may go away with time.
Onglyza’s other side effects include:
- Joint pain
- Low blood sugar, especially if using Onglyza with other anti-diabetic medications
- High blood sugar
- Nasal stuffiness or runny nose
- Sore throat
- Painful urination
Onglyza may also cause allergic reactions such as:
- Swelling of face, tongue or lips
- Difficulty breathing
Any severe or bothersome symptoms should be reported to a medical professional right away. Any heart or pancreatic symptoms should be treated as a medical emergency.
Onglyza’s manufacturer, AstraZeneca has faced a number of lawsuits filed by people or loved ones of those who may have been injured by the medication. Though cases for pancreatic injury, pancreatitis and pancreatic cancer were dismissed, federal Onglyza heart failure lawsuits have been consolidated into multidistrict litigation (MDL) in the Eastern District of Kentucky. The MDL, formed in 2018, also includes lawsuits for Kombiglyze XR, manufactured by Bristol-Myers Squibb which also contains the active ingredient sitagliptin.
Plaintiffs claim the medication caused heart failure, congestive heart failure, heart attack or other cardiovascular injury. They are focused on a lack of adequate studies and warnings at the time of the drug introduction, despite an FDA order in 2008 which showed a high potential for risk for the entire category.
A number of California state Onglyza lawsuits may also have been consolidated in California state courts. Federal bellwether cases were set to start in late 2020 but may have been delayed due to pandemic conditions. People who believe they or a loved one was harmed by Onglyza should seek legal assistance.
- Onglyza Prescribing Information, RxList (12/2020)
- FDA Advisory Committee reviews SAVOR outcomes study results for ONGLYZA® (saxagliptin) and KOMBIGLYZE® XR (saxagliptin and metformin HCI extended-release), AstraZeneca (04/2015)
- FDA Panel Backs New Safety Warnings on Two Diabetes Drugs, Medscape (04/2015)
- 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 (03/2013)
- Saxagliptin and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus, New England Journal of Medicine (03/2013)