Quoted from http://www.reuters.com/article/governmentFilingsNews/idUSN2550919420090925
US FDA sees pancreatitis link with Merck's Januvia
WASHINGTON, Sept 25 (Reuters) - U.S. health officials said on Friday they suspect Merck & Co Inc's diabetes drug Januvia may be linked to serious cases of pancreatitis, but company officials disputed the connection.
The Food and Drug Administration said that 88 cases of acute pancreatitis had been reported since the drug's approval in 2006 through February 2009.
Because a number of patients developed the condition soon after taking Januvia, or related drug Janumet, and about half saw it disappear after they stopped using it, "FDA believes there may be an association" with the drug.
But Dr. John Amatruda, a Merck senior vice president for diabetes products, said "We don't believe that the data establishes a relationship."
Both Januvia and Janumet contain the active ingredient sitagliptin.
The FDA said it was working with Merck to add information about the cases to the drugs' labels. (Reporting by Susan Heavey; Editing by Tim Dobbyn)