Onglyza Lawsuit Guide
Patients who used Onglyza to control their diabetes are filing lawsuits after experiencing heart failure and pancreatic cancer. 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. This comes after countless people suffered serious injuries and were never made aware of the life-threatening side effects.
Many Americans are now facing a terrible choice: stopping their treatment and potentially fatal 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.
*Please seek the advice of a healthcare provider before discontinuing the use of this medication.
Medication Type: Diabetes
Injuries: Heart Attack, Pancreatic Cancer
Manufacturer: AstraZeneca, Bristol-Myers
Settlement Amounts: EST – $100,000 over $1,000,000
What Is Onglyza Used for?
Onglyza (saxagliptin) is an oral anti-diabetic drug manufactured by AstraZeneca and Bristol-Myers Squibb that was approved by the FDA in 2009. Kombiglyze XR is a combination of saxagliptin and metformin HCl (extended-release) and was approved in 2010. 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.
Onglyza and Kombiglyze Side Effects
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, Onglyza received an FDA warning that 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.
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. 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.
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.
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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.
Financial compensation and Settlements
Pharmaceutical companies who manufacture Onglyza such as AstraZeneca or Bristol-Myers Squibb often make millions by marketing dangerous drugs that have never been tested properly. Saxagliptin 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.
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 of the upcoming litigation trial will require lengthy depositions and adequate time. Our Onglyza lawyers’ strong legal skills and tireless determination will provide you with all the right weapons to fight this battle. With dozens of years of experience in this field, we know what’s the best approach to guide our clients to success.
Onglyza Class Action or Multidistrict Litigation?
Currently, only individual lawsuits have been filed against AstraZeneca’s medication Onglyza, thus, no Class Action litigation is available. On the other hand, since most mass tort proceedings are still very recent, no Multidistrict litigation has been consolidated yet. An MDL is usually centralized in order to eliminate any delay in the pretrial discovery phase and avoid conflicting rulings from different judges.
Litigations filed against drugs with properties similar to saxagliptin ones like Victoza, Byetta, Januvia, Nesina and Janumet have already been centralized in a Multidistrict Litigation in the Southern District of California overseen by the U.S. District Judge Anthony J. Battaglia. 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. 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.