Parker, Waichman, Alonso LLP

Home » Topics » Defective Drugs » Byetta

Byetta Side Effects Linked to Acute Pancreatitis

In October 2007, Byetta, a drug used to treat diabetes, received new warnings that it could cause acute pancreatitis, a sometimes fatal inflammation of the pancreas.  The new warnings were added after the Food & Drug Administration (FDA) received reports that 30 patients taking Byetta had developed the disorder.  The makers of Byetta, Amylin Pharmaceuticals and its partner Eli Lilly & Co., also agreed to include a precaution on the label after the drugs side effects caused complications, including kidney failure.

Byetta Diabetes Drug Injection
Byetta, approved by the FDA in 2005, is an injection taken before morning and evening meals.   It was approved for use in people with type 2 diabetes who weren’t able to manage their blood-sugar or blood-glucose levels well enough with other drugs.  Byetta is a synthetic form of a hormone taken from a lizard that helps to boost the production of insulin in order to control blood sugar.

Pancreatitis a Possible Side Effect of Byetta
Pancreatitis is an inflammation of the pancreas that can cause bleeding, tissue damage and infection.  Severe cases of pancreatitis can lead to the release of toxins and enzymes into the blood stream that can injure the heart, lungs, kidneys or other organs.  In some instances, acute pancreatitis can be fatal.  According to the FDA, of the 30 patients who suffered from pancreatitis while taking Byetta, five later developed other complications like kidney failure.   And the FDA reported that 22 of those with pancreatitis improved after they stopped taking Byetta.

New Byetta Side Effects Labeling
The new information on Byetta’s label warns that pancreatitis is a possible side-effect of the drug.   The FDA advised physicians and patients to be alert to warning signs for the disorder, including persistent and severe abdominal pain that can radiate to the back.  The pain can be accompanied by nausea and vomiting.  Nausea, vomiting, diarrhea, indigestion and some abdominal discomfort are common side effects of Byetta, but the FDA said that the symptoms of pancreatitis would be much more severe and persistent.  The FDA said that patients who develop pancreatitis should stop taking Byetta immediately.

The previous Byetta label did make mention of pancreatitis as a possible side effect in the “Adverse Reactions” section.  However, pancreatitis is only mentioned once within that 18-page document, and it is very likely that an individual skimming through the old Byetta label would miss it entirely. What’s worse, pancreatitis was listed last among many other possible adverse reactions, including constipation and flatulence.  There was no way a patient taking Byetta would have known how serious a disorder pancreatitis is, nor would they have known its signs and symptoms by reading the old Byetta label.

Byetta & Pancreatitis Lawsuit Lawyers
If you or a loved one has been injured by Byetta, you may have valuable legal rights.  Our experienced Byetta and Pancreatitis lawsuit lawyers can review your case today please fill out the form to the right for a free case review by a qualified attorney.