Onglyza May Increase Death Rate According to FDA

By Rheingold Giuffra Ruffo & Plotkin LLP

According to a preliminary report by the Food and Drug Administration (FDA), Onglyza, AstraZeneca’s diabetes drug, could possibly be associated with an increased rate of death. The report, which was published on Friday, just a few days before an FDA advisory meeting, that will deliberate the safety of Onglyza, as well as Nesina, a similar drug produced by the Takeda Pharmaceutical Company.

Over 6 years ago, in December of 2008, the FDA required drug companies to study whether or not new diabetes drugs increase cardiovascular risk. Onglyza, known as saxagliptin, received FDA approval in 2009, and was required to complete the aforementioned studies.

SAVOR, a clinical trial of over 16,000 patients, indicated that patients taking Onglyza had an increased incidence of heart failure. After analyzing the study, the FDA concluded the study was valid, and found a potential increase in risk of death from the drug generally. Although many of the deaths were multifactorial, “a significantly increased risk of all-cause mortality” was found.

EXAMINE, a similar study testing Nesina, revealed no significant statistical difference in heart failure rates. Investigations of other drugs from the same class, DPP-4 inhibitors, are being done as well.

Related Posts