Byetta Lawsuit
What is Byetta?
The Byetta pen (generic: exenatide) is an injectable incretin mimetic diabetes medication that helps control blood sugar levels in patients with type 2 diabetes. The drug works by helping the pancreas produce insulin more effectively. Byetta is made by AstraZeneca, and was first approved by the U.S. Food & Drug Administration (FDA) in April 2005.
What’s the Problem?
Byetta has been linked to serious side effects including pancreatic cancer, thyroid cancer, acute hemorrhagic pancreatitis and necrotizing pancreatitis.
FDA Warning on Byetta Pancreatitis
In October 2007, the FDA issued a Drug Safety Communication indicating that at least 30 Byetta users had been diagnosed with acute pancreatitis. The warning was updated in August 2008, after at least six additional cases of necrotizing pancreatitis or hemorrhagic pancreatitis were identified among diabetes patients treated with Byetta, including at least two deaths.
Pancreatitis Symptoms
Pancreatitis is an inflammation of the pancreas, which can cause symptoms including:
- Severe upper abdominal pain which may radiate through the back
- Nausea
- Vomiting
- High blood pressure (hypertension)
- Low blood pressure (hypotension)
- Elevated heart or respiratory rates
Byetta Pancreatic Cancer Studies
A study published in the journal Gastroenterology in July 2011 found that the development of pancreatic cancer in Byetta users was three times greater than in diabetes patients treated with other types of drugs.
In February 2013, another study published in JAMA Internal Medicine found that Byetta users were twice as likely to be hospitalized with pancreatitis, which can lead to pancreatic cancer if left untreated.
How Can Byetta Cause Pancreatic Cancer?
It is still unknown for certain whether Byetta or other similar incretin mimetic diabetes drugs can cause pancreatic cancer. Incretin mimetics treat type 2 diabetes by mimicking the action of GLP-1, a hormone that stimulates the pancreas to produce more insulin. In some patients, this could possibly cause chronic inflammation of the pancreas, also known as pancreatitis, which is a known risk factor for pancreatic cancer.
Pancreatic Cancer Treatment
Pancreatic cancer treatment options depend on the stage, size, and location of the tumor. Less than 20% of pancreatic cancers are detected before they metastasize (spread to other tissues), which is why long-term prognosis tends to be very poor. If the cancer is diagnosed before it has metastasized, surgery and chemotherapy are usually first-line treatment options. However, after the disease has spread, the goal of treatment is palliative care — improving quality of life for the patient by treating symptoms and complications.
Byetta Thyroid Cancer
The same 2011 Gastroenterology study that found an increased risk of pancreatic cancer with Byetta also found a 4.7-fold increased risk of thyroid cancer with the drug. The study was based on an analysis of FDA Adverse Event Reports (FAERs) submitted to the agency between 2004 and 2009. The study’s authors cautioned that this data does not prove Byetta causes thyroid cancer; however, it does indicate a link.
Thyroid Cancer Symptoms
- Lump in the neck
- Swollen lymph node
- Horse voice
- Difficulty swallowing or breathing
- Neck pain
- Throat pain
Byetta Side Effects
- Pancreatic inflammation
- Pancreatitis
- Chronic pancreatitis
- Acute pancreatitis
- Necrotizing pancreatitis
- Hemorrhagic pancreatitis
- Pancreatic cancer
- Thyroid cancer
- Kidney damage
- Low blood-sugar (hypoglycemia)
- Nausea
- Vomiting
- Diarrhea
- Decreased appetite
- And more
Byetta Timeline
Jun 2004 – Application submitted
June 30, 2004 – New Drug Application for exenatide submitted to FDA.
Sep 2004 – Application accepted
September 1, 2004 – Exenatide New Drug Application accepted.
Apr 2005 – Approved by the FDA
April 28, 2005 – Byetta first approved by the FDA.
Oct 2007 – Drug Safety Communication issued
October 2007 – FDA Drug Safety Communication issued over increased risk of acute pancreatitis with Byetta.
Aug 2008 – FDA warning updated
August 18, 2008 – FDA warning updated to include reports of necrotizing pancreatitis and hemorrhagic pancreatitis associated with Byetta.
Nov 2009 – Byetta approval expanded
November 2, 2009 – Byetta approval expanded for use as first-line treatment for type 2 diabetes.
Nov 2009 – Byetta labels changed
November 2, 2009 – Byetta labels changed to include information about reports of altered kidney function, including acute renal failure and insufficiency.
Jul 2011 – Gastroenterology study published
July 2011 – Study published in Gastroenterology finds that the development of pancreatic cancer in Byetta users is 3x greater than in patients treated with other diabetes medications.
Oct 2011 – Approved for use with insulin
October 20, 2011 – Byetta approved for use with insulin Glargine in the U.S.
Feb 2013 – JAMA Internal Medicine study published
February 25, 2013 – Study published in JAMA Internal Medicine finds that Byetta users are twice as likely to be hospitalized for pancreatitis.
Mar 2013 – FDA announces findings evaluation
March 14, 2013 – FDA announces that it is evaluating findings which suggest an increased risk of pancreatitis and pre-cancerous cellular changes (pancreatic duct metaplasia) associated with incretin mimetics.
2014 – AstraZeneca purchase
2014 – AstraZeneca purchases Bristol-Myers’ diabetes drug line.