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The BYETTA Drug Lawsuit

BYETTA is an injectable prescription medication used to control blood sugar in patients who suffer from type II diabetes. BYETTA is a short-acting form of exenatide. Marketed, developed, and commercialized by Amylin since 2013, BYETTA has been a successful type II diabetes treatment for many patients.

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What is BYETTA?

BYETTA is an injectable prescription medicine used to improve blood sugar (glucose) levels in adults with type 2 diabetes. According to the manufacturer, BYETTA was the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the FDA for the treatment of type 2 diabetes. BYETTA works in conjunction with the stomach, liver, pancreas, and brain to improve blood sugar levels, similar to the human incretin hormone GLP-1. BYETTA can be used with metformin, a sulfonylurea, a thiazolidinedione or Lantus® (insulin glargine).It was approved for use in the United States in 2005 and has been used by almost 2 million diabetic patients since its introduction. For best results BYETTA should be used in conjunction with lifestyle changes such as improved diet and increased exercise, but it should not be used as a substitute for insulin.

What is BYETTA used for?

Controlling blood sugar is extremely important for diabetics who can experience a variety of serious health issues if their blood sugar is imbalanced, including kidney damage, nerve damage, sexual dysfunction, blindness, and loss of limb. Diabetes can also increase a person’s risk of stroke and heart attack.

  • Although BYETTA is used to control blood sugar levels in type II diabetes patients, it may also successfully help some patients lose weight. Amylin does not encourage the “off-label” use, but they have conducted studies which have shown that BYETTA has been effective at promoting weight loss.

BYETTA Usage and Statistics

Millions of Americans have been diagnosed with diabetes. In fact, the American Diabetes Association estimates there are close to 30 million Americans with diabetes. Many of those diagnosed and undiagnosed are not currently receiving adequate treatment of their condition. Diabetes is currently the seventh leading cause or contributing factor to death.

How BYETTA Works

BYETTA injections improve a user’s ability to control the release of insulin in the body. For example, when a person eats their blood sugar level increases but taking BYETTA can help the pancreas release the appropriate level of insulin and improve blood sugar levels by mimicking the actions of a hormone called glucagon-like peptide-1, or GLP-1.

Side Effects of BYETTA

  • Side-effects of taking BYETTA can be minor or severe. They are more common when you first start taking the medication or when you increase your dosage. Talk to your doctor if you have concerns, especially if you experience any symptoms related to pancreatitis such as persistent severe abdominal pain, radiating to the back, with or without vomiting. If pancreatitis is suspected BYETTA use should be immediately terminated. Some side-effects can be severe and require immediate medical care.
  • Nausea
  • Vomiting
  • Diarrhea
  • Feeling jittery
  • Dizziness
  • Headache
  • Stomach acid
  • Constipation
  • Weakness
  • Swelling
  • Weight gain
  • Shortness of breath
  • Difficulty urinating
  • Low blood sugar
  • Loss of appetite
  • Impaired kidney dysfunction
  • Increased risk of thyroid cancer
  • Acute pancreatitis
  • Fatal and non-fatal hemorrhagic or necrotizing pancreatitis
  • Hypoglycemia especially when used in combination with a sulfonylurea (SU)

BYETTA Medical Studies

Three 30-week, double-blind, placebo-controlled trials were conducted to evaluate the safety and efficacy of BYETTA and its ability to control blood glucose. In the trials, scientists evaluated the results of 1,446 patients. Patient’s blood sugar was evaluated while taking metformin alone, a sulfonylurea alone, or a combination with BYETTA or a placebo. Results indicated that patients in each study who took BYETTA did have reductions in the mean change of their levels of HbA1c and reduced blood glucose. BYETTA was also shown not only to help control blood sugar levels for the participants but also to help them lose weight. In another study 194 overweight or obese patients with Type 2 diabetes were given BYETTA and lost six pounds over 24 weeks.

BYETTA Black Box Warnings

  • Patients using BYETTA should understand the increased potential risk for worsening renal function and hypersensitivity reactions. If patients suffer from any signs or symptoms of possible reactions they should stop taking BYETTA immediately and seek medical attention. Patients should also notify their doctors if they are pregnant or intend to become pregnant. It is not known whether BYETTA or other anti-diabetes medications increase a patient’s risk of a heart attack or stroke. BYETTA may also cause loss of kidney functions or severe allergic reactions. BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. BYETTA is not recommended for patients with severe gastrointestinal disease (eg, gastroparesis). Patients should not take BYETTA if they have a severe allergic reaction including problems breathing, fainting, dizziness, difficulty swallowing, a swollen face, tongue or throat, rapid heartbeat, or if they have had pancreatitis stones in their gallbladder (gallstones), a history of alcoholism, or a history of high blood triglyceride levels.

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