AstraZeneca Sponsored Study Conflicts with SAVOR Review by the FDA, which Indicated Potential 27% Increased Risk of Hospitalization from Heart Failure Among Onglyza Users
Alleged Side Effects of Onglyza
Onglyza (saxagliptin) is a popular diabetes medication developed jointly by AstraZeneca and Bristol-Myers Squibb, and is prescribed to help control blood sugar levels in adults with Type 2 diabetes. Approved by the FDA in July 2009, Onglyza belongs to a class of diabetes drugs called incretin mimetics, which work by mimicking the functions of the natural incretin hormones in the body that help lower post-meal blood sugar levels. Onglyza falls into the category of incretin mimetic diabetes drugs called dipeptidyl peptidase 4 (DPP-4) inhibitors, which means the prescription medication blocks DPP-4, a protein that increases blood glucose levels.
AstraZeneca Questions Onglyza Heart Failure Risk
At a meeting of the American Diabetes Association (ADA) in June, Onglyza maker AstraZeneca presented data suggesting that there is no evidence linking the use of Onglyza to an increased risk of hospitalization from heart failure. This Onglyza report submitted by AstraZeneca is a review of data from an observational, retrospective insurance claims database study, and the findings contradict a growing number of studies published in recent years, which have indicated that Onglyza users may face an increased risk of severe side effects from the diabetes drug, including heart failure, pancreatitis, pancreatic cancer and thyroid cancer.
FDA Requires Stronger Onglyza Warnings
In light of this alleged Onglyza side effect risk, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 in April, to require stronger warnings on the Onglyza label, regarding the higher-than-expected risk of hospitalization and all-cause mortality among patients using the Type 2 diabetes drug. In spite of these FDA recommendations, AstraZeneca is now claiming that its new analysis of the SAVOR clinical trial, which involved 16,492 patients with Type 2 diabetes prescribed Onglyza or a placebo, suggests that Onglyza and another diabetes drug called Januvia were associated with lower risks of hospitalization for heart failure than another class of diabetes drugs known as sulfonylureas.
A Qualified Onglyza Lawyer Can Help
AstraZeneca’s new report is in direct conflict with a previous SAVOR review by the FDA, which indicated that the clinical trial results showed a potential 27% increased risk of hospitalization from heart failure among Onglyza users. The FDA review of the SAVOR clinical trial results also found an increased risk of cardiovascular death and death from all causes associated with Onglyza. If you believe you have been adversely affected by side effects of Onglyza, such as heart failure or pancreatic cancer, contact a reputable Onglyza attorney today to discuss your possible compensation options.