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FDA Okays Diabetes Drug for First-Line Use, Adds Warning
Posted by: admin in Pharmacy Drugs on November 07th, 2009
WASHINGTON — The FDA has expanded the indication and prescribing language for the type 2 diabetes drug exenatide (Byetta), extending its approval to use as monotherapy for glycemic control in adults.
The updated warning label includes a pancreatitis caution, including nonfatal hemorrhagic or necrotizing pancreatitis, and an expansion of an existing warning for patients with renal impairment.
The new indication was based on a clinical study of 232 patients unable to achieve glycemic control through diet and exercise alone.
Those enrolled reduced blood sugar over three months by 0.7% and 0.9%. with the 5 mcg and 10 mcg dosages respectively versus placebo. Patients lost an average of around 6 pounds between exenatide groups.
Although the updated label warns of pancreatitis, a recent study found the disease was not more common in exenatide than in other type 2 diabetes drugs. (See EASD: No Extra Risk of Acute Pancreatitis Seen with Exenatide)
Additional side effects include severe allergic reactions, nausea, vomiting, diarrhea, dizziness, headache, jitters, and acidic stomach.
The injectable drug was the first GLP-1 receptor agonist for improved blood sugar after food intake for patients with type 2 diabetes. Exenatide was first marketed in 2005 by drug manufacturers Amylin Pharmaceuticals and Lilly.
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