Byetta Warnings

Byetta is a brand-name prescription drug co-developed and co-marketed by Amylin Pharmaceuticals and Eli Lilly. The generic substance in Byetta is called exenetide. The U.S. Food and Drug Administration, FDA, approved Byetta in 2005. Byetta is indicated as an adjunct to diet and exercise to improve control of blood sugar levels in adults with type 2 diabetes mellitus, according to the product label. Byetta increases secretion of insulin from the pancreas and reduces spikes in blood sugar after meals. Byetta has several warnings.

Acute Pancreatitis

Byetta must be discontinued promptly and not restarted in patients who develop acute pancreatitis, a sudden inflammation of the pancreas. The FDA announced that it received post-marketing reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta. Hemorrhagic pancreatitis involves bleeding within the pancreas, and necrotizing pancreatitis involves dying of cells within the pancreas. All of these patients required hospitalization and two died. Symptoms of acute pancreatitis include severe abdominal pain, back pain and vomiting.

Hypoglycemia

Hypoglycemia, or low blood sugar, can occur if Byetta is used in combination with a sulfonylurea, a class of drugs that help to manage blood glucose levels in people with diabetes. Low blood sugar can be extremely dangerous and fatal. Symptoms associated with low blood sugar include hunger, dizziness, sweating, nervousness, confusion and anxiety. Adjusting the dosages of both medications may reduce the risk of hypoglycemia.

Kidney Impairment

Byetta can cause severe kidney disease, including kidney failure. The FDA received 78 reports of kidney problems from patients taking Byetta between April 2005 and October, 2008, prompting the government agency to mandate a warning on the Byetta product label restricting use of the drug in patients with kidney impairment or end stage renal disease, and used with caution in patients with a kidney transplant. Byetta can cause nausea and vomiting, and exacerbate poor kidney function. Kidney problems could affect the ability to urinate, and lead to changes in frequency of urination and color of urine, plus swelling of the hands and feet. A buildup of waste products that the kidneys are unable to filter can enter the blood and lead to serious or life-threatening illnesses.

Severe Gastrointestinal Disease

Since Byetta can cause nausea and vomiting, it is not recommended for patients with severe gastrointestinal disease. Byetta can also cause gastroparesis, a condition that delays or slows down the stomach from emptying its contents. As a result, some people could feel bloated. Research published in Endocrine Practice demonstrated a 36% discontinuation rate among patients taking Byetta because of adverse gastrointestinal effects.

Immunogenicity and Hypersensitivity

Some people can develop antibodies to Byetta that could impair the drug's ability to reduce blood sugar levels. According to the product label, post-marketing reports have indicated that some people can experience hypersensitivity reactions to Byetta. These reactions include anaphylaxis and angioedema. Anaphylaxis is a condition characterized by sudden inability to breathe, loss of consciousness and sometimes death. Angioedema is characterized by swelling underneath the skin. If these conditions occur, Byetta therapy should immediately stop.