The long-acting diabetes drug Bydureon has been linked to reports of serious injection-site reactions, which sometimes require surgical intervention, according to federal drug regulators.
Last month, the FDA approved new label changes for Bydureon, a long-acting version of the popular diabetes drug Byetta.
New warnings were added to the injectable diabetes drug about the risk of abscesses, cellulitis, and necrosis reported at injection sites. The label indicates that doctors should inform patients about the risk of such reactions, which can occur with or without subcutaneous nodules.
Bydureon (exenatide extended-release) was approved by the FDA in January 2012. It is a once-weekly injection version of Byetta, which was originally launched by Amylin. Both Bydureon and Byetta are now owned by AstraZeneca.
The new information under the “Warnings and Precautions” section of the label states:
“There have been postmarketing reports of serious injection-site reactions (e.g. abscess, cellulitis, and necrosis) with or without subcutaneous nodules, with the use of BYDUREON. Isolated cases required surgical intervention.”
The FDA has not issued a safety warning or provided further information about the reactions or injuries. However, the new labeling information tells doctors to educate patients about the risks of Bydureon injection site reactions and to advise them to seek medical advice if there are any signs of abscess, cellulitis, necrosis or if symptomatic nodules occur.
According to the new medication guide update, symptoms can include:
- Severe Pain
- An open wound
- A dark scab
Byetta and Bydureon Pancreatic Cancer Concerns
The two drugs belong to a larger class of diabetes medications known as incretin mimetics, which also includes Januvia, Janumet and Victoza.
The new injection site warnings come amid continuing concerns about the increased risk of pancreatitis and pancreatic cancer with Bydureon and other incretin mimetics.
Byetta (exenatide) was the first member of the incretin mimetic class of diabetes drugs, which was introduced by Amylin Pharmaceuticals in 2005 as a twice daily injection. Novo Nordisk introduced Victoza (liraglutide) in 2010, as a longer acting injectable diabetes drug, followed by Amylin’s Bydureon in January 2012.
The FDA initially rejected Bydureon in 2010, because the manufacturers failed to give strong enough assurances that patients would be safe from Bydureon health risks including kidney problems and hemorrhagic pancreatitis and necrotizing pancreatitis, which can be fatal and had already been linked to Byetta.
Januvia (sitagliptin) was introduced by Merck as an oral incretin mimetic diabetes drug in 2006, and has become one of the most widely used members of the class. A combination pill containing Januvia and the older diabetes medication metformin was introduced in 2007 under the brand name Janumet.
The manufacturers of these drugs now face hundreds of Byetta lawsuits, Januvia lawsuits, Janumet lawsuits and Victoza lawsuits filed throughout the United States by individuals who claim that they were diagnosed with pancreatic cancer after using the diabetes drugs.