Ophthalmic Solution Safety Profile: Active Surveillance of a Sodium Hyaluronate/Chondroitin Sulfate Combination in Peruvian Population
| Autor: | Lourdes Yolotzin Rodríguez-Herrera, Homero Contreras-Salinas, Leopoldo Martín Baiza-Durán, Mariana Barajas-Hernández, Vanessa Orozco-Ceja |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Sodium hyaluronate Population adverse drug reaction Drug Healthcare and Patient Safety Postmarketing surveillance 030226 pharmacology & pharmacy artificial tears 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Internal medicine Pharmacovigilance post-marketing surveillance medicine education Original Research Pharmacology education.field_of_study business.industry 030503 health policy & services Health Policy medicine.disease dry eye disease Tolerability chemistry Population study Eye disorder 0305 other medical science business Adverse drug reaction |
| Zdroj: | Drug, Healthcare and Patient Safety |
| ISSN: | 1179-1365 |
| Popis: | Homero Contreras-Salinas, Mariana Barajas-Hernández, Leopoldo Martín Baiza-Durán, Vanessa Orozco-Ceja, Lourdes Yolotzin Rodríguez-Herrera Pharmacovigilance Department, Laboratorios Sophia, S.A. de C.V., Guadalajara, Jalisco, MexicoCorrespondence: Lourdes Yolotzin Rodríguez-Herrera Tel +52 33 3001 4200 Ext 1188Email lourdes.rodriguez@sophia.com.mxBackground: Sodium hyaluronate/chondroitin sulfate fixed combination plays an essential role in the treatment of keratoconjunctivitis sicca, a multifactorial disease accompanied by ocular symptoms like alteration of the tear film. Despite low or no absorption of such drugs, these can cause secondary effects. An essential tool in the study of medication behavior is active pharmacovigilance. Unlike spontaneous reporting pharmacovigilance, this tool allows an appraisal of adverse drug reactions (ADRs)’ real incidence, a higher capacity to identify safety signals, the relationship with concomitant drugs and pathologies prevalent in the study population. This study aimed to evaluate the safety profile and identify and/or assess adverse reactions in an uncontrolled population.Methods: Active pharmacovigilance by Drug Event Monitoring was performed. A total of 3 follow-up calls were made for 30 days for the identification of the ADRs, tolerability (ADR severity, seriousness, long term sequelae, and duration) and the possible risks (safety signals, medical interactions) of sodium hyaluronate and chondroitin sulfate (HUM).Results: Thirty-five ADRs were identified in the 212 patients included in the study (0.17 ADR/patient). The 35 ADRs were classified into 3 System Organ Class (SOC) groups: general disorders and administration site conditions (74.2%), eye disorders (22.9%), and nervous system disorders (2.9%); and 4 Preferred Term (PT) groups: burning sensation (74.2%), followed by blurred vision (20%), ocular pain (2.9%) and headache (2.9%). All the ADRs were categorized as mild and not serious. No statistically significant differences were found in concomitantly medications, posology and age groups.Conclusion: Good tolerability to the solution was identified, with a low incidence of ADRs. Just the same, all the associated ADRs were consistent with the information found in HUM’s physicochemical profile and the physiopathology of DED. No unknown risks were identified, reinforcing HUM’s safety profile.Keywords: post-marketing surveillance, adverse drug reaction, artificial tears, dry eye disease |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|