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Adverse drug reaction profile of oseltamivir in Indian population: A prospective observational study

OBJECTIVES: To analyze the pattern of adverse drug reactions (ADRs) of oseltamivir and its comparison with available data. MATERIALS AND METHODS: Suspected or confirmed cases of H1N1 influenza A on therapeutic regimen and close contacts of cases H1N1 influenza A on prophylactic regimen of oseltamivi...

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Autores principales: Anovadiya, Ashish P., Barvaliya, Manish J., Shah, Rajesh A., Ghori, Vishal M., Sanmukhani, Jayesh J., Patel, Tejas K., Tripathi, C. B.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3113375/
https://www.ncbi.nlm.nih.gov/pubmed/21713087
http://dx.doi.org/10.4103/0253-7613.81509
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author Anovadiya, Ashish P.
Barvaliya, Manish J.
Shah, Rajesh A.
Ghori, Vishal M.
Sanmukhani, Jayesh J.
Patel, Tejas K.
Tripathi, C. B.
author_facet Anovadiya, Ashish P.
Barvaliya, Manish J.
Shah, Rajesh A.
Ghori, Vishal M.
Sanmukhani, Jayesh J.
Patel, Tejas K.
Tripathi, C. B.
author_sort Anovadiya, Ashish P.
collection PubMed
description OBJECTIVES: To analyze the pattern of adverse drug reactions (ADRs) of oseltamivir and its comparison with available data. MATERIALS AND METHODS: Suspected or confirmed cases of H1N1 influenza A on therapeutic regimen and close contacts of cases H1N1 influenza A on prophylactic regimen of oseltamivir were included. Data were collected by personal interview after obtaining written informed consent. Causality, severity, and preventability assessments were done by using Naranjo's scale, modified Hartwig and Siegel's scale, and modified Schumock and Thornton Scale, respectively. Data were expressed in proportions. Frequency of ADRs in therapeutic and prophylactic groups were compared with phase III trial of oseltamivir by using Chi-square test. RESULTS: Total 294 patients were interviewed. In prophylactic group, 107 of 257 (41.63%) and in therapeutic, group 23 of 37 (62.16%) developed ADRs. ADRs reported in therapeutic group was significantly (P = 0.029) higher as compared with prophylactic group. Frequently observed ADRs in both the groups were gastritis, nausea, vomiting, diarrhea weakness, sedation, loneliness, sadness, headache, and abdominal pain. Naranjo's algorithm showed all ADRs in probable category in prophylactic group, 27.78% probable and 72.22% possible reactions in therapeutic group. Severity assessment showed 76% mild and 24% moderate reactions in therapeutic group, 89% mild and 11% moderate reactions in prophylactic group. Severity of ADRs was significantly higher in therapeutic group. Most of ADRs were in nonpreventable category, except gastritis, nausea and vomiting were in definitely preventable category. CONCLUSION: Oseltamivir is well tolerated in Indian population. Gastrointestinal side effects are most common and preventable.
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spelling pubmed-31133752011-06-27 Adverse drug reaction profile of oseltamivir in Indian population: A prospective observational study Anovadiya, Ashish P. Barvaliya, Manish J. Shah, Rajesh A. Ghori, Vishal M. Sanmukhani, Jayesh J. Patel, Tejas K. Tripathi, C. B. Indian J Pharmacol Research Article OBJECTIVES: To analyze the pattern of adverse drug reactions (ADRs) of oseltamivir and its comparison with available data. MATERIALS AND METHODS: Suspected or confirmed cases of H1N1 influenza A on therapeutic regimen and close contacts of cases H1N1 influenza A on prophylactic regimen of oseltamivir were included. Data were collected by personal interview after obtaining written informed consent. Causality, severity, and preventability assessments were done by using Naranjo's scale, modified Hartwig and Siegel's scale, and modified Schumock and Thornton Scale, respectively. Data were expressed in proportions. Frequency of ADRs in therapeutic and prophylactic groups were compared with phase III trial of oseltamivir by using Chi-square test. RESULTS: Total 294 patients were interviewed. In prophylactic group, 107 of 257 (41.63%) and in therapeutic, group 23 of 37 (62.16%) developed ADRs. ADRs reported in therapeutic group was significantly (P = 0.029) higher as compared with prophylactic group. Frequently observed ADRs in both the groups were gastritis, nausea, vomiting, diarrhea weakness, sedation, loneliness, sadness, headache, and abdominal pain. Naranjo's algorithm showed all ADRs in probable category in prophylactic group, 27.78% probable and 72.22% possible reactions in therapeutic group. Severity assessment showed 76% mild and 24% moderate reactions in therapeutic group, 89% mild and 11% moderate reactions in prophylactic group. Severity of ADRs was significantly higher in therapeutic group. Most of ADRs were in nonpreventable category, except gastritis, nausea and vomiting were in definitely preventable category. CONCLUSION: Oseltamivir is well tolerated in Indian population. Gastrointestinal side effects are most common and preventable. Medknow Publications 2011 /pmc/articles/PMC3113375/ /pubmed/21713087 http://dx.doi.org/10.4103/0253-7613.81509 Text en © Indian Journal of Pharmacology http://creativecommons.org/licenses/by-nc-sa/3.0 This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Anovadiya, Ashish P.
Barvaliya, Manish J.
Shah, Rajesh A.
Ghori, Vishal M.
Sanmukhani, Jayesh J.
Patel, Tejas K.
Tripathi, C. B.
Adverse drug reaction profile of oseltamivir in Indian population: A prospective observational study
title Adverse drug reaction profile of oseltamivir in Indian population: A prospective observational study
title_full Adverse drug reaction profile of oseltamivir in Indian population: A prospective observational study
title_fullStr Adverse drug reaction profile of oseltamivir in Indian population: A prospective observational study
title_full_unstemmed Adverse drug reaction profile of oseltamivir in Indian population: A prospective observational study
title_short Adverse drug reaction profile of oseltamivir in Indian population: A prospective observational study
title_sort adverse drug reaction profile of oseltamivir in indian population: a prospective observational study
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3113375/
https://www.ncbi.nlm.nih.gov/pubmed/21713087
http://dx.doi.org/10.4103/0253-7613.81509
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