Patients treated with Januvia
must be monitored
The FDA says physicians who prescribe Januvia to help Type 2 diabetes patients maintain good blood sugar level should closely monitor them for signs of pancreatic problems.
An analysis of insurance records shows that the use of Januvia could double the risk of developing acute pancreatitis. Patients should be aware that nausea, vomiting, anorexia and abdominal pain can be signs of pancreatitis and should report symptoms to their doctor immediately.
The FDA set in place these precautions after 88 cases of acute pancreatitis were reported to the agency’s Adverse Event Reporting System (AERS) between October 2006 and February 2009.
Analysis revealed that in 21 percent of cases, pancreatitis symptoms occurred within 30 days of starting Januvia. Furthermore, 47 of the 88 cases, or 53 percent, resolved after patients quit taking the medicine.
Januvia belongs to a class of drugs called incretin mimetics, which the FDA is investigating as a possible risk factor for increased risk of pancreatitis and pre-cancerous cellular changes. Incretin mimetics are used along with other drugs, healthier diet, and more exercise to help patients with Type 2 diabetes achieve optimum blood sugar levels.