While European Drug Regulators Have Been Concerned About This Aspect Of Xolair Safety, FDA Has No Warning About Arteriothrombotic Risks Of Xolair
SUMMARY: In this post we consider a medical journal article which suggests that Xolair is associated with an increased risk of arterial thrombotic events, predominantly cardiovascular deaths and strokes.
The subject article is “Assessing the association between omalizumab and arteriothrombotic events through spontaneous adverse event reporting”, initially published online by the Journal of Asthma and Allergy back in May 2012.
According to the authors, their study is the first pharmacovigilance analysis to detect from a spontaneous event reporting database such as the FDA AERS a strong safety signal for Xolair as regards cardiovascular death and stroke events.
Numerous times throughout their article the authors acknowledge the limitations of their research methods and state that epidemiological studies are necessary to further explore the apparent association of Xolair with cardiovascular deaths, strokes, and other arterial thrombotic adverse events.[Read this article in full at original source]
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