As Analysis Did Not Reveal Causes Of The Increase In Death Incidents, FDA Asks Its Advisory Committee To Discuss This Safety Issue At April 2015 Meeting
SUMMARY: The AstraZeneca diabetes drugs Onglyza (saxagliptin) and Kombiglyze (saxagliptin plus metformin) will come under scrutiny at an April 14, 2015 FDA meeting according to early news reports about that upcoming event.
As regards what the FDA Briefing Material document for this Kombiglyze / Onglyza safety meeting contained and its significance, from an April 10, 2015 Bloomberg news report, “AstraZeneca’s Diabetes Drug May Raise Death Risk, FDA Says”:
AstraZeneca Plc’s type 2 diabetes drug Onglyza showed an increased risk of death in an analysis by U.S. regulators of a clinical trial on the heart effects of the treatment. Food and Drug Administration staff said their analysis of deaths in the trial suggested patients using Onglyza experienced “significant or near-significant” increases in death from all causes, not just heart problems.
We will be watching for any significant developments coming out of this April 2015 FDA Advisory Committee Meeting concerning the safety of Onglyza and Kombiglyze such as a possible label change for these AstraZeneca diabetes drugs.[Read this article in full at original source]
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