After Linked to Pancreatitis, The FDA Required Warning Label On Byetta Injection
In 2007, over 1.6 million U.S. adults were diagnosed with new case of diabetes. To help control this problem, many drug companies have been creating new medications designed to help patients control their blood sugar through modified insulin secretion, and other methods. Unfortunately, because of life-threatening complications, in that same year the Food and Drug Administration (FDA) began requiring two companies to include more prominent and complete warning labels on the Byetta injection medication, as it had been shown to cause painful, even deadly ailments in some users. Byetta injection was introduced to the public on April 28, 2005, for many of the patients that were not benefitting from the popular oral medications on the market at the time. As an injectable exenatide class medicine, the new product is administered with a syringe, subcutaneously, twice daily. It is most effective if given in the stomach area, upper arm skin, or the upper thigh. Amylin Pharmaceuticals and Eli Lilly and Company produce and market the Byetta injection. Recently, they have come under considerable criticism from some for not supplying consumers with complete warning information relating to possible complications. Though not as serious, common adverse reactions to the medicine include the following: However, the most troubling and debilitating complication from the current dosage is the drastically increased risk of pancreatitis. In fact, in 2007, FDA began requiring the manufacturers to provide additional warnings and labeling on packaging. The requirement was enacted because of information linking more than 30 confirmed cases of the painful organ ailment to the medication. 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. Pancreatitis is a painful inflammation of the pancreas. The kind associated with this medication is acute, meaning that it comes on suddenly. Upper abdominal pain, radiating throughout the back, is the most commonly reported ailment, along with nausea and vomiting. Other indications include internal bleeding, extreme changes in blood pressure, elevated heart and breathing rates, and tenderness in the affected area. CT scans are typically used to examine the pancreas, and confirm the existence of inflammation. For patients that do not react poorly to the product, it helps type 2 diabetics control the ailment in several ways: 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 manufacturers are also in the process of developing a longer-acting version. Given concerns over the potential problems associated with the current concentration of Byetta insulin , 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.
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