Byetta FDA Warning & Approval Information

Byetta (exenatide) is a diabetes injection “pen” that was approved in 2005. Since then, the U.S. Food and Drug Administration (FDA) has strengthened warnings to include potential risks of pancreatitis and kidney failure. In addition, the FDA has warned that drug-makers are investigating potential links between Byetta and pancreatic cancer and thyroid cancer.

Do I Have a Texas Byetta Lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured by Byetta, you should contact our lawyers immediately. You may be entitled to compensation by filing a Byetta lawsuit in Texas.

When did the FDA approve Byetta?

Byetta (exenatide) was first approved by the FDA on April 28, 2005. It is manufactured by Amylin Pharmaceuticals Inc. and Eli Lilly & Co. Click here to read more about Byetta FDA approval information.

FDA Safety Warnings for Byetta

The FDA has published three Drug Safety Communications involving Byetta (exenatide). More than 7 million prescriptions have been written for this anti-diabetes drug. It is used in addition to diet and exercise to improve blood-sugar control in adults with type-2 diabetes mellitus. Unfortunately, the FDA has received more than 1,000 reports of serious adverse events associated with Byetta, including at least 6 deaths.

The following Byetta FDA warnings have been published:

FDA Safety Warning for Byetta and Pancreatitis

The warnings for Byetta has included information about pancreatitis since 2007. Although cause an effect has not been established, an association is suspected. People with diabetes are already about three times more likely to develop pancreatitis than the general population, and certain diabetes medications could increase this risk even further.

In October 2007, the FDA reported receiving 30 reports of acute pancreatitis in patients taking Byetta. This disease is characterized by sudden, severe inflammation of the pancreas, an organ that produces hormones and digestive enzymes. Most of the patients required hospitalization.

New FDA warnings for Byetta include:

  • Healthcare providers should be alert to the signs and symptoms of acute pancreatitis. Symptoms may include persistent severe abdominal pain, which may be accompanied by nausea and/or vomiting.
  • Discontinue Byetta if pancreatitis is suspected.
  • Byetta patients should seek emergency medical care if they experience unexplained severe abdominal pain with or without nausea and vomiting.
  • Byetta should not be re-started.

In August 2008, the FDA updated the warning to announce an additional 6 reports of hemorrhagic or necrotizing pancreatitis. This occurs when the pancreas begins bleeding. Pancreatic tissue can also die (necrotize), which increases the risk of infection, organ failure, and death. At least 6 deaths have been attributed to severe forms of pancreatitis.

FDA Safety Warning for Byetta and Kidney Failure

The FDA has issued a warning for kidney failure after receiving 78 cases of altered kidney function in patients who used Byetta between April 2005 and October 2008. These reports included 62 cases of acute kidney failure, 16 cases of renal insufficiency, and 4 deaths. More than 90% of the patients required hospitalization. Unfortunately, only 39 patients (50%) reported improved symptoms after stopping Byetta.

FDA Safety Warning for Byetta and Pancreatic Cancer, Thyroid Cancer

The FDA has not issued a specific warning about the risk of cancer in Byetta patients. However, in 2009, the FDA published a Safety Update for Healthcare Providers, in which they announced that Amylin Pharmaceuticals must conduct six post-marketing surveillance studies to investigate the potential risk of pancreatic cancer and thyroid cancer. The FDA may have required these studies because they received more than 100 reports of thyroid cancer and pancreatic cancer in Byetta patients before 2009.

Do I have a Byetta Lawsuit in Texas?

Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $60 million in verdicts and/or settlements. Please use the form below to contact us for a free Texas Byetta lawsuit review.