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FDA Evaluates Diabetes Meds, Cancer Links

Filed March 15th, 2013 admin

The U.S. Food and Drug Administration (FDA) has been made aware of new evidence that indicates a group of recently approved diabetes drugs may increase risks for pancreatitis and pancreatic cancer

The FDA said samples of pancreas tissue taken from a small number of patients revealed inflammation and cellular changes that frequently pave the way for cancer. Academic researchers took the samples from diabetes patients who were taking the new medications, after they died from various causes, The Associated Press (AP) said the FDA said in an online statement that it is investigating the issue and seeking more information.

The drugs under review include Merck’s Januvia and Janumet, Novo Nordisk’s Victoza and Bristol-Myers Squibb’s Byetta and Bydureon, among others, the AP said. Each of the drugs simulates natural hormones that the body typically produces to prompt insulin production after a meal.

The FDA has issued previous alerts regarding the pancreatitis risk, but this marks the first time the public has been notified about pre-cancerous cell changes found with the drugs, the AP said. The FDA added information about cases of pancreatitis to the labels of Byetta in 2007, and Januvia and Janumet in 2009. The FDA cited a recent study of insurance records found that use of those drugs could double the risk of developing acute pancreatitis, said the AP. For now, regulators say they are still investigating the issue. The agency is advising patients to continue to take their medicine as directed until they talk to their health care professional.

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