Onlyza, a medication that was recently the subject of heart failure warnings, doesn’t appear to be delivering for  AstraZeneca PLC.  According to the company’s latest earnings report, sales of the Type 2 diabetes medication were down a staggering 22% during the final quarter of 2016.

Onglyza’s dismal sales aren’t that surprising. Safety concerns  prompted Express Scripts, the nation’s largest pharmacy benefits manager, to remove Onglyza and Kombiglyze XR from its 2016 formulary. The two medications were also excluded from the formulary this year.

FDA Onglyza Warnings

Onglyza and Kombiglyze XR belong to a class of Type 2 diabetes medications called DPP-4 inhibitors. Onglyza contains saxagliptin as its active ingredient, while Kombiglyze XR contains both saxagliptin and metformin.

In April 2015, a U.S. Food & Drug Administration (FDA) advisory panel recommended that the drugs’ labels be updated to include information about a potential risk of heart failure, after a clinical trial indicated that patients exposed to saxagliptin were 27% more likely to be hospitalized for heart failure compared to those taking a placebo.  According to, labels for several DPP -4 inhibitors, including Onglyza and Kombiglyze XR, were updated nearly a year later with information regarding a potential link to heart failure.

“Health care professionals should consider discontinuing medications containing saxagliptin and alogliptin in patients who develop heart failure and monitor their diabetes control,” the FDA  said. “If a patient’s blood sugar level is not well-controlled with their current treatment, other diabetes medicines may be required.”

In August 2015, the labels for Onglyza and other DPP-4 inhibitors were updated to include warnings regarding a potential for disabling joint pain. At the time, the FDA reported that at least 33 people taking the drugs had experienced severe joint pain, including five who were being treated with Onglyza. Symptoms commenced from 1 day to years after the affected individuals started taking a DPP-4 inhibitor, and most experienced relief in less than a month once the medication was stopped. Some patients experienced a recurrence of joint pain when treatment resumed, either with the same drug or another DPP-4 inhibitor.

Onglyza Lawsuit Reviews

Bernstein Liebhard LLP offers free legal reviews to individuals who were hospitalized for heart failure  while using Onglyza or Kombiglyze XR. To learn more about filing an Onglyza lawsuit, please call 1-877-779-1414.

Published February 21, 2017 by