Onglyza Lawsuit | Diabetes Drug Linked to Heart Conditions

Written By:
Jessie Paluch
Jessie Paluch

Attorney Jessie Paluch, founder of TruLaw, has over 25 years of experience as a personal injury and mass tort attorney, and previously worked as an international tax attorney at Deloitte. Jessie collaborates with attorneys nationwide — enabling her to share reliable, up-to-date legal information with our readers.

This article has been written and reviewed for legal accuracy and clarity by the team of writers and legal experts at TruLaw and is as accurate as possible. This content should not be taken as legal advice from an attorney. If you would like to learn more about our owner and experienced injury lawyer, Jessie Paluch, you can do so here.

TruLaw does everything possible to make sure the information in this article is up to date and accurate. If you need specific legal advice about your case, contact us by using the chat on the bottom of this page. This article should not be taken as advice from an attorney.

Considering Filing an Onglyza Heart Lawsuit? Here’s What You Need to Know

June 15, 2018:

More than 200 Onglyza heart lawsuits are currently pending in 30 federal courts and have been centralized before Judge Curtis E.A. Karnow in the U.S. District Court, Eastern District of Kentucky.

Onglyza Lawsuit Diabetes Drug Linked to Heart Conditions; Onglyza Heart Failure Patient Awaiting Onglyza Lawsuit Settlement

The Onglyza lawsuit has been brought on behalf of individuals who allege that heart failure, and other cardiovascular events they experienced, were due to their use of the type 2 diabetes drug Onglyza (saxagliptin).

Table of Contents

What Is Onglyza?

Onglyza (saxagliptin) is an oral type 2 diabetes medication that works to control blood sugar levels by regulating the insulin levels the body produces after eating.

It is in the class known as gliptins (DPP-4 inhibitors).

Onglyza is manufactured by Bristol-Myers Squibb (BMS) and AstraZeneca Pharmaceuticals LP and was approved by the FDA in July 2009.

Onglyza is not used to treat type 1 diabetes and is not approved for use by anyone less than 18 years of age.

The drug is sometimes used in combination with other diabetes medications as part of a program of treatment that includes proper diet, exercise, and weight control.

DPP-4 inhibitors are in a relatively new class of oral diabetes drugs that are typically prescribed to patients with type 2 diabetes who have not responded well to other drugs, such as metformin and sulphonylureas.

Besides Onglyza, other drugs in this class include Januvia (sitagliptin), Galvus (vildagliptin), and Tradjenta (linagliptin).

Onglyza helps to control high blood sugar levels by increasing the amount of incretin in the body, prompting the pancreas to release insulin and decrease the body’s release of glucagon.

DPP-4 inhibitors like Onglyza inhibit natural enzymes from stopping the action of incretin, which allows for the stimulation of insulin to continue for a longer period of time than what usually occurs after someone has a meal.

Onglyza Linked To Heart Failure

On April 5, 2016, the FDA issued a drug safety communication for Onglyza and its sister medication Kombiglyze XR, as well as Nesina, Kazano, and Oseni, ordering that the medications’ labels include a warning for an increased risk of heart failure.

All of these medications fall under the DPP-4 class of drugs.

The agency also directed patients to contact their healthcare providers immediately should they experience shortness of breath during normal daily activities, trouble breathing while lying down, tiredness, weakness, fatigue, or weight gain with swelling in the ankles, feet, legs or stomach.

Cardiovascular disease causes most of the deaths among those with diabetes and for this reason, the question of cardiovascular safety for new drugs developed to treat type 2 diabetes, including Onglyza, is considered to be extremely important for public health.

For this reason, in December 2008, the U.S. Food and Drug Administration (FDA) issued guidance requiring drug companies to conduct studies to demonstrate that the new diabetes drugs do not increase cardiovascular risk.

Amid growing concern regarding the safety of the new diabetes drugs, in 2014 the FDA released a preliminary report discussing the results of the SAVOR-TIMI 53 clinical trial involving more than 16,492 type 2 diabetes patients.

The purpose of the study was to determine whether or not saxagliptin gave patients any heart protective benefits in addition to controlling blood sugar levels, but the report showed, which was published in the New England Journal of Medicine, that the patients taking Onglyza had a 27 % increased risk of hospitalization due to heart failure, and also a possible increased risk of death from all causes.

