European Health Authorities Launch Probe of Diabetes Drug Safety


europe-union-investigating-diabetes-drugOn Tuesday, the European Medicines Agency (EMA) announced that it has launched an investigation into recent findings that diabetes drugs made by Merck, AstraZeneca and others may cause precancerous changes in the pancreas.

The EMA, Europe’s leading drug watchdog, has begun its investigation following publication of an article suggesting that incretin mimetics, a class of Type 2 diabetes drugs, may lead to an increased risk of pancreatitis and precancerous cellular changes, Law360 reports. The study 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 before the study appeared in Diabetes, Law360 said. The agency had seen the findings from researchers at the University of California, Los Angeles medical school. The researchers examined pancreatic tissue specimens from 20 patients who had died from unspecified causes; they found evidence of cell damage in those who had taken incretin mimetics.

The EMA stressed that it had not yet reached any conclusions about the safety of the drugs, Law360 writes. 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 reports, 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.