FDA probes pancreas risks of diabetes drugs
The agency said Thursday samples of pancreas tissue taken from a small number of patients showed inflammation of the pancreas 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.
The details of the research have not yet been published, but the agency said in an online statement it is seeking more information.
The drugs under review come from a wave of recently approved diabetes medications, including Merck & Co. Inc.'s Januvia and Janumet, Novo Nordisk's Victoza and Bristol-Myers Squibb's Byetta and Bydureon, among others. All the drugs mimic a natural hormone that the body usually produces to spur insulin production after a meal.
People with type 2 diabetes are unable to properly break down carbohydrates, either because their bodies do not produce enough insulin or because they've become resistant to the hormone, which controls blood sugar levels. These patients are at higher risk for heart attacks, kidney problems, blindness and other serious complications.
Many diabetics require multiple drugs with different mechanisms of action to control their blood sugar levels.
With more than 25 million people living with diabetes in the U.S., some of the world's biggest drugmakers have launched new treatments in recent years, though safety questions have emerged.
The FDA previously added information about cases of pancreatitis, some of them fatal, to the labels of Byetta, Januvia and Janumet.
A recent study of insurance records found that use of those drugs could double the risk of developing acute pancreatitis, according to the FDA.
The pancreas produces various hormones, including insulin, that help the body break down sugar. Pancreatitis causes an inflammation of the organ and can lead to fatal complications, including difficulty breathing and kidney failure.
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."
Shares of Whitehouse Station, N.J.-based Merck & Co. Inc. fell 60 cents to $43.99 in midday trading.
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