In this clinical trial, 3.5% of patients who received saxagliptin, were hospitalized for heart failure versus 2.8% of patients who received a placebo.

According to the FDA, the causes of death were “multifactorial,” meaning that the patients may have suffered from several serious medical conditions prior to their death.

Onglyza Linked to Pancreatitis and Pancreatic Cancer

In February 2013, researchers at Johns Hopkins found that people with type 2 diabetes hospitalized for pancreatitis were two times as likely to be on an incretin mimetic drug.

Pancreatitis can lead to pancreatic cancer.

Then in March 2013, a study published in the specialty journal Diabetes found that patients taking Onglyza had a pancreas 40% larger than normal.

The enlarged pancreas also contained more pre-cancerous growths and small tumors.

A “Dear Doctor” letter from Bristol-Myers Squibb and AstraZeneca on the UK Medicine and Healthcare Products Regulatory Agency’s website say:

“A review of reports of pancreatitis from post-marketing experience revealed signs of pancreatitis occurred after the start of saxagliptin treatment and then resolved after discontinuation, which is suggestive of a causal relationship.”

Pancreatitis has been recognized as an adverse event for DPP-4 inhibitors.

What Are The Side Effects Of Onglyza?

Side effects commonly associated with Onglyza use include:

  • headaches
  • gastroenteritis
  • severe nausea and vomiting
  • respiratory tract infections
  • urinary tract infections
  • severe pain in your upper stomach (that spreads to your back)
  • swelling of hands, ankles, feet
  • swelling of the face, lips, tongue, throat
  • signs of an allergic reaction which can include hives, red rash that causes blistering

Patients and medical professionals should be aware that Onglyza use could prompt episodes of low blood sugar levels (hypoglycemia).

Hypoglycemia can be experienced by anyone who suffers from diabetes, and symptoms include:

  • headache
  • hunger
  • sweating
  • paleness
  • irritability
  • dizziness
  • shakiness
  • trouble concentrating

What Is Type 2 Diabetes?

Type 2 diabetes is a chronic disease that affects approximately 27 million people in the U.S.

Although people with type 2 diabetes make insulin, their cells don’t use it as well as they should in order to handle the sugar in their blood –  this is known as insulin resistance.

While not everyone with type 2 diabetes is overweight, research has found that obesity, or a lack of physical activity, can cause insulin resistance, especially among those who carry extra weight in their midsection.

Type 2 diabetes can affect children and teenagers as well as adults, chiefly because of childhood obesity.

Onglyza Lawsuit

The Onglyza lawsuit makes similar allegations against drug makers Bristol-Myers-Squibb and AstraZeneca, charging that the companies:

  • Failed to warn consumers that Onglyza use can cause heart failure, cardiac failure, congestive heart failure, and death from heart failure.
  • Ignored December 2008 FDA guidance that urged drug makers to demonstrate that the new therapies wouldn’t result in an unacceptable risk of cardiovascular events.
  • Marketed and sold the medications for nearly five years before completing an adequate study of the cardiac risks associated with saxagliptin.
  • Conveyed untrue and distorted information concerning the safety and effectiveness of saxagliptin and concealed the risks of serious adverse events.
  • Actively concealed these risks from consumers and healthcare professionals.
  • Promoted and continue to promote Onglyza as a safe and effective treatment for type 2 diabetes patients.
  • Purposely delayed their efforts to change the labels and reference materials for saxagliptin to include a warning regarding increased risk of heart failure, congestive heart failure, cardiac failure, and death related to use of the medication.
  • The pending Onglyza lawsuits, as well as any Onglyza lawsuit filed in federal courts in the future, are being consolidated in U.S. District Court in the Eastern District of Kentucky, where they will undergo coordinated pretrial proceedings, including discovery. At some point, several representative cases will be chosen for a series of bellwether trials that are intended to provide insight as to how juries might decide similar lawsuits and as a potential pathway to faster settlements.

Frequently Asked Questions

  • How Do I Pick an Onglyza Lawyer?

    Onglyza lawsuits have been consolidated into a court in Lexington, KY for preliminary proceedings using the Mulitidistrict litigation (MDL)  process.

    Lawsuits that move into an MDL are generally complex and involve a number of plaintiffs, making the process of litigation these cases different than other injury lawsuits.

