About 92,000 vials of the type 2 diabetes drug Bydureon are being recalled throughout Europe because some of the vials of the long-acting medication were not fully filled. Bydureon is a weekly injectable version of the drug exenatide. It is the same medication in the type 2 diabetes drug Byetta.
The affected drug, jointly marketed by AstraZeneca and Bristol-Myers Squibb Co., was recalled from the Netherlands, Ireland, Sweden, Finland and Spain. No Bydureon vials sold in the United States are affected. Spokesmen for the companies say that injecting under-filled vials should not pose any health concerns to patients.
Bydureon has a black box warning that tests on laboratory animals given the drug have shown there is a risk for cancerous thyroid tumors. The drug is in a class of type 2 diabetes medications known as incretin mimetics that also include widely prescribed drugs such as Januvia.
Recent studies have shown that incretin mimetics increases the risk for serious pancreatic problems including acute pancreatitis and pancreatic cancer. The greatest risk was seen with the type 2 diabetes drugs Januvia and Byetta.
Bristol-Myers Squibb and AstraZeneca took over Bydureon during Bristol-Myers’ $5.3 billion acquisition of Amylin Pharmaceuticals last summer. Bydureon had sales of $118 million in the first six months of 2013, which also includes sales in the United States.