FDA: Merck's Januvia May Have Pancreatitis Risk

NEW YORK (AP) — The Food and Drug Administration said on Friday that there may be a connection between Merck & Co.'s diabetes treatment Januvia and occurrences of acute pancreatitis, the same issue that sunk sales of Amylin Pharmaceuticals Inc.'s Byetta.

Still, the agency reaffirms it is unclear whether the connection is between the treatment and pancreatitis or whether diabetes patients in general are at an increased risk.

The FDA said there were 88 cases of acute pancreatitis reported in Januvia patients between October of 2006 and February of 2009. The agency is working with Merck to include new warning information on the drug's label.

"It is recommended that health care professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases," the agency said, in a statement.

The agency said the medication should be used with caution and with appropriate monitoring in patients with a history of the condition.

"Because acute pancreatitis is associated with considerable morbidity and mortality, and early recognition is important in reducing adverse health outcomes, FDA is recommending revisions to the prescribing information to alert health care professionals to this potentially serious adverse drug event," the agency said.