Byetta Lawsuit

Type 2 diabetes drug Byetta helped usher in a new class of drugs aimed at helping improve blood sugar control that worked differently than drugs on the market at the time. Some clinical researchers said that the glucagon-like peptide-1 receptor agonist changed the landscape of diabetes treatment completely.

While Byetta was a very different drug when it was introduced in 2005, hundreds of patients taking the medication since its debut have experienced unforeseen side effects of pancreatitis and pancreatic cancer. Many were hospitalized for their symptoms, and some even died of the complications researchers have linked to the diabetes drug.

Due to the previously unknown side effects, patients have filed lawsuits against the maker of Byetta with claims that the company hid the risks from the public, failed to test Byetta’s safety properly, and made a defective drug.

Nearly a thousand cases against Byetta and similar type 2 diabetes drugs are currently pending in a federal court in California. Learn more about Byetta and what the lawsuits claim.

How Byetta Works

Byetta, whose active ingredient is exenatide, is part of a group of drugs called glucagon-like peptide-1 (GLP-1) receptor agonists. It comes in a pen injector device that a patient administers twice a day — once before the first meal of the day and once before the last meal of the day.

GLP-1 is a hormone that can decrease blood sugar levels by increasing the secretion of insulin in the body. Exenatide works by mimicking the behavior of GLP-1 to naturally lower blood sugar levels and enhance the secretion of insulin. It essentially stimulates insulin production from the pancreas, regulates glucose levels, reduces the intake of food, and slows the rate of gastric emptying.

The drug is prescribed in conjunction with diet and exercise to improve glycemic control in those with type 2 diabetes.

Whereas Byetta is given twice a day, a more recent formula of exenatide called Bydureon is only administered once a week.

Byetta has been noted by the American Diabetes Association and the European Association for the Study of Diabetes (EASD) for the drug’s ability to promote weight loss without increasing hypoglycemia, according to the drug fact sheet1.

Background of Byetta

In April 2005, Amylin Pharmaceuticals and Eli Lilly and Company announced that Byetta was approved by the U.S. Food and Drug Administration to improve blood sugar control in type 2 diabetes patients who have not been able to improve control with other medications.

Byetta’s active ingredient exenatide was also the first in a new class of drugs called incretin mimetics.

“BYETTA offers an exciting new option for people with type 2 diabetes and marks an important milestone for Amylin and Lilly’s successful collaboration,” said Sidney Taurel, Chairman and Chief Executive Officer of Eli Lilly and Company at the time, said in a 2005 press release2. “With BYETTA’s demonstrated effects on blood sugar and its safety profile, physicians and patients now have a new approach to fight the growing diabetes epidemic.”

Upon its announcement, news outlets focused on the origin of the diabetes shot, which was derived from the poisonous Gila monster found in the southwestern United States. In a 10-year anniversary piece from the new maker of Byetta, AstraZeneca talked up the importance of the drug at the time3.

“At the time of its launch, BYETTA was considered the most innovative new type 2 diabetes products since the early 1990s,” Curtis Carter, Director of Advocacy, AstraZeneca, said. “The response from the physician and advocacy community was tremendous. Everyone was excited about the approval because they knew BYETTA offered another critical treatment option that could help a large number of adults with type 2 diabetes manage the condition.”

In the following years, Byetta was approved for expanded use by the FDA and another version of exenatide called Bydureon was approved in 2012.

By 2012, Byetta had generated billions in sales. This prompted Bristol-Myers Squibb and AstraZeneca to purchase Amylin Pharmaceuticals for approximately $7 billion4. AstraZeneca later bought Bristol-Myers Squibb’s global diabetes division that included Byetta for more than $4 billion.

Serious Byetta Side Effects

Byetta comes with a warning of common but mild side effects reported among patients taking the drug. However, not long after Byetta was released, reports of more severe side effects in those prescribed the drug started appearing.

One of the most severe complications associated with Byetta is pancreatitis or inflammation of the pancreas. Within two years of Byetta’s release, the FDA had received 30 postmarketing reports of acute pancreatitis in patients taking the drug. Twenty-one patients required hospitalization and five developed serious complications, such as dehydration and kidney failure.

This evidence prompted the FDA to issue a warning to healthcare professionals that the use of exenatide may be linked to a risk of pancreatitis. The FDA asked Amylin Pharmaceuticals to include information about pancreatitis in the precautions section of the drug label5.

Studies backed up the connection between Byetta and pancreatitis. One 2011 study found that patients taking exenatide or sitagliptin were six times more likely to report pancreatitis than those undergoing other type 2 diabetes therapies6.

Byetta and Cancer

Byetta is also connected to a higher incidence of pancreatic cancer, a highly deadly form of cancer with a low survival rate.

Reports to the Drug Commission of the German Medical Association noted a higher rate of pancreatic cancer in those taking Byetta. There was an average of 12.2 months between the start of treatment with exenatide and the diagnosis of pancreatic cancer in the reports found in connection with Byetta.

A 2011 study also found a connection to pancreatitis and pancreatic cancer6.

“These data are consistent with case reports and animal studies indicating an increased risk for pancreatitis with glucagon-like peptide-1-based therapy,” the authors concluded. “The findings also raise caution about the potential long-term actions of these drugs to promote pancreatic cancer.”

In 2013, the FDA announced it was evaluating unpublished new findings that suggest an increased risk of pancreatitis and pre-cancerous cellular changes in those taking incretin mimetics. The FDA did not reach any conclusions at the time7.

Hundreds File Byetta Lawsuits

Because the consequences of Byetta side effects are so severe, hundreds of victims who took Byetta and related diabetes drugs filed lawsuits against the manufacturers.

By August 2013, at least 50 cases against Amylin and other drugmakers were filed in state courts around the country. Since they all dealt with similar questions of fact, the lawsuits were consolidated into multidistrict litigation in federal court to improve the efficiency of the lawsuits.

Many of the plaintiffs had taken Byetta along with other drugs associated with pancreatitis and pancreatic cancer like Januvia, Janumet, and Victoza. Plaintiffs in these cases alleged that the makers developed a defective drug with dangerous side effects, failed to test the safety of the drugs before selling them, knew about the risks but hid them from the public, and continue to downplay the risks.

Plaintiffs in these cases had a temporary setback before getting back on track in 2017. Nearly a thousand cases are currently pending in the MDL in Southern California8.

Those who have been diagnosed with pancreatitis or pancreatic cancer while undergoing treatment with Byetta may be eligible to receive compensation for medical expenses and more. Contact a qualified attorney today to get the justice you deserve.