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Byetta

The Byetta injury lawyers at the Drug Law Center are currently investigating cases where patients have suffered serious harm or died prematurely after taking the Type II diabetes treatment medication.

Introduction

Byetta Drug RecallByetta (exenatide) is an injectable synthetic glucagon-like peptide-1 receptor agonist prescription drug used to control blood sugar levels in adults suffering from Type II diabetes. Doctors prescribe the medication to be used concomitantly with exercise and a healthy diet. The drug is effective because it assists the pancreas in producing insulin more efficiently.

The History of Byetta

The injectable diabetes treatment drug Byetta is manufactured by Amylin Pharmaceuticals and Eli Lilly & Co. The FDA (Food and Drug Administration first approved Byetta in April 2005 to treat Type II diabetes mellitus. The medication is designed to be injected subcutaneously (under the skin) in the arm, leg or abdomen within one hour before consuming breakfast and dinner. In January 2012, the drug maker got approval from the FDA further once-weekly injection that is sold under the brand-name Bydureon.

While the product has proven to be beneficial to Type II diabetic patients, it has produced severe side effects including harm to the gastrointestinal tract. In 2007, the FDA required an additional warning on the Byetta Black box warning label to include death a correlation between taking the medication and reports of acute pancreatitis. The following year, the FDA received reports that four patients had died from pancreatitis after being prescribed Byetta. Since then, concerns a been raised by the FDA over a lack of clinical trials to determine if the once-weekly version of the diabetes treatment medication Bydureon has the potential of increasing the risk of developing thyroid cancer.

Who Should Avoid Taking Byetta?

Like all prescription medications, Byetta has certain contraindications, where certain patients can suffer serious life-threatening problems if they take Byetta, exenatide or other brand-names of the type II diabetes medication. Patients should have a discussion with their doctor before taking Byetta if they suffer from any of the following:

  • A prior severe hypersensitivity reaction to Byetta or any exenatide medication
  • Pancreatitis
  • Severe diarrhea
  • Severe renal impairment
  • Kidney transplant
  • Extreme loss of body water
  • Mild to moderate kidney impairment
  • Gallstones
  • Stomach muscle paralysis
  • Lower blood sugar
  • Severe vomiting
  • High blood pressure
  • Pancreas-related adenocarcinoma cancer
  • Habitual alcohol consumption

Byetta, exenatide, and other exenatide-compounded medications are not indicated for weight reduction.

Byetta Side Effects

Many patients have suffered serious side effects after taking the injectable diabetic medication that assists the pancreas in controlling blood sugar levels. The most common mild Byetta side effects include:

  • Nausea and vomiting
  • Diarrhea or constipation
  • Upset stomach
  • Heartburn
  • Loss of appetite
  • Weight loss
  • Headache
  • Dizziness

However, there are more severe Byetta side effects that can cause serious problems to the patient’s health. These include:

  • Hyperglycemia (high blood sugar
  • Increase urination
  • Drowsiness
  • Confusion
  • Rapid breeding
  • Flushing sensation
  • Increased thirst
  • Fruity breath odor
  • Severe back/abdominal/stomach pain
  • Persistent nausea or vomiting
  • Kidney issues including an unexpected change in urination volume
  • Allergic reaction involving swelling/itching of the throat, tongue or face and/or difficulty in breathing, severe dizziness, and rash

Byetta and the FDA

In the first three years after Byetta was first brought to the medical marketplace in 2005, doctors wrote more than seven million prescriptions. However, during that time researchers follow Link between taking Byetta and the increased potential risk of developing acute pancreatitis, a potentially deadly inflammation of the body’s pancreas. Some patients suffer severe abdominal pain and other symptoms including vomiting and nausea.

  • 2009 – The Food and Drug Administration made warning changes on the Byetta Black box labeling to include a precaution and morning over pancreatitis, renal impairment, and macrovascular outcomes. The FDA warned of important limitations when using he drug for any individual that has a history of pancreatitis. The federal agency also stated that:
    • “Byetta is not a substitute for insulin [… and] should not be used in patients with type I diabetes or for the treatment of diabetic ketoacidosis.
    • The concurrent use of Byetta with insulin has not been studied and cannot be recommended.
    • Byetta has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies [for] patients with a history of pancreatitis.”

The FDA also issued a direct warning to individual suffering from pancreatitis stating that postmarking report, including fatal and non-fatal hemorrhagic and necrotizing pancreatitis. Discontinue Byetta promptly. Byetta should not be restarted. Consider other antidiabetic therapies in patients with a history of pancreatitis. The federal agency also noted an increased risk of hypoglycemia when the diabetic medication is used in combination with a sulfonylurea. The FDA also stated that individuals suffering from severe renal impairment, end-stage renal disease, severe gastrointestinal disease, hypersensitivity reactions to angioedema and anaphylaxis should avoid using Byetta.

