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Europe Joins U.S. in Probing the Safety of Some Diabetes Drugs

Filed March 27th, 2013 edlieber1

The European Medicines Agency (EMA) has launched an investigation into recent findings that diabetes drugs made by companies including Merck & Co. Inc. and AstraZeneca PLC may cause precancerous problems. The move comes weeks after the U.S. Food and Drug Administration (FDA) announced a similar investigation.

The EMA is opening an investigation based on an article published in the medical journal Diabetes that suggested a class of Type 2 diabetes drug called incretin mimetics may be associated with an increased risk of pancreatitis and precancerous cellular changes known as pancreatic duct metaplasia, said.

Popular incretin mimetic drugs include AstraZeneca and Bristol-Myers Squibb Co.’s Byetta, Bydureon, Kombiglyze XR and Onglyza, Merck’s Januvia and Janumet, Boehringer Ingelheim GmbH and Eli Lilly & Co.’s Tradjenta, Novo Nordisk A/S’ Victoza and Takeda Pharmaceutical Co. Ltd.’s Nesina, Kazano and Oseni, law360 said. The drugs work by mimicking the incretin hormones that the body typically produces to generate the release of insulin in response to a meal. People with Type 2 diabetes take the drugs to help lower blood sugar.

The new findings were based on the study of a small number of pancreatic tissue specimens taken from patients after they died from unidentified causes, law360 said. At this time, the EMA has not made any changes to the recommendations on the use of these medicines, and there is no need for patients to stop taking their medicine. Both the EMA and FDA stressed that health care professionals should continue to prescribe these medicines in accordance with the product information.

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