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FDA reviews pancreas risks from new diabetes drugs

Daily News | March 15, 2013

Kevin Grogan

FDA reviews pancreas risks from new diabetes drugs

The US Food and Drug Administration is investigating reports of possible increased risk to the pancreas from using a class of diabetes drugs that includes blockbusters like Merck & Co's Januvia and Novo Nordisk's Victoza.

The agency is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis and pre-cancerous cellular changes called pancreatic duct metaplasia in patients treated with incretin mimetics. These findings "were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes", the FDA states, adding that it has asked the researchers to provide the methodology used to collect and study these specimens and tissue samples.

Drugs in the incretin mimetic class include Victoza (liraglutide), Januvia (sitagliptin), Eli Lilly's Byetta (exenatide), AstraZeneca/Bristol-Myers Squibb's Onglyza (saxagliptin), Takeda's Nesina (alogliptin) and Boehringer Ingelheim's Trajenta (linagliptin). The meeds work by mimicking the incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal.

The FDA went on to say it has not reached any new conclusions about safety risks with incretin mimetic drugs and thisearly communication is intended only to inform the public and healthcare professionals. However, it has previously warned the public about postmarketing reports of acute pancreatitis, including fatal and serious nonfatal cases, associated with the use of Byetta and Januvia.

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