Byetta Diabetes Drug Linked with Fatal Pancreatitis
Update: A paper published about the possible risk of pancreatitis and pancreatic cancer in Byetta patients raises concerns over the safety of incretin therapies. Peter Butler, MD, of the University of California Los Angeles and some of his colleagues based their findings on data from the FDA’s Adverse Event Reporting System (AERS).
According to the paper, patients treated with Januvia (sitagliptin) or Byetta (exenatide) were six times more likely to report pancreatitis between 2004 and 2009. Researchers also said these patients were three times more likely to report pancreatic cancer and those being treated with Byetta were four times more likely to report thyroid cancer.
These findings raise concerns among researchers who say more studies are needed to determine the risk of cancer in these patients.
Serious Risks Associated with Byetta
The Food and Drug Administration (FDA) is alerting Byetta users to serious risks associated with use of the under-fire diabetes drug. Federal regulators are seeking implementation of stronger labels for Byetta, which may mean issuing a black box warning, the most serious warning label required by the FDA.
Byetta, the brand name for exenatide, is a twice-daily diabetes drug developed and marketed by Amylin Pharmaceuticals Inc. and Eli Lilly & Co for the treatment of type 2 diabetes. Gaining FDA approval in 2005, Byetta is designed to lower the blood glucose levels of diabetes patients.
Byetta is one of Amylin Pharmaceuticals’ best selling drugs, with worldwide sales of exceeding $650 Million in 2007.
Byetta and Pancreatitis
Use of Byetta has been linked with increased risk of hemorrhagic or necrotizing pancreatitis. In October 2007, a total of 30 cases of Byetta-related pancreatitis were reported to the FDA. Although these cases did not result in any deaths, Amylin Pharmaceuticals issued an alert to doctors and patients, and updated their labels to include additional information related to Byetta pancreatitis risks.
On August 18th, 2008, The FDA received six new reports of Byetta-related pancreatitis. Unlike the 30 cases reported in 2007, there were two deaths associated with the 2008 incidents. The manufacturers of Byetta were quick to respond to the FDA report by acknowledging the increased, albeit rare, potential for pancreatitis associated with the use of the diabetes drug. However, Amylin and Eli Lilly were quick to point out that people suffering from diabetes are already at increased risk of suffering pancreatitis.
With more than 700,000 diabetes sufferers using Byetta worldwide, FDA officials are hoping to spread the word about the potentially fatal Byetta side effect before any more people are hurt. Patients using Byetta are advised to consult with their doctor immediately and cease use of the drug if signs of acute pancreatitis are exhibited. These signs can include (but are not limited to):
- Abdominal / back pain
- Bruising of the lower back and/or navel
- Abnormally foul smelling, pale, oily feces
If you or a loved one has been injured as a result of using Amylin Pharmaceuticals’ and Eli Lilly & Co’s Byetta diabetes drug, you may be entitled to receive compensation for your pain and suffering. Drug manufacturers are responsible for ensuring the safety and efficacy of their products before marketing them for public consumption. Failure to adequately do so, or failure to warn consumers of the risks associated with use of a possibly defective drug is considered negligent and can be grounds for personal injury litigation.
The Pensacola personal injury attorneys of Aylstock, Witkin Kreis & Overholtz handle national litigation across the United States for victims injured by defective pharmaceuticals and medical devices. Contact the lawyers of AWKO law today at 888 255 2956 to get information about your rights as a Byetta injury victim.