Onglyza, also known as saxagliptin, is a medication used to treat type 2 diabetes. Onglyza has been linked to an increased risk of pancreatic cancer and increased risk of heart failure. Some patients have filed Onglyza lawsuits against drug manufacturer AstraZeneca for numerous injuries caused by Onglyza, including heart failure, pancreatic cancer, and allergic reactions. Lawsuits are being filed against AstraZeneca claiming that they failed to perform adequate studies of Onglyza and did not provide proper warnings to patients about its adverse effects.

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What Is Onglyza?

Onglyza is the brand name of medications known as dipeptidyl peptidase-4 inhibitors (DPP-4), which are part of a larger category of incretin mimetics. This drug is supposed to control high blood pressure and prevent some of its worst side effects such as kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. 

How Does Onglyza Work?

Onglyza works by increasing levels of incretins, which help to control blood sugar by increasing insulin release. They also decrease the amount of sugar that the liver makes.

Onglyza is classified as a DPP-4 Inhibitor, meaning that it inhibits the enzyme DPP-4 which is responsible for degrading incretins as soon as they’re created. Slowing down DPP-4’s degradation of incretins allows for an increase in insulin in the body. 

What Is Onglyza Used To Treat?

Onglyza was approved by the FDA in July 2009 for the treatment of type 2 diabetes and is prescribed in combination with a diet and exercise plan to lower the blood sugar levels in non-insulin-dependent diabetics. 

What Are DPP-4 Inhibitors?

Drugs classified as DPP-4 inhibitors act through incretin hormones, which are gut hormones responsible for glucose equilibrium after a patient eats. These drugs prevent high blood sugar, high blood pressure, and anti-inflammatory effects, as well as help protect the patient’s heart, kidneys, and blood vessels by exerting anti-inflammatory and antioxidants. This prevents future infections. 

How Do DPP-4 Inhibitors Work?

DPP-4 inhibitors block the action of DPP-4, an enzyme that destroys incretin hormones. Incretins help the body produce more insulin when the body needs it or reduce the amount of glucose being produced in the liver when it is not needed. Incretins are released throughout the day and are increased at meal times to help the body maintain a normal glucose level. 

What Medications Are in the DPP-4 Inhibitor Family?

There are multiple DPP-4 inhibitors being produced. Because of their adverse effects, it’s important to be mindful of what medications you’re using. A list of DPP-4 inhibitors are listed below by their brand name: 

  • Januvia
  • Janumet
  • Galvus 
  • Eucreas
  • Onglyza
  • Vipidia
  • Vipdomet
  • Trajenta
  • Jentadueto 
  • Komboloyze

What Is Diabetes?

Diabetes is an umbrella term used to refer to a group of health conditions that impact the body’s ability to properly utilize glucose. Diabetes can be temporary in some circumstances, such as gestational diabetes which is associated with pregnancy. Chronic diabetes comes in two types: type 1 diabetes and type 2 diabetes. Type 1 diabetes is often called juvenile diabetes because it often begins in youth and it occurs when the pancreas just doesn’t make enough insulin. Type 2 diabetes, on the other hand, generally begins later in life and occurs when the pancreas isn’t producing enough insulin and there is too much sugar in the blood.

What Is Type 2 Diabetes?

Type 2 diabetes is a condition that occurs when there is a problem in the way the body regulates and uses glucose as fuel. This is a long-term condition that results in too much glucose circulating in the blood, leading to high blood sugar levels that can cause more medical disorders such as nerve damage, kidney disease, and skin conditions. 

There is no cure for type 2 diabetes, but there are medications, treatment plans, and lifestyle changes that are recommended by doctors to ease the symptoms associated with the condition.

What Are the Symptoms of Type 2 Diabetes?

The symptoms of type 2 diabetes can include:

  • Frequently needing to urinate
  • Increased feelings of hunger
  • Increased feelings of thirst
  • Fatigue
  • Blurry vision
  • Unintentional weight loss
  • Frequent infections
  • Sores that heal slowly
  • Numbness in the hands or feet
  • Tingling in the hands or feet
  • Darkened skin in the armpits and neck

What Causes Type 2 Diabetes?

The cause of type 2 diabetes isn’t known, but the disease occurs when liver, fat, and muscle cells start becoming resistant to insulin, meaning that those cells don’t take in enough sugar, and the pancreas doesn’t produce enough insulin, resulting in too much sugar in the bloodstream.

What Are the Risk Factors for Type 2 Diabetes?

While anyone can develop type 2 diabetes, there are certain people who are more at risk of the disease. The factors that can increase your risk include:

  • Family history
  • Being inactive
  • Being overweight
  • Body fat concentrating around the abdomen
  • Older age
  • Low blood lipid levels
  • Ethnicity
  • Having polycystic ovary syndrome
  • Having prediabetes
  • Being pregnant

What Complications Can Type 2 Diabetes Cause?

While treatment and controlling blood sugar levels can help to reduce the risk of complications, the following health problems could still occur as a result of diabetes:

  • Heart disease
  • Blood vessel disease
  • Nerve damage
  • Kidney damage
  • Eye damage
  • Skin problems
  • Slow healing
  • Dementia
  • Sleep apnea
  • Hearing impairment

Can Type 2 Diabetes Be Prevented?

While it may be impossible to completely prevent diabetes, there are some things you can do to reduce the risk of developing the condition:

  • Staying active
  • Eating healthily
  • Losing weight
  • Avoiding longer periods of inactivity

What Are the Side Effects of Onglyza?

It should be noted that Onglyza should only be used for type 2 diabetes and is not approved for the treatment of type 1 diabetes. Onglyza side effects are typically mild to moderate and may go away with time.

