Tuesday, February 26, 2013

After it is approved

Is when they find out how it really works.

Risk of pancreatitis doubles for those taking new class of diabetes drugs
In an article published online in JAMA Internal Medicine, the scientists say the new drugs—glucagon-like peptide-1-based therapies (GLP-1)—are associated with an increased risk of hospitalization for acute pancreatitis. The agents sitagliptin and exenatide—generic names for the drugs sold under the brand names Januvia and Byetta—appear to contribute to the formation of lesions in the pancreas and the proliferation of ducts in the organ, resulting in wellsprings of inflammation.

Physicians and regulators have been aware that pancreatitis could be a side effect of GLP-1 therapies, a risk that emerged in animal studies and reports to the U.S. Food and Drug Administration. But the Johns Hopkins investigators say their study is the first to accurately measure the strength of this risk in analyses that accounted for other pancreatitis risk factors, such as gallstones, obesity and heavy alcohol use.

"These agents are used by millions of Americans with diabetes. These new diabetes drugs are very effective in lowering blood glucose. However, important safety findings may not have been fully explored and some side effects such as acute pancreatitis don't appear until widespread use after approval," says study leader Sonal Singh, M.D., M.P.H., an assistant professor in the Division of General Internal Medicine at the Johns Hopkins University School of Medicine.
Nobody could have predicted...