As we noted back on September 25, 2009, post-marketing reports are emerging of increased risk of pancreatitis for patients taking Janumet® and Januvia® (sitagliptin).
I took almost a full-quarter-year, but the label copy was apparently finally agreed to before year-end, and just made available (as a PDF file) on FDA's website as of January 6, 2010. Here is the newly-added bit:
. . . .5.2 Pancreatitis
There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, in patients taking JANUMET. After initiation of JANUMET, patients should be observed carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, JANUMET should promptly be discontinued and appropriate management should be initiated. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUMET. . . .
This drug, along with Januvia, is still a $2 billion in annual revenues franchise for New Merck.
