Onglyza News: FDA Issues New Diabetes Drug Warning
The U.S. Food & Drug Administration (FDA) has issued a new alert pertaining to Onglyza and other dipeptidyl peptidase-4 (DPP-4) inhibitors, after the Type 2 diabetes medications were linked to severe and disabling joint pain. The joint pain alert was issued even as the agency works to complete its ongoing review of Onglyza and heart failure.
According to the FDA, at least 33 people taking DPP-4 inhibitors have experienced severe joint pain, including five Onglyza patients. 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. + A new Warning and Precaution regarding the potential for joint pain has been added to the labels of Onglyza and other DPP-4 inhibitors.
“Contact your health care professional right away if you develop severe and persistent joint pain while taking one of these medicines,” the FDA said. “Do not stop taking your DPP-4 inhibitor medicine without first talking to your health care professional.”
Onglyza Heart Failure Review
Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin and metformin HCl extended-release) are intended to be used in conjunction with diet and exercise to control Type 2 diabetes. In April, a panel of FDA advisors recommended that the drugs’ labels be updated to include information about a possible increased risk of heart failure and death, after a clinical trial suggested that saxagliptin was associated with a 27% increased risk of hospitalization for heart failure. FDA staffers also identified an increase in the rate of “all-cause mortality” among the Onglyza patients in that trial.
The 15-member FDA advisory panel voted to recommend the label changes by a vote of 14 to 1. While the FDA is not required to follow the advice of its panels, it usually does so.
Onglyza Lawsuit Reviews
Bernstein Liebhard LLP is now offering free legal reviews to alleged victims of Onglyza heart failure. If you or a loved one were hospitalized with this condition while using Onglyza, please call 1-877-779-1414 to learn more.