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

• Main Authors: Contreras-Salinas H, Barajas-Hernández M, Baiza-Durán LM, Vázquez-Álvarez AO, Bautista-Castro MA, Rodríguez-Herrera LY
• Format: Article
• Language: English
• Published: Dove Medical Press 2021-02-01
• Series: Clinical Ophthalmology
• Subjects: adverse drug reactions; active pharmacovigilance; surveillance; glaucoma; timolol/brimonidine/dorzolamide.
• Online Access: https://www.dovepress.com/active-pharmacovigilance-in-peruvian-population-surveillance-of-a-timo-peer-reviewed-article-OPTH

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 [phone] ext 1188Email [e-mail]: 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