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Byetta Studies

Byetta Studies

Recent studies have found that patients who take Byetta may have higher rates of pancreatitis (pancreas inflammation), pancreatic cancer, and thyroid cancer.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Byetta induced injury cases in all 50 states. If you or somebody you know was diagnosed with pancreatic cancer or thyroid cancer, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

Study Finds Pancreatic Cancer Risk

Researchers published a study in the journal Diabetes in which they autopsied pancreases from 20 people with diabetes who died of head injuries or strokes. Of those patients, 12 used incretin therapy diabetes drugs, including one who used Byetta.

Researchers compared the pancreases and found evidence of abnormal cell proliferation in patients on incretin drugs. The cells were growing in unusual patterns around the pancreatic duct, which is where most pancreatic cancers start.

The patient on Byetta had a microadenoma, which is a benign tumor that can become cancerous. People who are diagnosed with adenomas typically need immediate surgery. At the very least, researchers said patients might have a higher risk of needing surgery:

“Moreover, since the standard of care of a pancreatic neuroendocrine tumor, because of the risk of conversion to malignancy, even if benign, is surgical resection [i.e. removal], patients exposed to incretin therapy would seem to be at increased risk of requiring pancreatic surgery.”

The study is Marked Expansion of Exocrine and Endocrine Pancreas with Incretin Therapy in Humans with increased Exocrine Pancreas Dysplasia and the potential for Glucagon-producing Neuroendocrine Tumors. Alexandra E Butler et al. Published online before print March 22, 2013, doi: 10.2337/db12-1686. Diabetes March 22, 2013

Pancreatitis Studies

Numerous studies and dozens of case reports have identified pancreatitis as a potential risk of Byetta. In 2007 and 2008, the FDA published Safety Communications to warn about pancreatitis. In May 2010, Annals of Pharmacotherapy published a study that also linked Byetta to a risk of pancreatitis. When the study was published, there were 8 known cases of pancreatitis in clinical trials, and 36 case reports submitted to the FDA.

Gastroenterology Study Finds Risk of Pancreatic/Thyroid Cancer

One of the most striking and controversial studies of Byetta was published in Gastroenterology in 2011. This study was conducted by researchers at UCLA who investigated the risk of pancreatitis, pancreatic cancer, and thyroid cancer associated with Byetta.

They analyzed adverse events that were submitted to the FDA between 2004 and 2009. Although there are limitations to this voluntary reporting system, a large number of adverse events can signal potential risks that should be studied further.

The study found reports for the following serious injuries in Byetta patients:

  • Pancreatitis: Inflammation of the pancreas; 971 case reports and an 11-fold odds ratio
  • Pancreatitis (before 2006): 152 case reports and a 2.6-fold odds ratio
  • Pancreatic cancer: 81 case reports and a 3-fold odds ratio
  • Thyroid cancer: 30 case reports and a 4.7-fold odds ratio
  • All cancers: Including thyroid and pancreatic cancers; 375 case reports, 1.1-fold odds ratio

Gastroenterology first published the study online in February 2011. Within weeks, Amylin Pharmaceuticals and Eli Lilly sent a letter to the editor-in-chief. They were concerned that the researchers might spark an unnecessary health scare with “unjustified” conclusions. In response, Gastroenterology withdrew the study.

“This analysis of the FDA database does not establish that pancreatitis, pancreatic cancer and thyroid cancer are caused by GLP-1 therapy. It simply raises the level of concern that they may be, and that the appropriate prospective studies are required to rule them out.”

FDA Requires More Byetta Studies

In 2009, the FDA requested six additional studies to investigate the risk of pancreatic cancer and thyroid cancer. It is likely that these studies will take many years to complete. Thyroid cancer and pancreatic cancer are relatively rare types of cancer that can take years to develop. Furthermore, diabetes itself is a risk factor for developing pancreatic cancer and possibly thyroid cancer.

Do I have a Byetta Lawsuit?

The Schmidt Firm, PLLC is currently accepting Byetta induced injury cases in all 50 states. If you or somebody you know was diagnosed with pancreatic cancer or thyroid cancer, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

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