Onglyza Lawsuit Information

Patients who used Onglyza to control their diabetes experienced a heart attack while others were diagnosed with pancreatic cancer caused by its side effects. The U.S. Food and Drug Administration (FDA) recently recommended new label warnings for this dangerous Type 2 diabetes medication, after more than seven years since it was originally approved. Many Americans are now facing a terrible choice: stopping their treatment and face life-threatening consequences, or keep taking AstraZeneca’s drug and risk its dangerous complications.

If you or your loved ones suffered from a pancreatic or cardiovascular disorder or any other adverse reaction after taking Onglyza, contact our attorneys today for a free consultation. There is no obligation, and we are here to assist you with expert legal advice on a 24/7 basis.

What is Onglyza?

Onglyza (saxagliptin) is an oral anti-diabetic drug manufactured by AstraZeneca and Bristol-Myers Squibb that was approved by the FDA in 2009 [1]. Kombiglyze XR is a combination of saxagliptin and metformin HCl (extended-release) and was approved in 2010 [2]. Both these drugs are used to help control hyperglycemia (high blood sugar) in people affected by type 2 diabetes, and may be used in combination with other oral hypoglycemic drugs such as sulphonylureas.

Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that acts by slowing down the breakdown of a group of hormones called incretins which help the production of insulin. A higher level of these incretins in the body improves blood glucose regulation after meals as well as decreasing the production of newly formed glucose in the liver (gluconeogenesis). Incretins’ activity is proportional to blood sugar levels, so the risk of hypoglycemia (dangerously low blood glucose) is lower than with other similar drugs [3].

Why are Onglyza and Kombiglyze dangerous medications?

Several clinical trials pointed out that the use of saxagliptin is associated with a life-threatening risk of heart failure. This side effect is so severe that in April 2016, the FDA changed the medication’s label to add a new warning after a safety review was issued. 14 out 15 members of the Endocrinologic and Metabolic Drugs Advisory Committee voted in favor of the updated label, while the last member of the board recommended a full product recall since he deemed it too dangerous for the U.S. market [4]. On October 2013, a first study published in the New England Journal of Medicine found a 27 percent increase in heart failure hospitalizations in diabetic patients who took the DDP-4 inhibitor [5]. Data analyzed included more than 16,000 subjects from the SAVOR TIMI-53 trial, which was funded by AstraZeneca and Bristol-Myers Squibb. Two large systematic meta-analyses published in 2014 confirmed the risk, which may even be greater in some sub-populations of patients [6, 7].

Additionally, this medication as well as several other incretin mimetic drugs such as Victoza (liraglutide), Byetta (exenatide), Januvia (sitagliptin), Nesina (alogliptin) and Janumet (sitagliptin and metformin) have been associated with dangerous pancreatic disorders. Incretin therapy may result in an expansion and proliferation of pancreatic compartments, which may lead to a chronic inflammation process (pancreatitis) that may evolve into a neuroendocrine tumor (pancreatic cancer). Since both of this condition may present itself with few symptoms during their early stages, patients are thus exposed to a higher risk of pancreatic malignancies that may require a surgical resection of the whole organ [8, 9].

Onglyza and Kombiglyze life-threatening adverse reactions

Did you take Onglyza and suffer from heart failure or any other serious complication? Fill out our Free Case Review form to find out your possible legal options.

  • Heart failure
  • Pancreatitis
  • Pancreatic cancer
  • Severe joint pain
  • Lactic acidosis
  • Unexplained weight loss
  • Nausea or vomiting
  • Blood in the urines
  • Jaundice

Why should I file an Onglyza lawsuit?

Pharmaceutical companies such as AstraZeneca or Bristol-Myers Squibb often make millions by marketing dangerous drugs that have never been tested properly. Onglyza reached $786 million in sales in 2015, an outstanding amount of money that can reach up to $2.47 billion in 2018 according to market analysts [10]. Suffering an injury because a Big Pharma never warned you or your loved one about its risk is unacceptable. You may have to face significant financial loss as well as physical and emotional injuries as well. Filing a lawsuit is not only necessary to provide you with the monetary means to cover your expenses, but to prevent other people from suffering the same fate by holding the manufacturer liable for all their crimes. Finding the best lawyer who can handle your case and provide you with the highest compensation possible if of the utmost importance. It should be enough to pay the past and future medical bills and account for all the working day lost, as well as all the personal damage and pain you suffered.

Often the pharmaceutical companies offer out of court negotiation to shut down the litigations before the legal system is involved. The pre-trial discovery phase can require lengthy depositions and stressful out-of-pocket expenses to cover traveling to a different city or state. An experienced pharmaceutical injury lawyer can ensure you will discuss with you what’s the best strategy to get the highest monetary settlement with the less stress involved. Our lawyers’ strong legal skills and tireless determination will provide you with all the right weapons to fight such an imposing foe as a pharmaceutical company in court. With dozens of years of experience in this field, we know what’s the best approach to guide each one of his clients to success, including you.

Damages for which you could receive monetary compensation

  • Lost income and wages
  • Emotional distress
  • Psychological trauma
  • Pain and suffering
  • Personal injuries
  • Medical expenses (past, present and future)
  • Loss of companionship
  • Funeral expenses
  • Wrongful death
  • Punitive damages

Plaintiffs principal accusations against pharmaceutical companies

  • Falsely advertising their product despite having knowledge of inherent dangers
  • Failure in warning doctors and patients about dangerous adverse reactions
  • Failure in conducting adequate pre-market trials
  • Negligently or fraudulently marketing their medication
  • Marketing a defective or harmful drug according to the product liability law
  • Conspiracy and malicious conduct

Gibson v. AstraZeneca Pharmaceuticals LP

On October 29, 2015, Rochelle Gibson, a resident of Chicago, filed a litigation against AstraZeneca Pharmaceuticals in Cook County Circuit Court (Case No. 2015-L-010969). The woman is accusing the pharmaceutical company of negligence for failing to warn the public about the risks of their dangerous medication, on behalf of her mother, Lillie Ree Gibson. According to the complaint, Mrs. Gibson died of a cardiovascular attack on October 31, 2013, while she was hospitalized. She was diagnosed with heart failure in June 2011, shortly after her doctor prescribed her saxagliptin to treat her diabetes [11].

Is my case going to be included in an Onglyza Class Action or a Multidistrict Litigation?

Currently, only individual litigations have been filed against AstraZeneca, thus, no Class Action is available. Also, since most proceedings are still very recent, no Multidistrict litigation has been consolidated yet, although there’s a strong chance it will be as soon as the total number of lawsuits filed increase. An MDL is usually centralized in order to eliminate any delay in the pretrial discovery phase and avoid conflicting rulings from different judges. However, saxagliptin’s mechanism of action shares many similarities with other incretin mimetic drugs such as Victoza, Byetta, Januvia, Nesina, and Janumet. All those drugs have been associated with a risk of pancreatic cancer and pancreatitis, and many patients complained in courts through the country alleging that the manufacturers of these drugs did not properly warn the public about this risk. In August 2013, a large number of plaintiffs’ pending cases have been centralized in a Multidistrict Litigation in the Southern District of California, before U.S. District Judge Anthony J. Battaglia. Although Onglyza is not officially part of this list, it is possible that new cases of pancreatic disorders where this DPP-IV inhibitor may have had a causative role are included among the about 800 allegations in the MDL no. 2452 due to the pharmacological similarities. Lawsuits filed by patients who suffered other types of damage will be kept separate, instead [12, 13].

Article written by: Dr. Claudio Butticè, Pharm.D.