    For that reason, it is very important to consider whether the lawyer you chose to represent you in your Onglyza lawsuit has experience with the multidistrict litigation and has the resources to represent clients in a number of different states.

    TruLaw is not afraid to take on the largest drug and medical device companies in the world.

    We work with trusted legal affiliates to make sure that TruLaw clients have the resources and experiences needed to hold big business accountable when they put profits over people.

  • How Can an Onglyza Lawsuit Help?

    Your Onglyza lawsuit is designed to help you and/or your family financially recover from heart failure.

    We hope putting your trust in TruLaw will take away your concern of protecting your legal rights, but it is most important to us that you spend your time recovering physically and/or mentally.

    Your Onglyza lawsuit should assist in covering your medical bills, the amount of income and benefits that you lost as a result of your injury.

    In addition, it is always our hope that your lawsuit will help us to remove dangerous drugs, toxins and devices from the market.

    We hope to make the public more aware of Onglyza’s link to heart failure.

    We are not only lawyers, but also safety advocates that believe in getting information out to the public so no more people are injured.

    We hope you will join us in the role as a safety advocate.

  • Has There Been an Onglyza Settlement?

    One of the goals of setting up a multidistrict litigation (MDL) is to move forward with some sample trials that help to establish liability.

    These sample trials (referred to as the bellwether process) are generally used as a starting point for settlement discussions.

    Most MDLs settle.

    Onglyza lawsuits were consolidated into an MDL in February 2018.

    The bellwether trial schedule will be set up in due time and those cases selected will be fully prepared and tried to a jury.

    After that time, we expect to hear some discussion regarding Onglyza settlements.

    TruLaw will keep the public updated as to any settlement discussions as we learn of them.

  • Is there an Onglyza Class Action?

    We often hear injured people refer to their personal injury case as a “class action” because their case was grouped together in a lawsuit with other injured people.

    This is most often NOT the case.

    Often, individual cases are grouped together so the attorneys and judge can address common procedural issues initially, this tool is called multidistrict litigations (MDL).

    In February 2018, Onglyza lawsuits were grouped together into MDL number 2809 in the Eastern District of Kentucky and will be heard by Chief Judge Karen K. Caldwell.

    This is not a class action lawsuit – each plaintiff and injury is different and will be treated as such.

    But, preliminary decisions about the case will be made in the MDL so that this complex case can move forward quicker.

  • Is there currently an Onglyza Lawsuit?

    Yes.  Onglyza lawsuits have been filed on behalf of individuals who allege Onglyza, a type 2 Diabetes drug, caused their heart failure.

    On February 9, 2018, the United States Judicial Panel on Multidistrict Litigation ordered the consolidation of 84 Onglyza casesto the United States District Court, Eastern District of Kentucky, Central Division in Lexington under the Honorable Karen K. Caldwell.

    These cases will now be refer to as MDL number 2809.

    Although there may still be Onglyza cases filed in state courts, the majority of Onglyza lawsuits will move forward in this MDL, which is a procedural tool used to streamline the process of a complex case.

    TruLaw is pursuing Onglyza, Kombiglyza, Nesina, and Kazano lawsuits because we believe consumers were not properly warned of the risks of injury.

  • Have you seen or heard a Onglyza Commercial?

    Did a recent Onglyza or diabetes drug commercial grab your attention?

    Did you find our site because you were wondering if you qualify for Onglyza lawsuits?

    We built the Onglyza Instant Case Evaluator ℠ as a no cost/no obligation place for you to find answers about your legal rights.

    If you found us today, you are looking for instant answers to whether you should file a Onglyza, Kombiglyza, Nesina, or Kazano lawsuit and we want to help you.

    We believe that in order for you to make important decisions about your health and your legal rights, you need to start with information.

    We provide you this valuable information so you are prepared to talk to a lawyer.

Written By:
Jessie Paluch
Jessie Paluch

Experienced Attorney & Legal SaaS CEO

With over 25 years of legal experience, Jessie is an Illinois lawyer, a CPA, and a mother of three.  She spent the first decade of her career working as an international tax attorney at Deloitte.

In 2009, Jessie co-founded her own law firm with her husband – which has scaled to over 30 employees since its conception.

In 2016, Jessie founded TruLaw, which allows her to collaborate with attorneys and legal experts across the United States on a daily basis. This hypervaluable network of experts is what enables her to share reliable legal information with her readers!

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