Byetta Lawsuits

A class action suit has been filed against the manufacturers of Byetta, exenatide and other exenatide-formulated medications. Just a few of those cases involve:

  • Byetta Thyroid Cancer Lawsuits Likely to Be Consolidated into a Multidistrict Litigation Case
  • February 2014 – A federal judge is considering consolidating numerous Byetta lawsuits into a single multidistrict litigation case against Eli Lilly & Co. and Amylin Pharmaceuticals Inc. over damages caused by their diabetic medication. One case involves a plaintiff suing the drug makers after she developed thyroid cancer. The other 35 lawsuits involve some type of injury where the patients developed cancer of the thyroid or pancreas.The San Diego federal judge is considering a motion to consolidate because many of the allegations are similar in nature involving violations of state law, product liability, negligence, negligent representation, breach of warranty, and fraud.
  • Amylin Pharmaceuticals, Eli Lilly Being Sued by a Byetta Pancreatic Cancer Victim
  • August 2013 – An Alabama woman has sued the makers of Byetta making claims that both companies marketed a “defective and unreasonably dangerous” drug. The lawsuit was her response three years after she was initially diagnosed with pancreatic cancer in 2010. Lawsuit documents reveal that current information on Byetta indicate the users are ten times more likely to develop pancreatic issues compared to other humans not using the drug.The Alabama plaintiff’s attorneys have built the case on the fact that the drug maker’s “current warning for the drug are simply inadequate.” The lawsuit is based on the pharmaceutical companies’ failure “in their duties to warn or protect the consuming public.”

    The plaintiff lawyers have made claims that she “suffers from severe and personal injuries, which are permanent and lasting in nature, including the prospect of death, physical pain, and mental anguish, including diminished enjoyment of life, as well as the need for medical treatment, monitoring and/or medications.” Her attorneys have stated that her condition is “tragically, statistically certain to result in her death.”

  • Byetta Injury Lawsuit Alleges Thyroid Cancer Likely Result of Taking the Drug
  • August 2014 – A plaintiff filing a Byetta injury lawsuit was first prescribed the diabetic medication in June 2011 which he used in accordance with directions and her doctor’s instructions. Lawsuit documents reveal that it was less than a year later that the plaintiff was diagnosed with thyroid cancer. She continues to suffer physical, emotional and economic injuries. When the plaintiff realized that there was a correlation between taking Byetta and developing thyroid cancer, she filed a lawsuit against Eli Lilly & Co. and Amylin Pharmaceuticals over their defective medication.The plaintiff is also claiming that the manufacturers were aware or should have been aware, of the potential risks when taking the drug of developing serious side effects including thyroid cancer. Her attorneys are saying that the drug manufacturers instead chose to conceal their knowledge of the dangers of the medication from her, her doctors and the medical community. The woman stated that had she been made aware of how bad the medication was, she would not have taken the drug and instead chose other alternative ways of treating her condition.

    The California plaintiff is not a part of the ongoing Byetta class action lawsuit. Her attorneys have taken independent legal action against Amylin Pharmaceuticals and Eli Lilly & Co. by filing the case on their failure to warn, negligence, negligent misrepresentation, design defect, breach of express and implied warranties, punitive damage, and fraudulent concealment.

  • Another Byetta Wrongful Death Lawsuit Filed by an Alabama ManOctober 2013 – Both Amylin Pharmaceuticals and Eli Lilly and Company are facing another Byetta wrongful death lawsuit, this time filed by an Alabama widower whose wife died from pancreatic cancer after taking Type II diabetes medications. Lawsuit documents reveal that the patient was diagnosed with pancreatic cancer after she had been prescribed Byetta and Januvia to treat her diabetic condition. The deceased woman’s husband stated that his wife was first prescribed the Type II diabetes medication in 2007 and took the drugs until 2010. It was then that doctors detected she had pancreatic cancer. The patient succumbed to her condition in 2011.Attorneys working on behalf of the Alabama client has charged the drug makers with a breach of warranty, strict liability, negligence, concealment, fraudulent misrepresentation, and loss of consortium. The plaintiff is asking that he be provided compensatory and punitive damages by both drug makers to provide financial recovery for his extensive medical bills and funeral expenses associated with his wife’s death.

    This is not the first Januvia/Byetta lawsuit filed in the United States against the pharmaceutical companies that make, promote, market, and sell their diabetic medications. Dozens of lawsuits have been consolidated into multidistrict litigation (MDL) after being filed in the US District Court for the middle District of Alabama. While the likely outcome of these cases is not predictably certain, the FDA has released research showing the correlation between taking these drugs and precancerous cellular changes.

Providing Legal Representation Byetta Lawsuit Cases

The Byetta injury case lawyers at the Drug Law Center are currently reviewing pancreatitis cases for users taking the diabetic treatment medication. Our attorneys are investigating cases where patients have suffered pancreatitis because the pharmaceutical company failed to adequately warn them about the potentially serious side effects before taking the medication.

If you have suffered injury or lost a family member or friend who was injured by pancreatitis or pancreatic cancer, our team of dedicated attorneys can help. We are currently investigating, reviewing, and accepting Byetta injury cases to provide legal representation. This will ensure our clients will receive the highest amount of financial compensation available. To minimize the financial burden for our clients during the litigation process, our law firm is currently postponing any payment of our legal fees until after we have successfully resolved the case at a jury trial or negotiate a settlement on their behalf.

Contact us today to schedule a complimentary case evaluation free of charge. By speaking with attorneys, our firm can determine the merits of your case and provide numerous legal options on the best way to ensure your financially compensated for your injuries.

Sources:

https://my.clevelandclinic.org/health/articles/non-insulin-injectable-medications

http://www.mayoclinic.org/diseases-conditions/type-2-diabetes/expert-answers/byetta/faq-20057955

http://www.mayoclinic.org/drugs-supplements/exenatide-subcutaneous-route/proper-use/drg-20068401

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021773_ByettaTOC.cfm

 

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