Clinical Ophthalmology (2021-02-01)

Active Pharmacovigilance in Peruvian Population: Surveillance of a Timolol/Brimonidine/Dorzolamide Ophthalmic Fixed Combination

  • Contreras-Salinas H,
  • Barajas-Hernández M,
  • Baiza-Durán LM,
  • Vázquez-Álvarez AO,
  • Bautista-Castro MA,
  • Rodríguez-Herrera LY

Journal volume & issue
Vol. Volume 15
pp. 583 – 590


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Homero Contreras-Salinas,1 Mariana Barajas-Hernández,1 Leopoldo Martín Baiza-Durán,1 Alan Omar Vázquez-Álvarez,2 Manuel Alejandro Bautista-Castro,1 Lourdes Yolotzin Rodríguez-Herrera1 1Pharmacovigilance Department, Laboratorios Sophia, S.A. de C.V, Zapopan, Jalisco, México; 2School of Medicine and Health Science, Tecnológico de Monterrey, Guadalajara, Jalisco, MéxicoCorrespondence: Lourdes Yolotzin Rodríguez-Herrera Tel +52 3001 4200 ext 1188Email [email protected]: In this study active pharmacovigilance was used in an uncontrolled population to enrich the safety profile and canvass the Adverse Drug Reactions (ADRs) associated with the use of a fixed combination of 0.5% timolol + 0.2% brimonidine + 2.0% dorzolamide (TBD).Methods: Active pharmacovigilance consisting of 3 follow-up calls within 60 days was used to monitor the product’s safety and identify new risks by searching for unexpected ADRs and increased incidence, tolerability, drug interactions and special population-related ADRs.Results: Ninety-four ADRs were reported by a total of 246 patients (0.38 ADRs/patient); all of them were classified as “mild”. We found an increased risk of ADRs with a Relative Risk (RR) for simultaneous use of TBD + ophthalmic ciprofloxacin and TBD + oral atorvastatin; 2.0309 (95% CI, 1.2467– 3.3083) and 1.8864 (95% CI, 1.0543– 3.3754), respectively. Two unexpected ADRs were discovered, both of which presented belonged to the System Organ Class (SOC) of “infections and infestations” and the preferred term (PT) of “nasopharyngitis.”.Conclusion: Three safety signals were identified, two of them corresponded to an increase in the incidence of ADRs and the last one is associated with 2 unexpected ADR. Nevertheless, we found a good tolerability profile for TBD in the study population.Keywords: adverse drug reactions, active pharmacovigilance, surveillance, glaucoma, timolol/brimonidine/dorzolamide