The European Medicines Agency is following a move by its counterpart across the Atlantic and is investigating the possibility of an increased risk to the pancreas linked to use of new diabetes drugs.
Specifically, the agency is investigating findings “by a group of independent academic researchers” that suggest an increased risk of pancreatitis and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with glucagon-like peptide 1 (GLP-1) agonists and dipeptidylpeptidase-4 (DPP-4) inhibitors. The findings are based on examination of “a small number of pancreatic tissue samples obtained from organ donors with and without diabetes mellitus, who died due to causes other than diabetes”.
GLP-1-based therapies, also known as incretin mimetic, include Novo Nordisk’s Victoza (liraglutide), Merck & Co’s Januvia (sitagliptin), Eli Lilly’s Byetta (exenatide), AstraZeneca/Bristol-Myers Squibb’s Onglyza (saxagliptin), Takeda’s Nesina (alogliptin) and Boehringer Ingelheim’s Trajenta (linagliptin). The review mirrors a similar probe announced by the US Food and Drug Administration a fortnight ago.
The EMA noted that it has not reached any conclusions on this investigation yet and there is currently no change to the recommendations on the use of these medicines and no need for patients to stop taking them.
