FDA Looking at the Safety of GLP-1 Diabetes Drugs

Yet again, FDA is looking closer at the safety of diabetes drugs, this time a group of relatively new drugs often called GLP-1 agonists. Late yesterday, the agency announced it is “evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes.”

This announcement comes shortly after the publication of a study by investigators from Johns Hopkins. They found a significantly increased risk of hospitalization for acute pancreatitis associated with the use of sitagliptin and exenatide for diabetes. Sitagliptin and exenatide, sold under the brand names of Januvia and Byetta, are both GLP-1 agonists.

An increased risk of pancreatitis is something that FDA had previously included in warnings to patients and physicians for diabetes drugs in this class. FDA emphasized that the agency “has not reached any new conclusions about safety risks” of these medicines and they urged consumers to continue to take the medications as prescribed.

This news illustrates the high level of scrutiny FDA is applying to diabetes drugs and the challenges faced by companies developing new diabetes treatments. In 2010, FDA severely restricted the use of the widely used diabetes drug, Avandia, and imposed tough new standards for testing the cardiovascular safety of new treatments. More recently, FDA overruled its expert advisory board and denied approval for a new long-acting insulin, degludec, until its sponsor conducted a large cardiovascular safety trial.

Click here to read more in the Los Angeles Times, here to read more in the Wall Street Journal, here to access the study from Johns Hopkins, and here to read the FDA Drug Safety Communication.

The Pancreas, image from Gray’s Anatomy (1918) / Wikimedia

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