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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