Januvia Pancreatitis Risk Not Adequately Studied by Merck: FDA

According to federal drug regulators, Merck failed to conduct requested testing on their popular diabetes drugs Januvia and Janumet, which was designed to review the potential impact of the medications on the pancreas and assess the risk of pancreatis from Januvia and Janumet.

The FDA issued a warning letter to Merck on February 17, which was released by the agency this week.

In the letter, the FDA indicates that Merck failed to comply with proper testing for Januvia and Janumet, meaning that the drugs are now considered misbranded.

At issue are clinical trials that Merck should have performed on rats, but the FDA says that the company has not completed. Merck promised to conduct the three-month pancreatic safety study when the FDA expanded approvals for Januvia and Janumet.

Merck agreed to have a final protocol for the studies to the FDA by June 14, 2010. The study was supposed to be complete by March 15, 2011, and a final report should have been to the FDA by June 15, 2011.

The letter orders Merck to submit a plan for the study to the FDA within 30 days of the warning letter’s issuance. The trial has to start within six months of the agency’s approval of the plan.

Januvia (sitagliptin) is a medication approved for the treatment of adults with Type-2 diabetes. It is one of the first in a new class of medications known as dipeptidyl peptidase-4 (DPP-4) inhibitors, and it has rapidly become a strong selling medication for Merck. Janumet combines Januvia with metaformin.

The FDA made the requirements following increasing concerns over a Januvia pancreatitis risk, which surfaced nearly three years ago.

In September 2009, FDA recommended that doctors monitor patients carefully for signs of pancreatitis from Januvia and Janumet after starting treatment or increasing dosage. The agency found that in 58 of the 88 cases of pancreatitis Januvia and Janumet users required hospitalization, and four required treatment in intensive care units (ICU).

A 2011 Januvia pancreatic cancer study also found indications that the drug may increase the risk of pancreatitis and pancreatic cancer.