The FDA has notified healthcare professionals and patients of revisions to the prescribing information for Merck's Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported cases of acute pancreatitis in patients using these products.
The agency has received 88 post-marketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis in patients using sitagliptin, between October 2006 and February of this year.
Therefore, the FDA is recommending that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin or sitagliptin/metformin. However, sitagliptin has not been studied in patients with a history of pancreatitis.
“[I]t is not known whether these patients are at an increased risk for developing pancreatitis and the medication should be used with caution and with appropriate monitoring in patients with a history of pancreatitis,” the agency said.