Since 2014, Onglyza and Kombliglyze XR have been the subject of a U.S. Food & Drug Administration (FDA) safety review to determine wether or not patients using the Type 2 medications are more likely to be hospitalized for heart failure. The review was launched after a study published in the New England Journal of Medicine suggested a potential link between Onglyza and heart failure.
Heart failure is an extremely serious complication, and can be physically, emotionally and financially devastating to patients and their families. If you or loved one were harmed by either of these diabetes medications, filing an Onglyza heart failure lawsuit could allow you to obtain compensation to cover your injury-related damages, including medical bills, lost wages, pain and suffering, and more. If you would like to learn more about pursuing such a claim, please contact the nationwide law firm of Bernstein Liebhard LLP today. Our attorneys can evaluate your case for free, and help you determine if filing an Onglyza lawsuit is in your best interest.
Onglyza and Kombliglyze XR are both part of the incretin mimetics diabetes drug class, and both contain the active ingredient saxaglipitin. Early clinical trials of saxagliptin did suggest that the medication might be associated with increased cardiovascular risks, including heart failure. In October 2013, data from the SAVOR-TIMI 53 published in The New England Journal of Medicine suggested that patients treated with saxagliptin were 27% more likely to be hospitalized for heart failure compared to those treated with a placebo. The study, which included 16,492 diabetic patients, did not indicate an increased risk of heart attack, stroke, or death.
In February 2014, the FDA announced it had launched a safety review of both medications, and asked the manufacturers of Onglyza and Kombliglyze XR for raw data from the SAVOR trial. In April 2015, the FDA convened a group of medical advisors to review the cardiovascular risks associated with the two drugs, with the panel recommending by an overwhelming vote to modify the labels for Onglyza and Kombliglyze XR with information about their possible association with heart failure.
Congestive heart failure occurs when the heart is too weak to pump blood, which deprives the body’s cells of oxygen and nutrients they need to survive. As this progressive condition worsens, the heart muscle thickens and ultimately grows weaker, making normal daily activities extremely difficult.
Typical heart failure symptoms include:
Bernstein Liebhard LLP represents individuals harmed by defective drugs and other medical products, and our attorneys are currently offering free, no-obligation legal reviews to alleged victims of Onglyza heart failure. To learn more about your legal options, please call .