Some of Onglyza’s common side effects include: 

  • Joint pain
  • Low blood sugar
  • High blood sugar
  • Nasal stuffiness
  • Runny nose
  • Sore throat
  • Headache
  • Nausea 
  • Diarrhea
  • Painful urination
  • Bloating

Onglyza can also cause some allergic reactions such as: 

  • Rash 
  • Hives
  • Itching
  • Swelling of face, tongue, or lips
  • Difficult breathing

What Is the Link Between Onglyza With Pancreatitis and Pancreatic Cancer?

A study was performed on similar incretin-type medications and the results published in March 2013 showed that incretin or incretin-mimicking drugs may increase pancreatic masses and induce precancerous changes. This increased risk was confirmed by the FDA when they released a warning in 2014 of the increased risk of pancreatic cancer and pancreatitis for Onglyza users. 

What Is Pancreatitis?

Pancreatitis is the inflammation of the pancreas, which is a part of one’s immune system. Inflammation can cause swelling, pain, and changes in how the organ operates. 

What Are the Symptoms of Pancreatitis?

Some pancreatitis symptoms to keep an eye out for include: 

  • Pain in upper stomach
  • Nausea and vomiting
  • Abdominal tenderness
  • Fever
  • Rapid heart rate

What Is Pancreatic Cancer?

Pancreatic cancer is a type of cancer that begins as an excess growth of cells in the pancreas. This type of cancer is rarely caught in its early stages since symptoms aren’t portrayed in the body until the cancer spreads to other organs. 

What Are the Symptoms of Pancreatic Cancer?

When symptoms do occur, some that may appear include:

  • Belly pain that spreads to the sides of the back
  • Loss of appetite
  • Weight loss
  • Jaundice
  • Light-colored or floating stools
  • Dark colored urine
  • Itching
  • Development or worsening symptoms of diabetes
  • Pain in swelling in arms or legs, leading to blood clots
  • Tiredness and weakness

What Is the Link Between Onglyza and Heart Failure?

It was shown in the 2013 New England Journal of Medicine that there was a 27% increase in heart failure and heart-related hospitalizations in Onglyza users. This prompted the FDA to do their own investigation where they concluded that there may also be an increased risk of death. 

What Is Heart Failure?

Heart failure is a term used to say that the heart isn’t pumping as well as it should. The body is dependent on the heart’s pumping to deliver oxygen and nutrient-rich blood to the body cells. When the heart cannot supply the cells with nutrients and oxygen, they can begin to die. 

What Are the Symptoms of Heart Failure?

Some symptoms of heart failure include:

  • Continuing cough
  • Wheezing
  • Difficulty breathing
  • Swelling of hands, feet, or ankles
  • Irregular heartbeat
  • Fatigue

What Are the FDA’s Warnings About Onglyza?

The first warning the FDA gave on Onglyza was in February 2014 when it requested further trials to investigate the association between Onglyza and other DPP-4 inhibitors and heart failure. This safety announcement was brought to the attention of the public in hopes of preventing further prescribing and usage unless absolutely necessary. There were no generic forms of Onglyza that the FDA could recommend in place of Onglyza and other DPP-4 inhibitor medications. 

An updated safety announcement was given in April 2016 to confirm that there was a link to an increased risk of heart failure from drugs like Onglyza, which contain DPP-4 inhibitors saxagliptin and alogliptin. They urge healthcare professionals to consider discontinuing the medicine in patients who are at risk of developing heart failure and prompt patients to stop taking the medication if they have any similar heart failure symptoms. 

Is Onglyza Still on the Market?

In March 2023, AstraZeneca discontinued the manufacturing of Onglyza and there is no generic option available on the market. According to t Astrazeneca, their choice to discontinue production of Onglyza was a business decision and not due to safety or efficacy-related concerns.

What Are Alternatives to Onglyza?

There are a multitude of drugs available to help treat type 2 diabetes. It’s important to talk to your doctor about what medications will work best for you. Some of the other drugs that are used to treat type 2 diabetes are: 

  • Glumetza
  • Junavia
  • Tradjenta
  • Invokana
  • Farxiga
  • Jardiance
  • Victoza
  • Amaryl
  • Levemir

Has Onglyza Been Recalled?

AstraZeneca, the manufacturer of Onglyza, hasn’t recalled the medication. Instead, the company has permanently discontinued the medication.

Why Are There Onglyza Lawsuits?

AstraZeneca has been hit with a number of lawsuits due to Onglyza’s reported link to pancreatitis, pancreatic cancer, and heart failure. These connections were found through many studies and trials, which suggested that AstraZeneca had failed to perform thorough enough research and tests before marketing the drug to the public. This led to the manufacturers being accused of negligence by plaintiffs. 

Why Are Plaintiffs Filing Onglyza Lawsuits?

Plaintiffs who developed pancreatitis, pancreatic cancer, heart failure, and even extreme cases of hypoglycemia are filing lawsuits against AstraZeneca. They are hoping to receive compensation for medical bills since they claim the manufacturers of Onglyza failed to warn them of these serious side effects.

Are There Onglyza Lawsuit Settlements?

As of October 2023, none of the Onglyza lawsuits have been settled or resolved, and the prospects are very slim due to previous lawsuits involving Onglyza being dismissed by judges.

Are There Active Onglyza Lawsuits?

In federal court, more than 200 Onglyza lawsuits are pending. There are even more pending in state courts, but none have been resolved and many law offices aren’t taking new Onglyza lawsuits at this time. This concerns previous lawsuits being dismissed by judges and low prospects of courts ruling in favor of the plaintiffs.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.