Overview of the Safety of Anti-VEGF Drugs: Analysis of the Italian Spontaneous Reporting System

Paola Maria Cutroneo (), Claudia Giardina, Valentina Ientile, Simona Potenza, Laura Sottosanti, Carmen Ferrajolo, Costantino J. Trombetta and Gianluca Trifirò
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Paola Maria Cutroneo: Sicilian Regional Pharmacovigilance Center
Claudia Giardina: University Hospital G. Martino
Valentina Ientile: University Hospital G. Martino
Simona Potenza: Italian Medicines Agency
Laura Sottosanti: Italian Medicines Agency
Carmen Ferrajolo: University of Campania
Costantino J. Trombetta: University of Messina
Gianluca Trifirò: University Hospital G. Martino

Drug Safety, 2017, vol. 40, issue 11, No 8, 1140 pages

Abstract: Abstract Introduction Anti-vascular endothelial growth factor (anti-VEGF) drugs are widely used for the treatment of several cancers and retinal diseases. The systemic use of anti-VEGF drugs has been associated with an increased risk of serious adverse reactions. Whether this risk is also related to intravitreal administration of anti-VEGF drugs is unclear. Objective The aim of this study was to provide an overview of the safety of anti-VEGF drugs in oncology and ophthalmology settings using the Italian Spontaneous Reporting System (SRS). Methods We selected all suspected adverse drug reaction (ADR) reports attributed to anti-VEGF drugs and conducted descriptive frequency analyses stratified by indication of use. As a measure of disproportionality, we calculated the proportional reporting ratio with 95% confidence intervals at the level of standardized Medical Dictionary for Regulatory Activities (MedDRA®) queries (SMQs). Results Of a total of 2472 anti-VEGF drug-related reports, 2173 (87.9%) and 299 (12.1%) were attributed to systemic and intravitreal use of these drugs, respectively. The frequency of serious ADRs reported was higher for intravitreal administration of anti-VEGF drugs than for systemic use in patients with cancer (58.9 vs. 34.1%) (p

Date: 2017
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DOI: 10.1007/s40264-017-0553-y

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