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Arterial aneurysm and dissection with systemic vascular endothelial growth factor inhibitors: A review of cases reported to the FDA Adverse Event Reporting System and published in the literature by Connie Cheng; Michelle Nadeau Nguyen; Afrouz Nayernama; S Christopher Jones; Michael Brave; Sundeep Agrawal; Laleh Amiri-Kordestani; Daniel Woronow is a Medicine article available to read on EtoBox.

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The US Food and Drug Administration (FDA) has approved multiple systemic vascular endothelial growth factor (VEGF) inhibitors since 2004 to treat various malignancies. Inhibition of the VEGF signaling pathway can result in impairment of vascular wall integrity through medial degeneration and endothelial dysfunction, potentially resulting in arterial (including aortic) aneurysm/dissection. We performed a postmarketing review to evaluate arterial aneurysm/dissection as a potential safety risk for patients with cancer treated with VEGF inhibitors. We searched the FDA Adverse Event Reporting System (FAERS) database and literature for reports of arterial (including aortic) aneurysm/dissection with VEGF inhibitors currently approved by the FDA for a cancer indication. We identified 240 cases of arterial aneurysm/ dissection associated with VEGF inhibitors. The median time to onset of an arterial aneurysm/dissection event from the initiation of a VEGF inhibitor was 94 days (range 1-1955 days). Notably, 22% (53/240) of cases reported fatal outcomes related to arterial aneurysm/dissection. We determined the drug-event association as probable in 15 cases that lacked relevant confounding fact

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Author

Connie Cheng; Michelle Nadeau Nguyen; Afrouz Nayernama; S Christopher Jones; Michael Brave; Sundeep Agrawal; Laleh Amiri-Kordestani; Daniel Woronow

Publisher

SAGE Publications

Published

2021

Language

EN

Field

Medicine (Health Sciences)