Could Januvia Side Effects Migrate to Janumet?

Washington, DCAn effort by the manufacturer of Januvia to expand the use of the active ingredient of sitagliptin is being undertaken at the same time as a study by the US Food and Drug Administration (FDA) that hopes to further identify risks in the class of Januvia drugs to which Januvia belongs.

According to the January 17 issue of the Washington Drug Letter (WDL), the FDA hopes to have a mini-Sentinel study completed by March that could prompt labeling changes for Onglyza—which is co-marketed by Bristol-Meyers Squibb and AstraZeneca—or all the drugs in its class.

That class, known as DPP-4 inhibitors, includes Merck's Januvia. Rachel Behrman, director of The Center for Drug Evaluation and Research (CDER) Office of Medical Policy, said that if data are sufficiently compelling and the FDA believes it needs to change labeling, "we will do so.

"If there is a class effect, we will initiate class labeling changes," she added. Behrman made the comments at the third annual Sentinel Initiative public workshop in Washington, DC.

Mini-Sentinel is a pilot project to facilitate development of the Sentinel System as an active surveillance system to monitor the safety of FDA-regulated medical products.

A randomized Onglyza trial compares new users of the drug with those of four other comparator drugs, including the Januvia diabetes drug. The primary endpoint for the study is acute myocardial infarction and a secondary endpoint is acute coronary syndrome.

While all this is going on, Merck has received FDA acceptance of a New Drug Application that applies to an extended-release version of Janumet. The latter is the combination of sitagliptin (Januvia) and extended-release metformin. Janumet is already on the market and available as a single-release only.

The extended-release version would be a boon to patients who require two or more oral agents for the control of blood sugar, but would prefer the convenience of once daily dosing.

It should be noted that the FDA, in 2009, mandated a revision of the Januvia label to include the possibility of Januvia pancreatitis and Januvia cancer. At the same time, closeupmedia.com notes in the January 17 issue of Health & Beauty Close-Up that Janumet has not been studied in patients with a history of pancreatitis.

With the potential for an expanded mandate for Janumet—and, by default Januvia since sitagliptin is an active ingredient—one wonders as to Januvia side effects that may migrate over to the Janumet side through its expanded use.