FDA reviewing new diabetes drugs due to pancreatic risk

WASHINGTON A group of new diabetes drugs is under investigation because it may increase the risk of pancreatic problems, including pancreatitis and cancer.

The Food and Drug Administration said Thursday samples of pancreas tissue taken from a small number of patients showed inflammation and cellular changes that often precede cancer. Academic researchers took the samples from diabetes patients who were taking the new medications, after they died from various causes.

Details of the research have not yet been published, but the agency said in an online statement it is seeking more information.

While the FDA has issued previous alerts about the pancreatitis risk, the agency had not notified the public about pre-cancerous cell changes seen with the drugs.

For now, regulators say they are still investigating the issue.

"FDA has not concluded these drugs may cause or contribute to the development of pancreatic cancer," the agency said in an online statement. "At this time, patients should continue to take their medicine as directed until they talk to their health care professional."

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The drugs under review come from a wave of recently approved diabetes medications, including Merck's Januvia and Janumet, Novo Nordisk's Victoza and Bristol-Myers Squibb's Byetta and Bydureon, among others. All the drugs mimic natural hormones that the body usually produces to spur insulin production after a meal.

GLP-1 mimickers like Victoza, Byetta and Bydureon are injected anywhere from twice a day to once a week. They allow the body to produce more insulin to lower blood sugar after a meal. Almost 1 million Americans take drugs these types of drugs.

DPP-4 inhibitors, taken by 1.6 million Americans, are pills taken once or twice a day to stimulate insulin production and limit the release of a hormone that raises blood sugar levels. Januvia and Janumet fall into this category.

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FDA reviewing new diabetes drugs due to pancreatic risk