UPDATE: A new version of Byetta is under development by Eli Lilly and Amylin. This drug, called Byetta LAR, is long acting and is intended to by used only once a week. The makers report that this drug does not carry unacceptable cardiovascular risks and they claim they have not received any reports of pancreas-related side effects on this medication. Of course, it is far too soon to know for sure the possible side effect risks associated with this new Byetta medication. Byetta’s makers plan to submit a request for Byetta LAR approval some time in mid-2009.
Byetta, an injectable medication approved to treat adults with Type II Diabetes, has been linked with numerous cases of serious injury, including serious drug side effects affecting the pancreas. In fact, the Food and Drug Administration (FDA) has received over 30 reports of pancreatitis, including at least 4 fatal cases, since 2007.
Please read on to learn more about this drug, how it works, the serious side effects to which it has been linked, and what to do if you have suffered a Byetta related injury. Contact us to learn more about your legal rights following a serious Byetta injury or if you questions regarding a Byetta lawsuit.
What is Byetta?
Byetta, an injection of the synthetic hormone extenatide, is a medication approved in 2005 to improve glucose (blood sugar) control in adults with Type II diabetes. Byetta’s active ingredient simulates the pancreatic cells to produce insulin when blood sugar is high.
This drug can be used in conjunction with other diabetes medications, such as metformin, a sulfonylurea, or a thiazolidinedione. However, Byetta is not a substitute for insulin in people with diabetes requiring insulin treatment.
According to the makers of Byetta – San Diego-based Amylin Pharmaceuticals and Eli Lilly and Co. based in Indianapolis – this drug works in four different ways:
- It prompts the pancreas to make the right amount of insulin following a meal
- It prevents the liver from producing too much glucose (sugar) when the body does not need it.
- It might reduce a patient’s appetite
- It slows down the movement of food and glucose from the stomach
Who Should Not Use Byetta?
The following patients are cautioned not to take Byetta because the risks have been deemed greater than the drug’s benefits:
- People with digestion or stomach problems
- People with serious kidney disease
- People who are pregnant or breastfeeding
- People with a history of pancreas problems
What Are the Common Side Effects of Byetta?
In addition to the pancreas-related side effects described below, other common side effects have been linked to Byetta use. These Byetta side effects include:
- Hypoglycemia (low blood sugar) in patients who also use a medication containing sulfonylurea
- Nausea
- Vomiting
- Diarrhea
- Dizziness
- Headache
- Jitters
- Increased stomach acid
- Stomach pain
The presence of these Byetta side effects might indicate a serious injury. Patients that develop any of these symptoms are encouraged to contact their health care professional to determine if their symptoms indicate a serious Byetta side effect.
What Are the Serious Byetta Side Effect Risks?
According to the FDA, Byetta has caused serious side effects in nearly 40 patients. In 2007, federal regulators reported receiving 30 reports of life-threatening pancreas problems in patients taking Byetta. Of these 30 patients who had been seriously injured by Byetta, 21 required hospitalization for acute pancreatitis, though none of them died.
Furthermore, 27 of these 30 patients reportedly had other risk factors for pancreatitis, such as gallstones, alcohol consumption, and hypertriglyceridemia.
In some of these cases, the symptoms of pancreatitis seemed to improve when Byetta use was stopped, but the symptoms of pancreatitis returned in patients who began to use the drug later on. Thus, doctors were encouraged by the FDA to take patients off Byetta if they developed symptoms of pancreatitis. Subsequent treatment with Byetta was not recommended unless the doctor found another cause for a patient’s pancreatitis.
In fall 2008, the FDA made another announcement about Byetta side effects. This time, the agency received two reports of fatal pancreatitis and four additional cases Byetta-related pancreatitis requiring hospitalization. As a result of these new cases, the FDA strengthened the warnings about life-threatening Byetta side effects.
These new Byetta side effect cases involved the development of hemorrhagic pancreatitis (characterized by pancreas inflammation and bleeding) and necrotizing pancreatitis (a condition in which the pancreas destroys itself).
What is Pancreatitis?
The pancreas is a gland located behind the stomach that is responsible for secreting digestive enzymes into the small intestine to help in digesting fats, proteins, and carbohydrates and for releasing insulin and glucagons (two hormones) into the bloodstream. These hormones regulate how the body stores and utilizes food for energy.
Pancreatitis is a potentially serious inflammatory disease that can damage the pancreas when enzymes activated at the wrong time begin to attack the pancreas. In serious cases, pancreatitis can cause:
- Bleeding
- Serious tissue damage
- The formation of cysts
- Infection
- Damage to other organs, such as the heart, kidneys, and lungs
Questions about a Byetta Lawsuit?
Patients who are taking Byetta should be aware of the possible symptoms of a serious pancreas related side effect. Signs of pancreatitis can include:
- Pain in the upper abdominal area, which often extends into the back. This pain can be intensified by eating, particularly with the consumption of high-fat foods.
- Tenderness or swelling of the abdomen
- Nausea
- Vomiting
- Fever
- Increased heart rate
- Jaundice (yellowing of the skin and teeth)
- Trouble breathing
If you or a loved one has developed pancreatitis or any other Byetta side effect, you may be able to seek compensation for your medical expenses, pain and suffering and more. Please contact our qualified Byetta attorneys for a free and confidential evaluation of your case.