Onglyza lawsuits are mass tort claims against Bristol-Myers Squibb and AstraZeneca for the side effects of their anti-diabetic drug, Onglyza. This drug has been linked to numerous medical conditions, including pancreatic cancer and heart failure. The lawsuits claim that the pharmaceutical companies failed to warn doctors and patients about the risks of taking Onglyza, and seek compensation for:
- Medical expenses,
- Lost wages,
- Reduced earning capacity, and
- Pain and suffering.
- 1. What is Onglyza?
- 2. Side effects of Onglyza
- 3. Lawsuits over side effects caused by Onglyza
- 4. Compensation for victims of Onglyza
- 5. What you can do if you think you have been hurt by Onglyza
- 6. What to do if a loved one has suffered from Onglyza
1. What is Onglyza?
Onglyza is the brand name of a prescription drug, saxagliptin, which treats type 2 diabetes in adults. It comes in the form of a pill.
Onglyza works by mimicking the hormone incretin, which triggers the release of insulin after eating. People who suffer from diabetes do not produce enough insulin, largely because they lack incretin, and this lowers their blood sugar. Onglyza helps to raise a diabetic's blood sugar levels by standing in for incretin and producing insulin.
Onglyza was created by the pharmaceutical giants Bristol-Myers Squibb and AstraZeneca. It was first approved by the U.S. Food and Drug Administration (FDA) in 2009 to treat adults with diabetes.1
2. Side effects of Onglyza
Onglyza has been linked to numerous side effects. Some of the most common include:
- Joint pain,
- Abnormal levels of blood sugar,
- Allergic reaction, and
- Symptoms of a common cold, like a runny nose, headaches, cough, and sore throat.
However, there are also some severe side effects that have been linked to Onglyza, including:
- An increased risk for heart failure, and
- Pancreatic cancer.
2.1 Onglyza and heart failure
Onglyza has been found to significantly increase the risk of heart failure.
Diabetes drugs that work like Onglyza have been known to threaten the heart. That is why, in 2008, the FDA issued guidance to pharmaceutical companies, asking them to monitor how their diabetes drugs impacted a patient's risk of developing heart problems.2 When Onglyza hit the market in 2009, the FDA required AstraZeneca to conduct a post-marketing study on the drug's heart risks.
That post-marketing study was called the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus study, or SAVOR, and was published in the New England Journal of Medicine in 2013.3
The SAVOR study included 16,492 patients who either took Onglyza or a placebo. The study followed them for about two years to see if they developed a heart condition.
Out of the patients in the study, 2,093 suffered a major cardiovascular event like:
- Cardiovascular death,
- Myocardial infarction,
- Heart failure,
- Coronary revascularization, or
- Unstable angina.
The differences between the placebo group and the patients on Onglyza were relatively small for many of these heart issues. However, when it came to heart failure, the study found that patients who were taking Onglyza were 27 percent more likely to be hospitalized than the patients taking a placebo.
The results of the SAVOR study pushed the FDA to update the warning label on Onglyza so it included a warning about the increased risk for heart failure. That updated warning label, however, did not appear in the U.S. until 2016.4
2.2 Onglyza and pancreatic cancer
Antidiabetic drugs that use incretin hormones, including Onglyza, have long been thought to influence pancreatic cells, as well.5 It took until 2013 for the FDA to investigate the connection between incretin hormone pills, like Onglyza, and pancreatitis and pancreatic cancer.6
The increased risk for pancreatitis and pancreatic cancer was not added to the warning label for Onglyza until 2016.7
3. Lawsuits over side effects caused by Onglyza
Numerous lawsuits have been filed against Bristol-Myers Squibb and AstraZeneca for the side effects caused by Onglyza. These lawsuits claim that the pharmaceutical companies knew about the dangers posed by their antidiabetic drug, but failed to warn consumers in time for them to make informed health decisions.
These lawsuits claim that, by failing to warn people about the risks for heart failure and pancreatic cancer that have been associated with Onglyza, Bristol-Myers Squibb and AstraZeneca breached their legal duty to disclose those dangers. The lawsuits claim this breach caused innocent people to get hurt, though no fault of their own. They seek compensatory damages to cover the losses that these victims have suffered.
3.1 Lawsuits for pancreatitis and pancreatic cancer
So far, Onglyza is one of the few incretin-based antidiabetic pills that have not been made a part of a multidistrict litigation (MDL) over pancreatitis and pancreatic cancer.
