Merck & Co., Inc., issued the following statement today in response to the U.S. Food and Drug Administration's (FDA's) update on JANUVIA (sitagliptin) and JANUMET (sitagliptin/metformin).
"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 post marketing adverse experience reports, and Merck believes these data do not demonstrate that a causal relationship exists between sitagliptin and pancreatitis. Merck appreciates the important role that the FDA plays in assessing the safety of medicines and, as we do with all of our medicines, we will continue to monitor the safety of JANUVIA and will share the data with regulatory agencies and the medical community," said John Amatruda, M.D., Senior Vice President and Franchise Head, Diabetes and Obesity, Merck Research Laboratories. "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."
There have been reports of pancreatitis following use of many other prescription medications and non-prescription medications, including other type 2 diabetes prescription medications.
JANUVIA is indicated, as an adjunct to diet and exercise, to improve glycemic control in adult patients with type 2 diabetes. JANUMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate. JANUMET and JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. JANUMET and JANUVIA have not been studied in combination with insulin.
Merck carefully monitors post marketing reports for all of our medicines, including JANUVIA and JANUMET, and updates the label as appropriate. Post-marketing events are reported voluntarily from a population of uncertain size, and it is generally not possible to reliably establish the frequency of such events or establish a causal relationship between a medicine and a specific adverse event.