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Byetta Approved for Stand-Alone Use

Recently, the FDA released a statement on Byetta (Amylin/Lilly’s exenatide) that updated several warnings for the drug as well as expanded its usage. The warnings section includes an update on the risk of pancreatitis (inflammation of the pancreas) and the risk of using Byetta in patients with renal (kidney) impairment. If you are on Byetta and concerned you may be at risk, we urge you to discuss the warning label with your physician. However, we emphasize that these risks have not been clearly associated with Byetta – people with diabetes are inherently at higher risk for pancreatitis and kidney disease, clouding allegations. In addition to updating the warnings section, the FDA also expanded the usage of Byetta. Since its approval, Byetta could only be administered in combination with metformin, a sulfonylurea (e.g., glimepiride, glipizide), a thiazolidinedione (e.g., Avandia, Actos), or a certain combination of these drugs. However, the update allows it to be administered on its own as a stand-alone therapy, not in combination with other drugs. Although this may not significantly change how Byetta is prescribed (metformin still stands strong as the first-line drug of choice for patients with type 2 diabetes, and with good reason) we believe this represents a big step for GLP-1 analogs, the class of drugs to which Byetta belongs. Given the their unique ability to control glucose levels specifically after meals and induce weight loss with a low risk of hypoglycemia, the drugs are certainly gaining in popularity, particularly amongst some leading physicians: A panel of expert endocrinologists (including diaTribe advisory board members Drs. Zach Bloomgarden and Paul Jellinger) convened by the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE) recently promoted the use of Byetta over sulfonylureas as a secondary therapy to metformin. We hope to see even more efficacious and safe GLP-1 analogs in the near future.

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