Byetta

  • Byetta Medical Record Review & Outsourcing Services

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. All the 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.

Bristol-Myers Squibb, one of the world's largest pharmaceutical companies, bought Byetta for an estimated $5.3 billion in 2012.

The drug was approved by the U.S. Food and Drug Administration (FDA) on April 28th, 2005. On 2nd November 2009, it was approved for the expanded use as a First-line treatment for Type 2 Diabetes. On 20th October 2011, it was approved for use with Insulin Glargine in the U.S.

In January 2012, Bydureon, a once-weekly injection was finally approved by the FDA, which was rejected twice earlier in 2010 because of heart rhythm abnormalities. (Bydureon is a  longer-lasting version of Byetta.)

Serious Alleged Injuries may include:

  • Pancreatic Cancer
  • Kidney failure
  • Severe allergic reaction
  • Pancreatitis
  • Pre-cancerous cellular changes called pancreatic duct metaplasia
  • Hemorrhagic Pancreatitis
  • Necrotizing Pancreatitis
  • Thyroid Cancer

FDA SAFETY WARNINGS:

  • In October 2007, the FDA asked the Amylin Pharmaceuticals, Inc. to include a warning about pancreatitis in precautions section of the product label.
  • In August 2008, the FDA issued a prominent warning against Hemorrhagic and Necrotizing Pancreatitis.
  • On November 02, 2009, FDA approved revisions in drug label to include information of altered kidney function, acute renal failure, and insufficiency.
  • In March 2013, the FDA issued a Safety communication that indicated further reports will be investigated for possible increased risks of pancreatitis and pre-cancerous findings.
  • In May 2013, the FDA issued safety communications linking the Byetta and other incretin mimetics to serious complications, such as pancreatic diseases.

Lawsuit Allegations:

In 2013, Byetta cases along with several diabetes medications (Victoza, Januvia, and Janumet) were centralized in a multidistrict litigation MDL 2452 (In Re: Incretin Mimetics Products Liability Litigation presided by Judge, Anthony J. Battaglia) in the Southern District of California. Lawsuits filed alleged that though the manufacturers knew about the link of their product to cancer side effects in several studies, the details were not made public. Byetta lawsuits were filed across the nation, claiming that the drug caused the patients to develop thyroid and pancreatic cancer.

In November 2015, Judge Battaglia granted a summary judgment in favor of the defendants, following a preemption protocol dismissing all the cases in the MDL.

In September 2016, plaintiff’s attorneys filed an appeal to the Ninth Circuit U.S. Court of Appeals on behalf of the MDL stating that Judge Battaglia misinterpreted the U.S. Supreme Court preemption law.

Evidences:

  • Duration of Byetta usage
  • Usage of Byetta in Pharmacy Records
  • 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.

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