Merck warned for not carrying out post-approval sitagliptin study

For some time the FDA has been warning drugmakers that it will tighten up its oversight of post-marketing commitments, after studies a few years ago indicated that two thirds of these studies were never carried out.

A final report on the issue released in March 2010 found that many postmarketing requirements (PMRs) and postmarketing commitments (PMCs) remained outstanding, although the picture was not quite so bad as thought earlier, with 31% fulfilled,  24% submitted and 10% ongoing. That still left 17% delayed, and a sizeable portion of the outstanding PMRs and PMCs were found to have no fixed completion dates.

Merck committed to carrying out a three-month pancreatic safety study in a rodent model of diabetes exposed to sitagliptin, after the FDA expressed concern about a risk of acute pancreatitis in some patients taking the drug in clinical trials.