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FDA Probes Pancreatic Cancer Risk with Diabetes Drugs Januvia, Byetta and Victoza

Mar 15, 2013

The U.S. Food and Drug Administration (FDA) is examining new evidence that suggests a group of recently approved diabetes drugs, including Januvia, Byetta and Victoza may have a link to pancreatic cancer.

In a March 14 Drug Safety Communication, the agency said samples of pancreatic tissue taken from a number of patients showed inflammation and cellular changes that often precede cancer. The tissue samples came from diabetes patients who were taking the new medications, after they died from various causes, the Associated Press (AP) reports.

The drugs under review are in the incretin mimetic class, which mimic the natural hormones that stimulate insulin production after a meal. They include Byetta and Bydureon (exenatide); Victoza (liraglutide); Januvia, Janumet, Janumet XR, and Juvisync (sitagliptin); Onglyza and Kombiglyze XR (saxagliptin); Nesina, Kazano, and Oseni (alogliptin); and Tradjenta and Jentadueto (linagliptin). These drugs are used along with diet and exercise to lower blood sugar in adults with Type 2 diabetes, the FDA says.

Pancreatitis causes an inflammation of the pancreas and can lead to fatal complications, including difficulty breathing and kidney failure. While the FDA has issued alerts about the pancreatitis risk, the agency had not previously notified the public about pre-cancerous cell changes seen with the drugs, the AP said. “FDA has not concluded these drugs may cause or contribute to the development of pancreatic cancer,” the agency said in the safety communication. “At this time, patients should continue to take their medicine as directed until they talk to their health care professional.”

People with Type 2 diabetes are unable to properly break down carbohydrates and many diabetics require multiple drugs with different mechanisms of action to control their blood sugar levels, the AP writes. The FDA reports that a recent study of insurance records found that use of those drugs could double the risk of developing acute pancreatitis.

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