Onglyza Class Action Lawsuit

Claims filed in federal MDL court over Onglyza heart failure.

The first Onglyza lawsuit filed in 2016 was brought by the family of an Illinois woman who suffered multiple hospitalizations and eventual death from heart failure after taking Onglyza for approximately 3 years.

onglyza lawsuit

Onglyza MDL Lawsuit

In the years since, nearly 90 patients with similar heart injuries have filed claims around the country. However, most people still don’t know of the risks or pending litigation.

Now, the Judicial Panel on Multidistrict Litigation has ordered that all pending claims be consolidated into a federal multidistrict litigation court, similar to an Onglyza class action lawsuit. This is likely to bring added attention to the heart risks and greater access to courts for those affected.

Plaintiff Carolyn Williams filed the petition for MDL, and the JPML held a hearing to determine centralization on January 25, 2018. The panel ordered the class action-like MDL will be presided over by Chief U.S. District Judge Karen Caldwell in the Eastern District of Kentucky.

AstraZeneca and Bristol-Myers Squibb, the makers of Onglyza, opposed creating a class action MDL or joining the numerous cases together, saying there weren’t enough cases and that they don’t expect many more to be filed. In reality, drug makers often argue against MDL and Class Action certification in order to avoid the added publicity that attracts additional plaintiffs.

From now on, the Onglyza Class Action Lawsuit will be formally known as MDL Docket 2809, under the heading In Re: Onglyza and Kombiglyze Products Liability Litigation. DrugNews will continue to monitor the litigation and provide updates.

Onglyza Heart Failure

In February 2018, the Judicial Panel on Multidistrict Litigation issued a Transfer Order to centralize all federal heart failure lawsuits for the drugs Onglyza and Kombiglyze to Multidistrict Litigation Court MDL 2809 in the Eastern District of Kentucky.

The panel noted at least 84 heart failure lawsuits have been filed in more than 30 separate districts around the country against AstraZeneca, the maker of Onglyza. These will likely increase due to the popularity of the drug.

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Patient Risks

On April 5, 2016, the Food and Drug Administration issued a warning to doctors and the public that the type 2 diabetes Onglyza (saxagliptin) and Nesina (alogliptin) may increase the chances of heart failure, especially in those with prior heart or kidney problems.

Label Warning Added for Heart Failure

The FDA cautioned patients taking either Onglyza or Nesina to monitor for the symptoms of heart failure, which may include:

  • Difficulty breathing        
  • Tiredness
  • Weakness
  • Shortness of breath
  • Fatigue
  • Swelling in legs or stomach
  • Weight gain.

Heart failure, or congestive heart failure, isn’t a sudden stop in heart function as it sounds, but rather a gradual weakening of the heart’s ability to pump enough blood to supply the body. Although the condition can be managed with medications and a change in lifestyle, there is no cure, and can shorten the life expectancy of those affected.

2016 FDA Warning

The 2016 warning came after a two-year formal investigation by the FDA, prompted by an October 2013 study of Onglyza heart risks published in the New England Journal of Medicine.

Following more than 16,000 patients, researchers at Harvard/Brigham and Womens Hospital found that those taking Onglyza were up to twice as likely to be hospitalized for heart failure.

In addition, the FDA Adverse Events Reporting System (FAERS) indicates the agency has received numerous reports of cardiovascular and other severe side effects in those taking Onglyza so far, including:

  • 303 reports of cardiac failure
  • 76 reports of heart attack
  • 60 reports of atrial fibrillation
  • 136 reports of pancreatitis
  • 84 reports of pancreatic cancer
  • 160 reports of death.

Experts estimate the actual number of complications could be 3-4 times as high as the number reported, meaning thousands of patients have suffered injury.

Drug Class, Dosage & Side Effects

Onglyza is the brand name for saxagliptin, an oral prescription medication prescribed to help patients with type 2 diabetes control their blood sugar levels.

Diabetes Drug
2.5 & 5 mg
Coated Tablet
July 31, 2009
FDA Approved

Onglyza is available as a coated tablet in 2.5 and 5 mg doses, and is taken once daily.

Onglyza was developed jointly by the drug companies Bristol-Myers Squibb and AstraZeneca, and is now sold by AstraZeneca. It was approved by the FDA on July 31, 2009.

Onglyza belongs to a class of diabetes drugs called DPP-4 inhibitors, which also includes Januvia and Nesina. These drugs work by increasing the production of incretin hormones that block the action of the pancreatic hormone glucagon. This raises insulin levels while reducing blood glucose levels.

Onglyza may be prescribed alone or in combination with other diabetes medications.  When combined with metformin, it is known as Kombiglyze. It is not intended to treat type-1 diabetes.

Listed Side Effects

In addition to the recently-added risks of heart failure, Onglyza is associated to a number of other side effects. The Medication Guide from AstraZeneca lists the following possible side effects:

  • Pancreatitis
  • Skin blisters or sores
  • Urinary tract infection
  • Joint pain
  • Swelling or fluid retention deficiency
  • Headache
  • Low blood sugar (hypoglycemia)
  • Upper respiratory tract infection.

FDA Adverse Reports

Death Cases
Cardiac Failure
Serious Cases
Total Cases

Allergic Reactions on Label

In addition, the label warns of possible allergic reactions from Onglyza, including:

  • Hives, itching, rash, or peeling skin
  • Difficulty swallowing
  • Swelling of the skin
  • Difficulty breathing
  • Swelling of the face, lips, or throat.

If you experience any of these side effects, it is important to speak with your doctor immediately.

Patient Prior Conditions

In addition, patients should tell their doctor if they’ve suffered any of the following before they begin taking Onglyza:

  • Pancreatitis
  • Kidney problems
  • Currently pregnant or breastfeeding
  • Heart problems.

For more information on the studies, warnings, side effects or litigation related to Onglyza, contact DrugNews today to speak with a lawyer.

Onglyza Lawyer

If you have questions about whether your injury might be related and whether you are eligible for a case, it is best to speak with a lawyer as soon as possible.

Lawyers are currently investigating cases on behalf of those patients who took Onglyza and suffered:

  • Heart failure
  • Cardiovascular problems
  • Pancreatic cancer
  • Death.

If you have questions about whether your injury might be related and whether you are eligible for a case, it is best to speak with a lawyer as soon as possible.

An Onglyza lawyer can review your specific circumstances and history of medication use to determine if your case might qualify. And, they can file and pursue your case for you, so in most cases you won’t have to travel. Most importantly, it costs nothing to speak with a lawyer or file a case unless you receive an award.

However, your rights might be limited by the Statutes of Limitation in your state, or the dates that you took the medication. Therefore, it’s important to get your claim started as early as you can.

DrugNews’ lawyers have handled hundreds of cases involving heart failure, death and pancreatitis from diabetes medications. Contact us today to speak directly with a lawyer at no cost.

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