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Byetta (Exenatide) is an injectable subcutaneous anti-diabetic drug belonging to the class incretin mimetics, manufactured by San Diego-based Amylin Pharmaceuticals/Eli Lilly & Co. and distributed by AstraZeneca Pharmaceuticals LP. Byetta is similar to Januvia, Janumet and Victoza and all these four drugs are classified as Incretin Mimetics and used to treat Type 2 Diabetes Mellitus. It is a glucagon like peptide-1 (GLP-1) receptor agonist used as an adjunct to diet and exercise program, to improve the glycemic control in adult patients with Type 2 diabetes mellitus.
The drug was approved by U.S. Food and Drug Administration (FDA) on April 28th, 2005. On 2nd November 2009, it was approved for the expanded use as First line treatment for Type 2 Diabetes. On 20th October 2011, it was approved for use with Insulin Glargine in U.S. In January 2012, Bydureon, weekly once injection was finally approved by FDA, which was rejected twice earlier in 2010 because of heart rhythm abnormalities.
- Kidney failure
- Severe allergic reaction
- Pre-cancerous cellular changes called pancreatic duct metaplasia
- Hemorrhagic Pancreatitis
- Necrotizing Pancreatitis
- Thyroid Cancer
In October 2007, FDA asked the Amylin Pharmaceuticals, Inc to include the warning about pancreatitis in precautions section of product label. In August 2008, FDA issued prominent warning against Hemorrhagic and Necrotizing pancreatitis. In November 02, 2009, FDA approved revisions in drug label to include information of altered kidney function, acute renal failure and insufficiency. In March 2013, FDA issued a Safety communication that indicated further reports will be investigated for possible increased risks of pancreatitis and precancerous findings.
Personal injury cases were filed against markers and marketers of Januvia (Merck & Co. and its affiliates) and Byetta. All federal cases on all four drugs Byetta, Januvia, Janumet and Victoza were centralized in August 2013 in the Southern District of California as Incretin Mimetics Products Liability Litigation (MDL No. 2452).
Lawsuits claim that the drug makers have marketed these Incretin Mimetics, without making the public aware about the risk of pancreatic cancer and pancreatitis.
Evidence to be looked for in potential cases
- Usage of Byetta in Pharmacy Records
- Duration of Byetta usage
- Indications for usage of Byetta in Medical Records
- Complications and their Treatment after Byetta Intake
Medical Record Review and claim validation of Byetta case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.