WASHINGTON (AP) -- The European Medicines Agency said Friday it uncovered no new evidence of pancreas-related safety issues after reviewing a group of recently approved diabetes drugs.
The agency's Committee for Medicinal Products for Human Use reviewed the safety of so-called GLP-1 diabetes therapies after a study suggested they increase the risk of pancreatitis and cellular changes that precede pancreatic cancer.
The drugs reviewed represent a wave of recently approved diabetes treatments, including Merck's Januvia and Janumet, Novo Nordisk's Victoza and Bristol-Myers Squibb's Byetta and Bydureon, among others. All the drugs mimic natural hormones that the body usually produces to spur insulin production after a meal.
After reviewing the study by independent researchers, European regulators say that "the study itself had a number of methodological limitations and potential sources of bias."
The scientists also looked at all clinical and nonclinical research data available on the drugs, and concluded: "There is no change in evidence regarding the risks of pancreatic adverse events associated with the use of GLP-1 based therapies."
The U.S. Food and Drug Administration launched its own investigation based on the same concerns in March. The agency has not yet issued any statement on its review.
The pancreas produces various hormones, including insulin, that help the body break down sugar. Pancreatitis is an inflammation of the organ and can lead to fatal complications, including difficulty breathing and kidney failure.
Whitehouse Station, N.J.-based Merck & Co. Inc. issued a statement Friday following the European agency's announcement.
"Nothing is more important to us than the safety of our medicines and the people who take them. We appreciate the important role that the EMA and its CHMP play in monitoring the safety of medicines in Europe," said Merck Executive Vice President, Michael Rosenblatt.
