Januvia, Janumet to Note Pancreatitis Cases
Januvia, Janumet to Note Pancreatitis Cases
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, 2009.
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 sitagliptin.
The FDA has this advice for patients taking Januvia or Janumet:
The FDA has asked Merck, the drug company that makes Januvia and Janumet, to make the following changes to the drugs' prescribing information:
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.
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, 2009.
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 sitagliptin.
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 professional.
- 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 pancreatitis
- Note that sitagliptin hasn't been studied in patients with a history of pancreatitis
Merck Responds
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.
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