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Approved by the Food and Drug Administration (FDA) in October 2006, Januvia® (generically sitagliptin) is a type-2 diabetes medication classified as a DDP-4 (dipeptidyl peptidase-4). It improves the body's ability to lower high blood sugar (glucose) levels.

Januvia® works by increasing the body's levels of a hormone called incretin, which can trigger increases in blood insulin levels, particularly after eating. Januvia® is produced and marketed by Merck & Co., and when the formulation contains another diabetes drug (metformin) for overweight or obese patients, it is sold by Merck under the brand name Janumet®. Januvia® is not indicated for type-1 diabetes patients.

Januvia® Uses and Indications

Januvia® (sitagliptin) is an oral medication that is typically taken once daily with or without food. Like other type-2 diabetes medications, Januvia® should be used in combination with eating a healthy diet and exercising regularly.

Patients should always disclose their complete medical history with their physician before starting a course of this diabetes medication. While beginning and taking a course of Januvia®, patients are strongly encouraged to regularly check their blood glucose levels and to report any abnormalities to their doctors, as this may be an indication that their dose needs to be adjusted.

Januvia® FDA Warnings

On Sept. 25, 2009, the FDA announced that was ordering Merck to revise the medication information on Januvia®'s packaging and advertising following 88 patient reports regarding the development of acute pancreatitis following use of Januvia®.

Acute pancreatitis is a severe, sudden swelling of the pancreas that is life-threatening and requires emergency medical treatment. The revision to Januvia® information was to include a warning regarding the reports of acute pancreatitis already received by the FDA while also pointing out that further research needed to be conducted to further evaluate the potential serious side effects of Januvia®.

Following the FDA warning, the agency also mandated that Merck conduct a three-month post-market safety study on the side effects of Januvia®. The study was supposed to be completed as of March 2011, with the final report presenting the study's results submitted to the FDA in June 2011. The FDA sent another letter to the company in February 2012 requiring it to submit a plan for the study to the FDA within 30 days and to conduct the study within 6 months of the date of the letter.

A separate, independent study conducted at UCLA found a possible connection between use of Januvia® and pancreatic cancer development. Specifically, the study found that patients taking Januvia® were six times more likely to develop pancreatitis and nearly three times more likely to be diagnosed with pancreatic cancer (as opposed to patients taking other diabetes medications).

Talk to a Januvia® Attorney Today

If you or a loved one has suffered from any severe Januvia® side effects, we encourage you to learn more about your legal rights and entitlements. Our skilled, experienced lawyers offer initial consults for free, and they will aggressively defend your rights in litigation, mediation or arbitration. To learn more, please contact our Januvia® lawyers today.