Byetta is an injectable prescription drug designed to treat type 2 diabetes in adults by improving blood sugar control. At the time of its launch, the drug was hailed as one of the most innovative new drugs to treat type 2 diabetes in more than a decade.
But, since its initial approval by the U.S. Food and Drug Administration in 2005, Byetta has been linked to potentially deadly side effects, including pancreatitis and cancer. Hundreds of patients injured by Byetta and similar type 2 diabetes drugs have filed lawsuits against drug manufacturer Amylin Pharmaceuticals and other drugmakers over claims that they knew about the risks but failed to warn patients and doctors.
Find out more about how Byetta works, its possible side effects, and the status of the lawsuits.
Byetta was the first of a new class of drugs called glucagon-like peptide-1 (GLP-1) receptor agonists. The active ingredient exenatide belongs to a group of incretin mimetic drugs designed to treat type 2 diabetes. Byetta is an injectable medication administered twice daily to control blood sugar.
Manufactured by Amylin Pharmaceuticals, the drug was first approved for use in the United States by the FDA in April 2005. The FDA also approved another exenatide injection in January 2012 called Bydureon that only needs to be administered once a week.
Bristol-Myers Squibb purchased Amylin Pharmaceuticals in 2012. The next year, AstraZeneca acquired the diabetes venture of Bristol-Myers Squibb and became the owner of Byetta and Bydureon.
Since its debut, Byetta has brought in billions of dollars in sales.
In conjunction with exercise and a healthy diet, Byetta helps the user improve blood sugar control. It works by acting as a GLP-1 receptor, which enhances insulin secretion. According to the prescribing sheet1, Byetta “enhances glucose-dependent insulin secretion by the pancreatic beta-cell, suppresses elevated glucagon secretion, and slows gastric emptying.”
All of these functions work in concert to respond to higher levels of blood sugar with an increase in insulin production.
Byetta is meant to be taken twice a day — before the morning meal and before the evening meal — via injectable pen. Patients usually start with 5 mcg per dose twice a day before increasing to 10 mcg per dose twice a day after about a month.
Like all drugs, Byetta comes with a warning of several common side effects. The most common side effects include2:
Since its release in 2005, Byetta has been linked to cases of pancreatitis. According to the National Institute of Diabetes and Digestive and Kidney Diseases, pancreatitis is the inflammation of the pancreas that can lead to more severe complications, such as kidney failure3.
In 2007, the FDA warned healthcare professionals that exenatide may be linked to acute pancreatitis. The warning was based on 30 postmarketing reports of acute pancreatitis in those taking Byetta. In 21 cases, patients needed hospitalization for their symptoms. Five patients developed severe complications.
Several studies published in the following years made similar connections between Byetta and pancreatitis. A 2013 study published in JAMA Internal Medicine analyzed an extensive database of the United States in search of those with type 2 diabetes4. The case-control study revealed a connection between specific type 2 diabetes medications and hospitalization for acute pancreatitis.
“In this administrative database study of US adults with type 2 diabetes mellitus, treatment with the GLP-1-based therapies sitagliptin and exenatide was associated with increased odds of hospitalization for acute pancreatitis,” the authors concluded.
Not only did studies find that Byetta was linked to pancreatitis, but researchers also connected the drug with pancreatic cancer.
A 2010 study in Diabetes Care concluded that GLP-1 drugs like Byetta were not as safe as previously thought and may induce pancreatitis and pancreatic cancer5.
“We feel that enough preliminary evidence has accumulated to suggest that there is a plausible risk that long-term recipients of GLP-1–based therapy may develop asymptomatic chronic pancreatitis, and worse, subsequently a minority of individuals treated by this class of drugs may develop pancreatic cancer,” the authors wrote.
The following year, the authors of a study in Gastroenterology cautioned that the use of glucagon-like peptide-1-based therapy could have potential long-term actions that promote pancreatic cancer6.
In 2013, the FDA announced it was evaluating new unpublished findings that suggested an increased risk of pancreatitis and pre-cancerous cellular changes in those treated with incretin mimetic drugs like Byetta. The FDA did not draw any conclusions but issued an early communication to inform the public about the new information.
Even though the FDA has yet to draw any conclusions about Byetta and pancreatic cancer, hundreds of patients who have taken incretin mimetic drugs have filed lawsuits against the makers of these drugs.
In one case, a man filed a lawsuit against Amylin Pharmaceuticals before it was taken over by AstraZeneca over claims that his wife developed pancreatic cancer after taking Byetta and another type 2 diabetes drug. She later died from cancer.
The case was not dissimilar to hundreds of others against the makers of Byetta and other incretin mimetic drugs.
Many plaintiffs in lawsuits claim that Byetta was defective and its maker concealed the risks of pancreatitis and pancreatic cancer from the public and should have known about the side effects. Plaintiffs also allege that the current warnings for Byetta do not adequately reflect the increased risk of pancreatitis and pancreatic cancer.
In cases of defective drugs, attorneys typically do not pursue a class-action lawsuit against a drug manufacturer but will usually pursue a personal injury claim. If enough people file lawsuits with similar legal claims and questions of fact, the cases will be consolidated into multidistrict litigation (MDL) to speed up the process of complex cases.
More than 50 cases against the makers of these drugs were centralized in an MDL in the U.S. District Court for the Southern District of California in 20137.
Although the defendants were granted a summary judgment over federal preemption, plaintiffs petitioned to vacate the ruling. A judicial panel agreed to proceed with the MDL in late 2017.
As of August 2018, there were 945 cases still pending in the MDL against the makers of Byetta and other incretin mimetic drugs.
Byetta has been used by millions of people around the world. Although many have used Byetta without issue, the drug may be responsible for many diagnoses of pancreatitis and pancreatic cancer.
Those who have experienced unexpected complications related to pancreatitis and pancreatic cancer after taking Byetta do not need to suffer alone. If you or a loved one were injured while taking Byetta, you may be eligible for compensation. Contact an attorney today to find out more.
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