Pharmaceutical

European drug regulators investigate pancreas risks with popular type 2 diabetes drugs

diabetes illus250x03 European drug regulators investigate pancreas risks with popular type 2 diabetes drugsThe European Medicines Agency is investigating whether a class of type 2 diabetes medications increases the risk of pancreatitis (inflammation of the pancreas) and precancerous cellular changes called pancreatic-duct metaplasia.

The investigation involves so-called GLP-1-based therapies (glucagon-like-peptide-1) agonists and dipeptidylpeptidase-4 (DPP-4) inhibitors. GLP-1 therapies are also known as incretin mimetics and include the drugs exenatide (Byetta, Bydureon), liraglutide (Victoza), lixisenatide (Lyxumia), sitagliptin (Efficib, Januvia, Janumet, Ristaben, Ristfor, Tesavel, Velmetia, Xelevia), saxagliptin (Komboglyze, Onglyza), linagliptin (Jentadueto, Trajenta), and vildagliptin (Eucreas, Galvus, Icandra, Jalra, Xiliarx, Zomarist).

The investigation comes just days after the U.S. Food and Drug Administration (FDA) announced it was investigating the same class of type 2 diabetes medications for pancreas risks.

Both investigations stem from unpublished findings by a group of academic researchers who examined a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes.

Neither the FDA nor the EMA has reached any conclusions from their investigations into the drugs, but say they will keep the public informed on their findings.

Drugs to treat type 2 diabetes have come under closer review in recent years. For example, in 2010, the FDA severely restricted the use of Avandia after it was linked to fatal heart attacks. In 2011, the agency warned that Actos had been linked to cases of bladder cancer.

Source: PharmPro