Januvia, Janumet to Note Pancreatitis Cases
FDA Wants Reports of Acute Pancreatitis in Prescribing Information for Diabetes Drugs Januvia and Janumet
Sept. 25, 2009 -- The FDA wants the maker of the type 2 diabetes drugs
Januvia and Janumet to change the prescribing information to note reports of
acute pancreatitis, a potentially life-threatening pancreas problem.
The FDA today announced that it has gotten reports of 88 people taking those
drugs who developed acute pancreatitis between Oct. 16, 2006, and Feb. 9,
Those cases include two cases of hemorrhagic pancreatitis (inflammation of
the pancreas with bleeding) or necrotizing pancreatitis (in which the inflamed
pancreas destroys itself).
Januvia and Janumet both include the active ingredient sitagliptin; Janumet
also includes another drug, metformin. Today's FDA announcement focuses only on
FDA's Advice to Patients, Doctors
The FDA has this advice for patients taking Januvia or Janumet:
- Be aware that acute pancreatitis has been reported in patients using
Januvia or Janumet.
- Pay close attention for any signs or symptoms of pancreatitis, such as
nausea, vomiting, not eating, and persistent severe abdominal pain, which may
radiate to the back.
- Promptly discuss any signs and symptoms of pancreatitis with a health care
- Do not stop or change medicines that have been prescribed without first
talking with a knowledgeable health care professional.
The FDA has asked Merck, the drug company that makes Januvia and Janumet, to
make the following changes to the drugs' prescribing information:
- Note the reports of acute pancreatitis, including the severe forms of
hemorrhagic or necrotizing pancreatitis
- Recommend that health care professionals monitor patients carefully for
signs of pancreatitis when starting patients on either drug or increasing doses
of those drugs, and to discontinue those drugs in patients with suspected
- Note that sitagliptin hasn't been studied in patients with a history of
In a statement, Merck says it has reviewed data from its preclinical studies
and clinical trials of sitagliptin and didn't see any link between sitagliptin
and acute pancreatitis.
Merck says it also checked its postmarketing adverse event reports and found
that the data don't prove that sitagliptin caused pancreatitis.
Merck also points out that people with type 2 diabetes are more likely
to develop pancreatitis than other people, and that patients taking Januvia or
Janumet who experienced more severe forms of pancreatitis "also had other
serious medical conditions."
Merck says it added pancreatitis to the postmarketing adverse events section
of the labeling for Januvia and Janumet earlier this year. Pancreatitis has
been reported in people using many other prescription drugs, including other
diabetes drugs, Merck notes.