FDA To Update Merck's Januvia Label On Pancreatitis
September 25 2009 - 1:05PM
Dow Jones News
The Food and Drug Administration said Friday it was updating the
labels of Merck & Co.'s (MRK) diabetes drugs Januvia and
Janumet to discuss reports of acute pancreatitis seen in some
patients.
The FDA said it's seen 88 reports of acute pancreatitis in
patients using Januvia or Janument between October 2006 and
February 2009. Of those, 58 patients had to be hospitalized and two
patients had a more serious case of pancreatitis and were admitted
to the intensive care unit.
The agency said 19 cases occurred within 30 days of starting
treatment with either drug and that 47 of 88 cases resolved when
drug treatment was stopped. The agency noted that 45 patients had
at least one risk factor for developing pancreatitis such as
diabetes, obesity and high cholesterol.
The agency said in a notice posted to its Web site, "FDA
believes there may be an association between these events" and
Januvia or Janumet.
In a statement, Merck said it conducted a safety review of
clinical trials that involved more than 6,000 patients as well as
post marketing reports.
"Merck believes these data do not demonstrate that a causal
relationship exists between [Januvia] and pancreatitis," the
company said.
John Amatruda, the diabetes franchise head for Merck Research
Laboratories, said people with type 2 diabetes are more likely to
develop pancreatitis than the general population.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com