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

Author

Listed:
  • Paola Maria Cutroneo

    (Sicilian Regional Pharmacovigilance Center
    University Hospital G. Martino)

  • 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
    University of Messina)

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

Suggested Citation

  • Paola Maria Cutroneo & Claudia Giardina & Valentina Ientile & Simona Potenza & Laura Sottosanti & Carmen Ferrajolo & Costantino J. Trombetta & Gianluca Trifirò, 2017. "Overview of the Safety of Anti-VEGF Drugs: Analysis of the Italian Spontaneous Reporting System," Drug Safety, Springer, vol. 40(11), pages 1131-1140, November.
  • Handle: RePEc:spr:drugsa:v:40:y:2017:i:11:d:10.1007_s40264-017-0553-y
    DOI: 10.1007/s40264-017-0553-y
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