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Byetta Lawsuit

Byetta Lawsuit

Byetta is a popular injection medication that helps people with type-2 diabetes control blood-sugar levels. Unfortunately, new research has linked it to increased risks of thyroid cancer and pancreatic cancer.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Byetta induced injury cases in all 50 states. If you or somebody you know has been diagnosed with thyroid or pancreatic cancer, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

Byetta Lawsuit Settlements

In August 2015, AstraZeneca and Amylin Pharmaceuticals agreed to an undisclosed settlement in 84 lawsuits involving Byetta and Bydureon. Terms of the settlements were not disclosed, but the drug-makers are facing hundreds of lawsuits involving pancreatitis, pancreatic cancer, and thyroid cancer.

Over 750 Lawsuits Centralized in Federal MDL

In August 2013, federal judges centralized about 50 lawsuits involving incretin therapy diabetes drugs like Byetta, Januvia, and Victoza. The lawsuits are now pending in a Multi-District Litigation (MDL No. 2452) in the U.S. District Court for the Southern District of California. Plaintiffs say Byetta caused their pancreatic cancer or the wrongful death of a family member. As of February 2016, there were 767 lawsuits still pending in MDL under Judge Anthony Battaglia.

Study Links Byetta and Pancreatic Cancer

In March 2013, the FDA published a Safety Communication about a study that found a potential risk of pancreatic cancer. Researchers at UCLA’s Medical School autopsied pancreases of people with diabetes who died of strokes and head injuries. About half of the people had used incretin drugs for at least one year (7 on Januvia and 1 on Byetta).

Researchers found that all of the people with diabetes who used incretin drugs for more than a year had very abnormal pancreases. The abnormalities included excessive amounts of beta-cells arranged in “eccentric” islets that were proliferating into the pancreatic ducts.

The people on incretin drugs also had tiny glandular tumors (microadenomas) throughout their pancreases. None of the people with diabetes who did not take incretin drugs displayed these abnormalities. Furthermore, the abnormalities were associated with pancreatitis.

In the patient on Byetta, the tumors were adenomas, which means they start benign but can become cancerous. Since the tumors can cause pancreatic cancer, treatment is usually immediate surgery. The problem is that pancreatic cancer is rarely diagnosed early in people with diabetes because one of the first symptoms is rising blood-sugar levels, which is normal for diabetics.

The study is 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. Alexandra E Butler et al. Published online before print March 22, 2013, doi: 10.2337/db12-1686. Diabetes March 22, 2013

Experts Raise Concern About Lack of Warnings

Soon afterward, the British Medical Journal published editorial describing the growing number of studies linking new diabetes drugs to pancreatic cancer. Experts are concerned about the lack of warnings regarding the risk. The American Diabetes Association (ADA) has also asked the manufacturer of Byetta to provide patient-level data on the risk of pancreatic cancer.

The Schmidt Firm, PLLC Files First Byetta Lawsuit

In August 2008, Michael E. Schmidt of The Schmidt Firm, PLLC has filed the first Byetta lawsuit in the United States on behalf of a man from Virginia who suffered pancreatitis after using Byetta. The complaint was filed in San Diego Superior Court, where drug-maker Amylin Pharmaceuticals is headquartered. It alleges that the company did not adequately warn physicians or the public about the risk of using Byetta.

What is Byetta?

Byetta (exenatide) is a type-2 diabetes medication manufactured by Amylin Pharmaceuticals in collaboration with Eli Lilly & Co. It comes in a pre-filled pen that patients inject twice a day. It was approved by the FDA in 2005 to be used with diet and exercise to help control blood-sugar levels. In 2012, the FDA approved a once-weekly, extended-release version of Byetta called Bydureon.

How Does Byetta Work?

Byetta contains a synthetic compound that was developed from a hormone called extendin-4, which is found in the poisonous saliva of the Gila monster, a large species of lizard that is native to the American Southwest and some parts of Mexico. This hormone is very similar to a hormone in the human digestive tract known as GLP-1, which triggers the production of insulin. However, extendin-4 lasts longer than GLP-1, which helps a diabetic control their blood sugar levels. Byetta also decreases cravings for food, which can help with weight loss.

Study Investigates Pancreatic/Thyroid Cancer Risk

Byetta was linked to a 2.9-fold increased risk of pancreatic cancer and a 4.7-fold increased risk of thyroid cancer in a study published in 2011 in the journal Gastroenterology. The study was conducted by researchers at UCLA and based on data from adverse event reports submitted to the FDA between 2004 – 2009. Soon afterward, letters written by two drug companies pressured Gastroenterology into withdrawing the study. Drug-makers were concerned that the researchers’ conclusions were unjustified and might spark an unnecessary health scare.

Byetta and Pancreatic Cancer

Pancreatic cancer is one of the most serious side effects that any medication can have, because it is often fatal. One reason why pancreatic cancer is so difficult to treat is because it does not have symptoms in its early stages. By the time a patient goes to the doctor and is diagnosed, only 20% of patients can have the cancer surgically removed. Less than 5% of people with pancreatic cancer survive more than five years.

Byetta and Thyroid Cancer

Thyroid cancer occurs when cells begin dividing out of control in the thyroid, a butterfly-shaped gland located in the lower-front part of the neck. Most cases of thyroid cancer are diagnosed early, and therefore the cure rates are very good. Treatment typically involves removing the entire thyroid gland. However, in some cases, thyroid cancer can return and spread to other areas of the body.

Byetta and Pancreatitis

In February 2013, a study published in JAMA Internal Medicine linked Byetta and other GLP-1 diabetes drugs to a doubled risk of pancreatitis. The first FDA warning about acute pancreatitis was published in October 2007, soon after the FDA received 30 reports of the side effect in Byetta patients.

Less than one year later, the FDA updated the warning to report 6 more cases of hemorrhagic and necrotizing pancreatitis — the most severe forms of the disease. The majority of these patients required hospitalization, and at least 6 deaths were linked to pancreatitis.

Byetta and Kidney Failure

The FDA warned about the risk of kidney failure from Byetta in the 2009. According to the Safety Communication, the FDA received 78 cases of “altered kidney function” between April 2005 and October 2008. Of these cases, 62 people suffered sudden kidney failure, and 16 people suffered kidney damage (renal insufficiency). Nearly all of the patients (91%) required hospitalization. Unfortunately, 4 deaths were linked to kidney failure, and only 39 (50%) of the patients had improved kidney function after they stopped using Byetta.

FDA Orders Drug-Maker To Study Risks

In October 2009, the FDA responded to numerous reports of severe side effects by issuing a Risk Evaluation and Mitigation Strategy (REMS). They decided to require Amylin Pharmaceuticals, Inc. to conduct six post-marketing safety studies to help better understand the link between Byetta and thyroid cancer, pancreatic cancer, and other serious side effects.

Side Effects of Byetta

  • Pancreatitis
  • Thyroid cancer
  • Pancreatic cancer
  • Kidney damage
  • Kidney failure, renal impairment
  • Death

Do I have a Byetta Lawsuit?

The Schmidt Firm, PLLC is currently accepting Byetta induced injury cases in all 50 states. If you or somebody you know has been diagnosed with thyroid or pancreatic cancer, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

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