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Over 37 million Americans grapple with diabetes, constituting over 10% of the population. Notably, approximately 95% Americans are affected by Type 2 diabetes. Globally, ongoing research and innovations aim to discover effective solutions for diabetes management.
Many medications were developed to treat Type 2 diabetes, which were also used off-label for weight loss in people with or without diabetes. However, when these drugs come with hidden health risks, which over shadow the benefits, patients are at peril. One such medication is Byetta.
Through this blog, we are going to analyze the side effects of Byetta and the status of Byetta weight loss drug lawsuits.
What is Byetta?
Byetta, a medication for treating Type 2 diabetes, was first approved in April 2005 by the U.S. Food and Drug Administration (FDA). Developed by Amylin Pharmaceuticals and Eli Lilly & Co., it marked the debut of the GLP-1 receptor agonist and incretin mimetics class of drugs.
Byetta, a groundbreaking medication for Type 2 diabetes, was made with exenatide, a member of the glucagon-like peptide-1 (GLP-1) agonist and incretin mimetics drug class. Administered through a prefilled injection pen with strengths of 5 mcg and 10 mcg, Byetta injection is to be administered twice-daily before main meals. The pen had 60 doses of exenatide. It was sold under the brand name Byetta and did not have any generic version of the drug.
The extended-release version of Byetta, known as Bydureon BCise, is a weekly injection. It comes in a 2 mg single-use auto-injector pen.
How does Byetta work?
Byetta functions by enhancing insulin release from the pancreas post-meal and reducing sugar production by the liver. It slows digestion, thereby reduces sugar absorption from food and decreases appetite.
The drug is injected under the skin (subcutaneous) in the arm, abdomen, or thigh, and must not be administered after meals. It is one of the treatment options after using metformin and sulfonylureas.
Though Byetta is approved for diabetic treatment, it is widely used off-label for weight loss. Byetta users have found significant weight loss during the Byetta use. Since obesity and diabetes are somewhat interlinked, weight loss during the drug administration helps the users a lot. Weight loss occurs from the Byetta’s role in slowing down the digestion process and creating a feel of fullness.
Journey of Byetta- from Amylin to AstraZeneca
Byetta was developed by Amylin Pharmaceuticals and Eli Lilly & Co. In November 2009, it was again approved for the expanded use as first-line treatment for Type 2 diabetes and in October 2011, for use with insulin Glargine.
In the same year, a study was published in the medical journal, Gastroenterology by the researchers from the University of California. It identified that there was a 3-time increase in the pancreatic cancer reports and a 6-tme increase in pancreatitis among the Byetta users. They identified thyroid cancer risk too.
Many other studies also started linking necrotizing pancreatitis or hemorrhagic pancreatitis, can cause severe bleeding, multi-organ failure or death from Byetta.
Pancreatitis side effects from Byetta first surfaced in 2007 with more than 30 cases reported to the FDA. FDA issued an alert to the physicians and the consumers of Byetta. In August 2008, six more cases including 2 deaths were reported and AstraZeneca disclosed that they too were aware of 4 more deaths from pancreatitis among the users of Byetta.
From April 2005 to October 2008, the FDA received around 78 reports of Byetta kidney issues.
In June 2012, Bristol-Myers Squibb Company and AstraZeneca acquired Amylin for $5.3 billion. In March 2014, they received the FDA approval for Bydureon pen, an extended-release version of exenatide to treat Type 2 diabetic patients.
Byetta and Weight Loss
In a meta-analysis done among the overweight and obese people without diabetes, Byetta use has proved to reduce around 10 pounds on average in 3 to 6 months after the Byetta initiation. The users found reduction in their waistline by an inch, as the study published in the International journal of Cardiology.
A PubMed study identified that Byetta could achieve weight loss similar to those who followed hypo caloric diet. This study by Dr. Jody Dushay and colleagues at Beth Israel Deaconess Medical Center involved obese women without diabetes. Published in December 2011 in Diabetes Care, the research revealed that these women began shedding weight within two weeks, with an average loss of 5.5 pounds after 16 weeks.
The mechanisms behind Byetta’s potential weight loss effects are not fully understood. Researchers propose that the drug might impact energy expenditure, induce nausea to reduce food intake, or enhance leptin sensitivity. Leptin is a hormone influencing hunger and signaling satiety, and its sensitivity tends to be lower in obese individuals.
Despite these findings, it’s crucial to note that the FDA has not granted approval for Byetta as a weight loss solution. Additionally, there’s a lack of long-term studies on the safety of exenatide use for weight management in individuals without diabetes. The intersection of Byetta and weight loss remains an area of interest with potential implications for broader applications.
Adverse Side Effects of Byetta
According to the Byetta side effects noted in the AstraZeneca’s website, confusion, dizziness, drowsiness, fast heartbeat, feeling jittery, headache, hunger, irritability, sweating, and weakness are some of the most common side effects that can occur due to the Byetta use.
