Active Pharmacovigilance in Peruvian Population: Surveillance of a Timolol/Brimonidine/Dorzolamide Ophthalmic Fixed Combination
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...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2021-02-01
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| Series: | Clinical Ophthalmology |
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| Online Access: | https://www.dovepress.com/active-pharmacovigilance-in-peruvian-population-surveillance-of-a-timo-peer-reviewed-article-OPTH |
| _version_ | 1818981487059402752 |
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| author | Contreras-Salinas H Barajas-Hernández M Baiza-Durán LM Vázquez-Álvarez AO Bautista-Castro MA Rodríguez-Herrera LY |
| author_facet | Contreras-Salinas H Barajas-Hernández M Baiza-Durán LM Vázquez-Álvarez AO Bautista-Castro MA Rodríguez-Herrera LY |
| author_sort | Contreras-Salinas H |
| collection | DOAJ |
| description | 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 lourdes.rodriguez@sophia.com.mxPurpose: 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 |
| first_indexed | 2024-12-20T17:32:06Z |
| format | Article |
| id | doaj.art-0461246abb8d42d18a83b40487dc3999 |
| institution | Directory Open Access Journal |
| issn | 1177-5483 |
| language | English |
| last_indexed | 2024-12-20T17:32:06Z |
| publishDate | 2021-02-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Clinical Ophthalmology |
| spelling | doaj.art-0461246abb8d42d18a83b40487dc39992022-12-21T19:31:20ZengDove Medical PressClinical Ophthalmology1177-54832021-02-01Volume 1558359062170Active Pharmacovigilance in Peruvian Population: Surveillance of a Timolol/Brimonidine/Dorzolamide Ophthalmic Fixed CombinationContreras-Salinas HBarajas-Hernández MBaiza-Durán LMVázquez-Álvarez AOBautista-Castro MARodríguez-Herrera LYHomero 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 lourdes.rodriguez@sophia.com.mxPurpose: 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/dorzolamidehttps://www.dovepress.com/active-pharmacovigilance-in-peruvian-population-surveillance-of-a-timo-peer-reviewed-article-OPTHadverse drug reactionsactive pharmacovigilancesurveillanceglaucomatimolol/brimonidine/dorzolamide. |
| spellingShingle | Contreras-Salinas H Barajas-Hernández M Baiza-Durán LM Vázquez-Álvarez AO Bautista-Castro MA Rodríguez-Herrera LY Active Pharmacovigilance in Peruvian Population: Surveillance of a Timolol/Brimonidine/Dorzolamide Ophthalmic Fixed Combination Clinical Ophthalmology adverse drug reactions active pharmacovigilance surveillance glaucoma timolol/brimonidine/dorzolamide. |
| title | Active Pharmacovigilance in Peruvian Population: Surveillance of a Timolol/Brimonidine/Dorzolamide Ophthalmic Fixed Combination |
| title_full | Active Pharmacovigilance in Peruvian Population: Surveillance of a Timolol/Brimonidine/Dorzolamide Ophthalmic Fixed Combination |
| title_fullStr | Active Pharmacovigilance in Peruvian Population: Surveillance of a Timolol/Brimonidine/Dorzolamide Ophthalmic Fixed Combination |
| title_full_unstemmed | Active Pharmacovigilance in Peruvian Population: Surveillance of a Timolol/Brimonidine/Dorzolamide Ophthalmic Fixed Combination |
| title_short | Active Pharmacovigilance in Peruvian Population: Surveillance of a Timolol/Brimonidine/Dorzolamide Ophthalmic Fixed Combination |
| title_sort | active pharmacovigilance in peruvian population surveillance of a timolol brimonidine dorzolamide ophthalmic fixed combination |
| topic | adverse drug reactions active pharmacovigilance surveillance glaucoma timolol/brimonidine/dorzolamide. |
| url | https://www.dovepress.com/active-pharmacovigilance-in-peruvian-population-surveillance-of-a-timo-peer-reviewed-article-OPTH |
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