Byetta® Pancreatitis
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Pancreatitis is a serious disease in which the pancreas (a digestive gland that makes insulin) becomes inflamed. Damage occurs when pancreatic enzyme that digest food (especially trypsin) are activated in the pancreas instead of the small intestine.
The pancreatitis may be "acute," meaning that it appears suddenly and becomes severe very quickly, or "chronic," meaning that it appears gradually and persists over a period of months or even years.
Pancreatitis Causes
Most cases of pancreatitis are due to heavy, long-term use of alcohol, or to gallstones. However, it is believed that treatment for type 2 diabetes with the injection-pen Byetta® may result in pancreatitis.
Various causes have been identified for acute pancreatitis and chronic pancreatitis, including:
- Alcoholism
- Gallstones
- Abdominal surgery
- Certain medications
- Cigarette smoking
- Cystic fibrosis
- Endoscopic retrograde cholangiopancreatography (ERCP), when used to treat gallstones
- Family history of pancreatitis
- High calcium levels in the blood (hypercalcemia)
- High levels of parathyroid hormone in the blood (hyperparathyroidism)
- High triglyceride levels in the blood (hypertriglyceridemia)
- Infection
- Injury to the abdomen
- Pancreatic cancer
Pancreatitis Symptoms
The most common symptoms of pancreatitis are:
- Nausea
- Vomiting that is worsened with eating
- Mild to severe abdominal pain that radiates to the back.
- Higher heart and respiratory rates
- Fever or jaundice
- Unexplained weight loss
- Pain after eating or when lying down
If you have been taking Byetta® and you're experiencing any of these symptoms, contact your physician immediately.
Acute Pancreatitis
Acute pancreatitis is a painful, dangerous side effect that has been observed in some patients treated with Byetta®. The inflammation of the pancreas signals that the cells of the pancreas are attacking the pancreas itself.
Cases of acute pancreatitis can lead to dangerous and life-threatening complications, including:
- Spreading of the infection
- Organ failure
- Pseudocysts
- Abscess
- Shock
- Respiratory failure
If you have been taking Byetta® and you're experiencing any of these symptoms, contact your physician immediately.
Severe Acute Pancreatitis
A severe attack of acute pancreatitis can easily put a patient into the hospital's intensive care unit. A severe attack can cause significant damage to the pancreas, and it can be the triggering factor for chronic pancreatitis, a very troubling condition that may last for months or years.
A mild attack of acute pancreatitis may improve on its own within a week or so, but an emergency room visit and ensuing hospital stay are necessary in most other pancreatitis cases.
Over time, chronic pancreatitis destroys pancreatic cells and wreaks havoc with the body's production of insulin and digestive enzymes. Chronic pancreatitis can also lead to pancreatic cancer, one of the most deadly forms of cancer.
Chronic Pancreatitis
Chronic pancreatitis is constant inflammation of the pancreas. The disease does not not heal and gets worse over time, and ultimately leads to permanent damage. Chronic pancreatitis changes the gland's proper functions and structure. Patients with this disease usually have persistent abdominal pain or steatorrhea resulting from the malabsorption of fats in food.
Chronic pancreatitis can lead to a number of complications including:
- Fatal bleeding
- Malnutrition
- Addiction to pain medications
- Pancreatic cancer (one of the most deadly forms of cancer)
Hemorrhagic Pancreatitis
Hemorrhagic pancreatitis is the form of pancreatitis in which the pancreas is bleeding. It's a life-threatening condition with a high death rate. The disease can also lead to very serious complications, including:
- Heart failure
- Kidney failure
- Acute respiratory distress syndrome
Hemorrhagic pancreatitis was the cause of death reported for two individuals who were Byetta® users.
In pancreatitis, it is thought that the digestive enzymes that the pancreas normally releases in an inactive form — e.g., lipases, amylases, trypsin — become active inside the pancreas and attack the tissue of the pancreas itself, often causing a hemorrhage when the inflammation damages the blood vessels. The process of enzymes digesting the site of their own production, the pancreas, in this case, is called "autodigestion."
In August 2008, the U.S. Food and Drug Administration (FDA) strengthened the Byetta® warning label to advise patients of the risks after receiving the two hemorrhagic pancreatitis fatality reports and four other hospitalizations related to the drug.
The FDA had already received 30 reports of acute (sudden-onset) pancreatitis among Byetta® users, although none of these individuals had hemorrhagic pancreatitis.
Necrotizing Pancreatitis
Necrotizing pancreatitis is a form of pancreatitis in which the inflammation caused by pancreas-attacking enzymes results in necrosis, or the death of tissue (in this case, pancreas tissue).
Necrotizing pancreatitis is dangerous side effect that has been observed in some patients treated with Byetta®.
Someone who has necrotizing pancreatitis is critically ill. Diabetics who are using Byetta®, a twice-daily injection of Exenatide, may be at a greater risk of developing necrotizing pancreatitis.
Acute Necrotizing Pancreatitis (ANP)
Acute necrotizing pancreatitis (ANP) is the most severe form of pancreatitis, and it's been estimated that ANP occurs in about 20 percent of all episodes of pancreatitis. In addition to being life-threatening on its own, necrotizing pancreatitis is often accompanied by severe and possibly fatal complications such as:
- Shock
- Hemorrhaging — uncontrolled bleeding
- ARDS — acute respiratory distress syndrome
- SIRS — systemic inflammatory response syndrome, an inflammatory state of the entire body
- Hypocalcemia — an abnormally low level of calcium in the blood
- Multi-organ failure — e.g., kidney, heart failure
- Pancreatic abscess — an infection characterized by pus in or near the pancreas
Byetta® and pancreatitis are suspected to be linked, based on cases of acute pancreatitis in Byetta® users reported to the FDA.
Although the link is still being investigated by the FDA and by the manufacturers, Amlyn and Eli Lilly Co., the FDA issued a second, stronger warning about the Byetta® and pancreatitis connection in August 2008.
The second FDA warning referred to six reports of hemorrhagic pancreatitis or necrotizing pancreatitis in patients treated with Byetta®. Several deaths of Byetta® users due to pancreatitis have also been documented.
Speak With A Byetta® Lawyer
If you or a loved one suffered serious injuries related to Byetta®, you may have grounds to file a lawsuit in which you can seek compensation for damages such as medical bills, permanent disabilities, pain and suffering and other damages. Contact us to speak with a Byetta® lawyer.
