EU Health Authorities Launch Probe into Safety of Diabetes DrugMar 27, 2013
The European Medicines Agency (EMA) announced on Tuesday that it has begun an investigation into findings that diabetes drugs made by Merck, AstraZeneca and others may cause precancerous changes in the pancreas.
The EMA, Europe’s top drug watchdog, is basing its investigation on an article suggesting that a class of Type 2 diabetes drug, incretin mimetics, may lead to an increased risk of pancreatitis and precancerous cellular changes, Law360 reports. The article was published last week in the journal Diabetes.
Incretin mimetic drugs include AstraZeneca and Bristol-Myers Squibb’s Byetta, Bydureon, Kombiglyze XR and Onglyza; Merck's Januvia and Janumet; Boehringer Ingelheim and Eli Lilly's Tradjenta; Novo Nordisk’s Victoza; and Takeda Pharmaceutical's Nesina, Kazano and Oseni. These drugs mimic the natural hormones that stimulate the release of insulin in response to a meal. The drugs are used to help lower blood sugar in adults with Type 2 diabetes.
The U.S. Food and Drug Administration (FDA) announced its own investigation on March 14, just prior to the study’s publication in Diabetes, Law360 said. The study’s findings were based on UCLA medical school researchers’ examination of pancreatic tissue specimens from 20 patients who had died from unspecified causes.
In its statement, the EMA stressed that it had not reached any conclusions about the safety of the drugs, Law360 reported. The agency's Committee for Medicinal Products for Human Use and its Pharmacovigilance Risk Assessment Committee are conducting the probe “to determine the need for possible further regulatory action.”
For patients taking incretin mimetics, Law360 reported, the EMA’s recommendations echo those of the FDA. There is “no need for patients to stop taking their medicines. Health care professionals should continue to prescribe these medicines in accordance with the product information,” the EMA said.