Byetta Linked To Painful Inflammation Of Pancreas In 30 Reported Cases
The Byetta drug, also known as exenatide, is a medication intended to help control blood glucose levels in type 2 diabetics. Part of a class of medications known as “incretin mimetics,” it works by aiding the pancreas in producing insulin more efficiently. However, it has also been linked to the painful inflammation of that same organ.
The type of pancreatitis typically associated with the Byetta drug is acute, which comes on suddenly. The hallmark symptom is severe upper abdominal pain that radiates through the back, often coupled with nausea and vomiting. It may or may not also include internal bleeding, high or low blood pressure, elevated heart and respiratory rates, or abdominal tenderness. Though a doctor can run several different laboratory tests, it is often diagnosed using a CT scan.
The Byetta drug is a synthetic version of a hormone found in the saliva of the Gila monster, a type of venomous lizard that lives in the southwestern United States and northern Mexico. Its effectiveness is attributed to the fact that the lizard’s hormone is very similar to glucagon-like peptide-1 (GLP-1), a hormone that is found in the human digestive track that can increase insulin production when blood sugar levels are too high. Because the lizard version remains effective for much longer than the one in our own bodies, this synthetic formulation has proven useful for diabetics. Due to this history, it is therefore sometimes referred to as “lizard spit.”
There are several different ways that the medicine works in the body:
Augmenting pancreas response after meals
Suppressing pancreatic release of glucagon while eating
Slowing down gastric emptying
Reducing appetite by promoting satiety via hypothalamic receptors
Reducing liver fat content
The Food and Drug Administration (FDA) approved the medicine on April 28, 2005 for use in patients who were not benefiting from the more common oral medicines. The new type is injectable, provided subcutaneously twice a day, typically in the stomach, upper arm, or upper thigh.
Less than two years later, the FDA began requiring manufacturers to provide additional warnings and labeling. The requirement was enacted because of information linking more than 30 confirmed cases of the painful organ ailment to use of the medicine. Since this requirement went into effect, more people have died, and the FDA may be evaluating additional alterations to warning labels that accompany patient information.
Additionally, complications sometimes occur in conjunction with the disorder, including these possible Byetta side effects:
Hypocalcemia (low calcium)
High blood glucose
Systemic inflammatory response syndrome (SIRS)
Infection of the organ bed
The manufacturers are also in the process of developing a longer-acting version of the drug. Given concerns over the potential problems associated with the current formula, the FDA will likely require a longer-term study of any newly developed drug. If the medication does cause damage to the pancreas, a formulation with a longer half-life will simply remain in the body longer and potentially cause even more injury.
Byetta Lawsuits Attorneys