Type 2 diabetes drug adds new warning for serious injection site reactions

diabetes illus250x03 Type 2 diabetes drug adds new warning for serious injection site reactionsNew information has been added to the safety label of the injectable type 2 diabetes drug Bydureon to include a new warning that some people using the medication have experienced serious injection-site reactions, some of which have required surgical intervention.

The new Injection-Site Reaction information was added to both the Warnings & Precautions and the Adverse Events sections of the medication, and new information was added to the patient counseling information and medication guide.

Injection-site reactions reported include abscess, cellutitis and necrosis, with or without bumps, or nodules. Patients are advised to contact their health care provider immediately if they experience severe pain, swelling, blisters, an open wound or a dark scab at the site where Bydureon is injected.

Bydureon is an extended-release version of the brand name type 2 diabetes drug Byetta. Both are injectable drugs and contain the active ingredient exenatide, known as a GLP-1 receptor agonist in a class of diabetes medications known as incretin mimetics.

A recent study by AdverseEvents, a company that analyzes post-market side effects data, found that incretin mimetics drugs were associated with serious side effects, including cancer risks. Byetta, along with Victoza, Janumet and Januvia, were associated with an increased risk of pancreatic cancer and acute pancreatitis.

People with type 2 diabetes are at an increased risk for serious health problems including heart disease, kidney disease, blindness, neuropathy, and dementia. These patients are also two times as likely as people without type 2 diabetes to develop pancreatic cancer, a disease that kills 94 percent of its victims within five years.

Source: FDA