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FDA warns of acute pancreatitis cases in patients receiving sitagliptin
Eighty-eight postmarketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis were reported between October 2006 and February 2009 in patients taking sitagliptin, a DPP-IV inhibitor, the FDA reported today.
The agency announced it is working with the manufacturer to revise prescribing information for sitagliptin (Januvia, Merck) and sitagliptin/metformin (Janumet, Merck) to include the following:
- Recommendations for health care professionals to monitor patients for pancreatitis after they receive initial doses or increases in doses of the medications and to discontinue use if pancreatitis is suspected.
- Information regarding postmarketing reports of acute pancreatitis, including the severe forms mentioned above.
- A notification that it is unknown whether patients with a history of pancreatitis are at increased risk for developing the illness, as it has not been studied in this patient population, as well as a warning to use caution in patients who have experienced pancreatitis before.
In response to the FDA report, Merck issued the following statement from John Amatruda, MD, senior vice president and franchise head of diabetes and obesity at Merck Research Laboratories: “Merck has thoroughly reviewed the safety data for sitagliptin, and sitagliptin was not associated with an increase in the incidence of pancreatitis in preclinical studies or in clinical trials of up to two years in duration with more than 6,000 patients. Merck has also carefully reviewed postmarketing adverse experience reports, and Merck believes these data do not demonstrate that a causal relationship exists between sitagliptin and pancreatitis.”
In a press release, the company said in its review of the pancreatitis reports, the more serious cases also had other serious medical conditions. The company also said that any causal association between sitagliptin and pancreatitis is difficult to assess with the postmarketing reports because of incompleteness of the reports and other serious concurrent conditions in some of the patients. Based on a qualitative assessment of the reports, Merck voluntarily added pancreatitis to the postmarketing adverse events section of the labeling for both products earlier this year as a reported adverse event.
The FDA cautioned health care providers to be aware of the signs and symptoms of pancreatitis, which include nausea, vomiting, anorexia and persistent severe abdominal pain which can radiate to the back. The agency also suggested health care providers inform patients of these symptoms, so they are able to notify health care professionals if they occur.
Patients suspected of having pancreatitis should be monitored closely with the appropriate laboratory studies, such as serum and urine amylase, amylase/creatinine clearance ratio, electrolytes, serum calcium, glucose and lipase.
“Patients with type 2 diabetes are more likely to develop pancreatitis than other people, and as FDA noted in a publication earlier this year, 'diagnosis [of drug-induced pancreatitis] poses a challenge since it can be difficult to rule out other causes.' Merck would encourage any patient with concerns to speak with their physician,” Amatruda said in the release.