The serious side effects mentioned in their website include,
- Pancreatitis (inflammation of the pancreas)
- Dehydration from nausea, vomiting and/or diarrhea
- Risk of kidney issues
- Severe allergic reaction or angioedema (swelling of the face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting, very rapid heartbeat)
- Thrombocytopenia (low blood platelets)
The side effects noted in the adverse event reports, researches and the Byetta weight loss drug lawsuits pointed out the following:
- Acute pancreatitis
- Chronic pancreatitis
- Hemorrhagic pancreatitis
- Necrotizing pancreatitis
- Pancreatic inflammation
- Pancreatic cancer
- Thyroid cancer
- Kidney damage
- Low blood-sugar (hypoglycemia)
- Decreased appetite
Was Byetta taken off the market after the allegations of cancer?
Byetta was not taken off the market. In 2007, followed by the warning by the FDA, the labels were modified to include the risks including pancreatitis, pancreatic cancer and thyroid tumor. It is still available.
Byetta Weight Loss Drug Lawsuits
Though Byetta lawsuits were filed individually, due to their common factors of causing pancreatic cancer, it was consolidated along with the lawsuits against Januvia, Janumet, and Victoza in a federal court in California.
Hundreds of lawsuits have been filed against the makers of certain diabetes drugs, including Merck & Co. (Januvia and Janumet), Amylin and Eli Lilly and Co. (Byetta), and Novo Nordisk (Victoza). Centralization was deemed more efficient due to all lawsuits claiming the drugs caused pancreatic cancer and pancreatitis, leading to shared expert testimony and discovery processes.
Nearly 950 lawsuits involving Januvia, Janumet, Byetta, and Victoza were consolidated in multidistrict litigation (MDL) No. 2452, titled In Re: Incretin Mimetics Products Liability Litigation, in 2013.
In August 2014, AstraZeneca stated that it had come to a settlement agreement in dozens of Byetta weight loss drug lawsuits.
In response to the lawsuits, defendants argued preemption, contending that failure-to-warn claims should be dismissed because the FDA would not have approved a label warning for pancreatic cancer. In 2015, U.S. District Judge Anthony J. Battaglia granted the manufacturers’ request to dismiss all cases in the MDL, citing clear evidence that the FDA would have rejected such label changes. The concept of preemption holds that state law can’t impose requirements in federally regulated areas.
After relentless works of lawyers, the U.S. Court of Appeals for the Ninth Circuit court reinstated these lawsuits including Byetta weight loss drug lawsuits, leading to the reopening of the MDL in December 2017. The cases were redirected to U.S. District Judge Anthony Battaglia (Southern District of California).
As of September 17, 2018, there were 948 cases pending in the reopened MDL. However, the judge dismissed the most of the cases again in 2021 claiming that there was not much evidence to prove that these drugs caused cancer.
In late 2022, when the MDL was closed, there were 469 unresolved cases.
Allegations in MDL Lawsuits
The MDL lawsuits against manufacturers of Januvia, Janumet, Byetta, and Victoza encompass several key allegations:
- Claimed that the formulation of these drugs increased the risk of pancreatic cancer.
- Alleged of defective drugs causing “unreasonable and dangerous side effects.”
- Accusations that manufacturers failed to adequately test and monitor side effects before marketing the drugs.
- Asserted that drug makers should have known about the risks but didn’t adequately warn doctors or patients.
- Accused of concealing the risks of pancreatitis and pancreatic cancer from healthcare providers and the public.
- Claimed that the drugs’ labels lack specific warnings about pancreatic cancer.
- Asserted that current warnings for Januvia, Janumet, Byetta, and Victoza are inadequate.
The case studies reported by Drug watch are discussed below:
Linda Jean Howard
Linda filed her federal lawsuit in August 2013 against Bristol-Myers Squibb for her acute pancreatitis from using Byetta and Victoza. Her lawsuit alleged that had she known the risks of pancreatic cancer and pancreatitis, she would not have taken the drug. Her Byetta lawsuit alleged that the manufacturer failed to adequately test and monitor the drug complications, concealed the pancreatic cancer and pancreatitis risks from the physicians and public, and did not include the pancreatic cancer in the warning labels.
Regina Kelly developed pancreatic cancer after using the drugs Januvia and Byetta. The adverse side effects of the drugs led her to develop cancer, which subsequently ended in her demise. Her estate filed a wrongful death lawsuit for her untimely death from these drugs.
Byetta weight loss drug lawsuits hint at the importance of thorough drug testing and transparent reporting of potential risks. For patients, it is a call to be vigilant and informed decision about the medications they use, and for healthcare providers, a reminder of the critical role they play in monitoring drug safety.