Diabetes drugs get FDA nod

2/26/2014

By The Associated Press

By The Associated Press

People who take Januvia, Byetta or certain other widely prescribed medicines for diabetes can breathe a little easier — U.S. and European regulators have found no compelling evidence of a link between these drugs and pancreas problems or pancreatic cancer.

The federal Food and Drug Administration and its European counterpart started reviews last year of these medicines, which came on the market less than a decade ago, after a study suggested a safety concern.

More than 25 million Americans and 33 million people in Europe have Type 2 diabetes, which impairs production or use of insulin to break down food into energy. That causes blood sugar to rise, putting them at risk of heart and other problems.

The drugs in question, called GLP-1 medicines, help spur insulin production after meals. Nine are approved in Europe and seven in the U.S., including include Merck's Januvia and Janumet, Novo Nordisk's Victoza and Bristol-Myers Squibb's Byetta and Bydureon.

The labels for Byetta, Januvia and Janumet already have information about the possibility of pancreatic inflammation. A study of insurance records had suggested GLP-1 drugs could double this risk.

In July, the European Medicines Agency said its review had found no new evidence of pancreas problems.

On Wednesday, the New England Journal of Medicine published a report from scientists in Europe and at the FDA saying reviews of animal and human studies, plus new studies commissioned to look at this risk, had found no treatment-related adverse effects on the pancreas.

Although the review "provides reassurance," the agencies "have not reached a final conclusion" about whether the drugs can cause pancreas problems and will "continue to investigate this safety signal," the authors write.

Meanwhile, the drugs' labels appear adequate, the agencies conclude.

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