Onglyza Side Effects: Bone Fracture Risk Dubbed “Neutral”

Published on September 18, 2015 by Sandy Liebhard

Text-Size:A A A+


Patients who rely on Onglyza to control Type 2 diabetes have one less safety issue to worry about. According to a newly-released study, Onglyza neither increases nor decreases the risk for bone fractures.

The study’s findings drew on data from the SAVOR-TMI trial, the same 16,492-patient study which recently linked Onglyza to heart failure. The trial’s subjects consisted of 8,280 patients randomly assigned 5mg of Onglyza daily and 8,212 controls assigned a placebo. While SAVOR-TMI was designed to investigate cardiovascular outcomes, researchers at Hadassah Hebrew University Hospital in Jerusalem also analyzed all participants’ fracture risk.

Of the patients taking Onglyza, 241 (2.9%) experienced a fracture during a median follow-up of 2.1 years; 240 adults in the placebo group (2.9%) also experienced a fracture. Both groups developed 14.7 fractures per 1,000 patient-years. After adjusting for race, cardiovascular risk and renal function, fracture risk remained similar in both patient groups.

“There was also no difference in major osteoporotic fracture as classified according to the [WHO] definition,” the researchers wrote. “Therefore … saxagliptin therapy does not influence the risk of fractures among patients with type 2 diabetes.”

Onglyza Heart Failure Review

While this study is good news, it’s important to note that Onglyza may still be associated with some serious safety risks. In April, a panel of advisors for the U.S. Food & Drug Administration (FDA) voted 14-1 to recommend that new safety information regarding an increased risk of heart failure be added to the Onglyza label. The FDA had launched a review of the drug in February 2014, after data from SAVOR-TMI indicated that Onglyza patient were 27% more likely to be hospitalized for heart failure compared to those taking a placebo.

Late last month, the FDA warned that Onglyza and other DPP-4 inhibitors might cause severe joint pain. There have also been concerns that Onglyza might increase a patient’s risk for acute pancreatitis and pancreatic cancer.

Bernstein Liebhard LLP is now investigating potential Onglyza lawsuits on behalf of individuals who were hospitalized with heart failure while taking this medication. To arrange for a free legal evaluation with one of our attorneys, please call .

Web Analytics