Xolair Archives | Law Offices Of Thomas J. Lamb

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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Since FDA Early Communication About An Ongoing Safety Review Of Xolair Was Issued In 2009, The Agency Has Been Examining Xolair Safety Profile But FDA Is Still Unsure If This Drug Is Safe Or Not

SUMMARY: From this document issued in September 2014, “FDA Drug Safety Communication: FDA approves label changes for asthma drug Xolair (omalizumab), including describing slightly higher risk of heart and brain adverse events”, we get the latest news on the Xolair drug safety issue.

It was back in July 2009, when the FDA issued its Early Communication about an Ongoing Safety Review of Omalizumab (marketed as Xolair), that the agency first started reviewing interim safety findings from a study of the asthma drug omalizumab (Xolair) which suggested that the medication may be associated with increased risk for ischemic heart disease, arrhythmias, cardiomyopathy, cardiac failure, pulmonary hypertension, cerebrovascular disorders, and thromboembolic and thrombophlebitic events.

[Read this article in full at original source]

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Xolair Is Associated With Higher Than Expected Reporting Of Arterial Thrombotic Events Such As Strokes And Cardiovascular Deaths

While European Drug Regulators Have Been Concerned About This Aspect Of Xolair Safety, FDA Has No Warning About Arteriothrombotic Risks Of Xolair

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Xolair Asthma Drug Associated With Higher Rate Of Heart Attacks, Pulmonary Hypertension, Blood Clots Causing PEs And/Or DVTs, And Brain Blood Vessel Problems

Since FDA Early Communication About An Ongoing Safety Review Of Xolair Was Issued In 2009, The Agency Has Been Examining Xolair Safety Profile But FDA Is Still Unsure If This Drug Is Safe Or Not

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