MDLs consolidate mass tort claims for pretrial procedures, like the gathering of evidence and preliminary motions, into a single federal court.
The MDL for pancreatic cancer from incretin-based diabetic pills is taking place in the Southern District of California.8 While it does not include Onglyza, it does include many other incretin-based antidiabetic pills, including:
- Byetta, and
As of April 15, 2019, this MDL consisted of 942 claims.10
Instead, victims of pancreatitis or pancreatic cancer who have been hurt by Onglyza have pursued their legal rights individually.
3.2 Lawsuits for heart failure
Most of the claims against Bristol-Myers Squibb and AstraZeneca for Onglyza's side effects have been over the increased risk for heart failure that the drug causes.
Since studies began connecting heart failure to Onglyza, so many lawsuits have been filed against Bristol-Myers Squibb and AstraZeneca that it created another MDL to streamline the process.11 This MDL has been assigned to the Eastern District of Kentucky.12 As of April 15, 2019, there were already 272 claims in the MDL.13
However, numerous lawsuits in California were filed in state court, rather than in federal court. These claims were not included in the MDL, and continue to be heard in the California Superior Court for the County of San Francisco.14
4. Compensation for victims of Onglyza
Victims who have developed pancreatitis, pancreatic cancer, or have suffered from heart failure can recover compensation for their losses. This compensation aims to cover a victim's:
- Medical bills, both from the past and those likely to arise in the future,
- Wages lost during the recovery process,
- A reduced ability to earn a living in the future,
- Physical pain,
- Mental suffering and anguish, and
- The loss of companionship and consortium felt by the victim's family.
5. What you can do if you think you have been hurt by Onglyza
If you suspect that you have been hurt by the drug Onglyza, the first thing to do is see a doctor. This is particularly important if you have developed the symptoms of heart failure, which can include:
- Shortness of breath,
- Chest pain,
- Persistent cough,
- Abdominal swelling,
- Swelling of the extremities, hands, feet, or ankles, and
- Irregular heartbeat.
It is also important to see a doctor if you have begun to suffer from signs of pancreatitis, which can include:
- Persistent vomiting,
- Back pain, and
- Severe stomach or abdominal pain.
If you see a doctor and learn that you have pancreas problems or need treatment for heart failure, you should consider talking to a defective drug lawyer like those at the Shouse Law Office. Talking to an attorney can help you understand your rights and legal options.
Doing so quickly, though, is important. Most states have statutes of limitations that require a lawsuit to be filed within two years of the injuries. Calling our law office at 855-LAWFIRM well before that time period has elapsed can help us put together a strong case for compensation.
6. What to do if a loved one has suffered from Onglyza
If it was a loved one who has suffered from heart failure or pancreas problems, and they have passed away or are too incapacitated to invoke their own rights, you can talk to a lawyer about what to do next. Filing a wrongful death case can be an option, and can hold a giant pharmaceutical company accountable for their poor actions and decisions.
FDA, Center for Drug Evaluation and Research, “Guidance for Industry Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes,” (December 2008).
Scirica B, et al., “Saxagliptin and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus,” 369(14):1317-26 (October 3, 2013).
FDA Drug Safety Communication, “FDA adds warnings about heart failure risk to labels of type 2 diabetes medicines containing saxagliptin and alogliptin,” (April 5, 2016); FDA Warning Label for Onglyza – 2016.
See Butler A, Campbell-Thompson M, Gurlo T, Dawson D, Atkinson M, Butler P, “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 62(7):2595-2604 (July 2013); Matveyenko AV, Dry S, Cox HI, Moshtaghian A, Gurlo T, Galasso R, Butler AE, Butler PC, “Beneficial endocrine but adverse exocrine effects of sitagliptin in the human islet amyloid polypeptide transgenic rat model of type 2 diabetes: interactions with metformin.” Diabetes. 58(7):1604-15 (July 2009).
FDA Drug Safety Communication, “FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes,” (March 14, 2013).
MDL 2452, In re: Incretin Mimetics Products Liability Litigation.
See In re: Incretin Mimetics Products Liability Litigation, MDL No. 2452 (transfer order) (August 26, 2013).
MDL Statistics Report – Distribution of Pending MDL Dockets by District (April 15, 2019).
In re: Onglyza and Kombiglyze XR Products Liability Litigation, MDL No. 2809 (transfer order) (February 2, 2018).
See note 10.