Merck has carefully reviewed the reports of pancreatitis in the post-marketing database, including the reports of more serious cases. In our review, the reports showed that the more serious cases also had other serious medical conditions. As is often the case with post-marketing reports, any causal association between sitagliptin and pancreatitis is difficult to assess due to such factors as the 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 post-marketing adverse events section of the labeling for JANUVIA and JANUMET earlier this year as a reported adverse event to make physicians aware of these reports.

The safety profile of JANUVIA and JANUMET has been established through an extensive clinical development program. In addition, in the nearly three years of marketed use, more than 18 million total prescriptions have been dispensed for sitagliptin worldwide.

Merck has published a peer-reviewed analysis of safety data pooled from twelve Phase IIb/III trials in 6,139 patients studied for up to two years in our clinical development program, in which the incidence rates of pancreatitis (0.1% sitagliptin vs. 0% non-exposed), acute pancreatitis (0% vs. 0.1%), and chronic pancreatitis (0.1% vs. 0%) reported in patients treated with sitagliptin were not meaningfully different from that in patients not exposed to sitagliptin.

Merck will continue communicating with patients and healthcare providers about JANUVIA and JANUMET in ways that will help inform their decisions about appropriate treatment choices. Patients should talk with their healthcare providers if they have any questions, and before starting or stopping treatment with any prescription medicine.

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