FDA Studying Possible Cancer Risk of Anti-Diabetes Drugs


The U.S. Food and Drug Administration said Thursday it was reviewing results of unpublished studies hinting at higher risks of ulcers and pancreatic cancer for users of certain anti-diabetes drugs.

The FDA said pancreatic tissue samples taken from a small number of patients who died had revealed inflammation and cellular changes that often precede cancer.

The samples were taken from deceased diabetics who had used medicines that mimic incretin hormones that the body produces naturally to stimulate the release of insulin in response to a meal.

The FDA stressed it had not reached any firm conclusions from the findings of the study, adding that it had requested further information such as the methodology used so it could further analyze the potential toxicity of the anti-diabetes drugs known as incretin mimetics.

The anti-diabetic drugs at the center of the findings include Onglyza (saxagliptin), produced by U.S. pharmaceutical company Bristol-Myers Squibb Co and Victoza (liraglutide), from the Danish company Novo Nordisk.

"FDA has not reached any new conclusions about safety risks with incretin mimetic drugs," the agency said in a statement.

"This early communication is intended only to inform the public and health care professionals that the agency intends to obtain and evaluate this new information."

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