FDA Adds Heart Failure Warning to Januvia and Janumet

By Jeemin Kwon

Despite neutral heart outcome study results, the FDA added a warning for those at risk of heart failure

Januvia, a once-daily pill for type 2 diabetes (a DPP-4 inhibitor), has a new warning label for increased risk of heart failure. Though a recent outcome study showed clearly that Januvia is no riskier for the heart, the FDA seems to be taking a conservative approach based on other studies of similar drugs.

The heart outcomes trial in question was called TECOS, which compared people taking Januvia, Janumet, or Janumet XR (sitagliptin) to people taking placebo. The study reported a neutral finding – the drugs in the Januvia family neither increased nor decreased instances of hospitalization for heart failure.

In contrast, Onglyza, another DPP-4 inhibitor with the same heart failure warning as Januvia now has, was associated with a 27% increase in heart failure hospitalizations in the SAVOR-TIMI heart outcome trial. The FDA has also included heart failure warnings for Nesina and Tradjenta, the other two FDA-approved DPP-4 inhibitors. The warning added to the Januvia label appears to be a “just-in-case” decision by the FDA, based on the studies of DPP-4 inhibitors other than Januvia.

It should be noted that the FDA warning label for Januvia and Janumet (which combines Januvia and metformin) cautions against prescribing these medications for people at risk for heart failure. What that means is for people without risk for heart failure, Januvia is considered a viable treatment option. (Major risk factors for heart failure include a history of heart attack, coronary artery disease, or high blood pressure.)

Januvia and other DPP-4 inhibitors are typically used early in the course of type 2 diabetes, as they bring low risk of hypoglycemia and few side effects.