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. 2024 Jan-Dec:61:469580241273323.
doi: 10.1177/00469580241273323.

Adverse Drug Reactions Resulting From the Use of Chiral Medicines Amoxicillin, Amoxicillin-Clavulanic Acid, and Ceftriaxone: A Mixed Prospective-Retrospective Cohort Study

Kissa W Mwamwitwa  1   2 , Elias M Bukundi  1 , Betty A Maganda  1 , Castory Munishi  1 , Adam M Fimbo  2 , Deus Buma  3 , Eva P Muro  4 , Wilber Sabiiti  5 , Danstan H Shewiyo  2 , Morven C Shearer  5 , Andrew D Smith  5 , Eliangiringa A Kaale  1
Affiliations

Adverse Drug Reactions Resulting From the Use of Chiral Medicines Amoxicillin, Amoxicillin-Clavulanic Acid, and Ceftriaxone: A Mixed Prospective-Retrospective Cohort Study

Kissa W Mwamwitwa et al. Inquiry. 2024 Jan-Dec.

Abstract

The use of chiral medicines (possessing center(s) of asymmetric carbon) may cause adverse drug reactions (ADRs). The safety assurance of these medicines is critical. We aimed to evaluate registered and commonly used anti-infective chiral medicines circulating in the Tanzanian market to establish their safety profile to protect public health. A mixed prospective-retrospective cohort study was conducted to assess the safety profile of amoxicillin, amoxicillin-clavulanic acid and ceftriaxone injection. ADRs causality assessment was conducted by using World Health Organization (WHO)-Algorithm criteria. Data were collected from 7 tertiary hospitals: Muhimbili National Hospital (MNH), Kilimanjaro Christian Medical Centre (KCMC), Bugando Medical Centre (BMC), Ligula Referral-Regional Hospital (LRRH), Kitete Referral-Regional Hospital (KRRH), Dodoma Referral-Regional Hospital (DRRH), and Mbeya Zonal-Referral Hospital (MZRH). Data were supplemented by those recorded in the WHO-Vigiflow/VigiLyze database within the same monitoring period. Data were analyzed using STATA version-15. The results were considered statistically significant when P < .05. A total of 2522 patients were enrolled in hospitals: MNH (499), KCMC (407), BMC (396), LRRH (387), KRRH (345), DRRH (249), and MZRH (239). Among those, 1197 (47.5%) were treated with ceftriaxone, 585 (23.2%) amoxicillin and 740(29.3%) amoxicillin-clavulanic acid. Out of those, 102 (4.5%) experienced adverse events (AEs), 49 (48%) were due to ceftriaxone, 37 (36.3%) amoxicillin-clavulanic acid and 16 (15.7%) amoxicillin (P-value .012). A total of 443 participants from the enrolled and WHO-Vigiflow/VigiLyze database were experienced with ADRs. The ADRs affected mainly gastro-intestinal system 234 (53%), skin and subcutaneous tissue 85 (19%), nervous system 49 (11%), respiratory thoracic 22 (5%), and general disorders 18(4%). In this study, approximately 90% of reported AEs were ADRs possible-related to the monitored medicines, with few plausible and certain. Ceftriaxone injection caused more ADRs. Amoxicillin-clavulanic acid was associated with more ADRs than amoxicillin alone. The safety profile of these medicines is still maintained; however, comprehensive monitoring of ADRs is recommended to improve patient safety and enhance overall treatment outcomes.

Keywords: adverse drug reactions; amoxicillin; amoxicillin-clavulanic acid; ceftriaxone injections; chiral medicines; prospective-retrospective cohort study.

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Conflict of interest statement

Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

References

    1. Garashi HY, Steinke DT, Schafheutle EI. A systematic review of pharmacovigilance systems in developing countries using the WHO pharmacovigilance indicators. Ther Innov Regul Sci. 2022;56(5):717-743. doi: 10.1007/s43441-022-00415-y - DOI - PMC - PubMed
    1. Zhou Y, Wu S, Zhou H, et al. Chiral pharmaceuticals: environment sources, potential human health impacts, remediation technologies and future perspective. Environ Int. 2018;121(Pt 1):523-537. doi: 10.1016/j.envint.2018.09.041 - DOI - PubMed
    1. Kumari Rayala VVSP, Kandula JS, P R. Advances and challenges in the pharmacokinetics and bioanalysis of chiral drugs. Chirality. 2022;34(10):1298-1310. doi: 10.1002/chir.23495 - DOI - PubMed
    1. Mwamwitwa KW, Kaibere RM, Fimbo AM, et al. A retrospective cross-sectional study to determine chirality status of registered medicines in Tanzania. Sci Rep. 2020;10(1):17834. doi: 10.1038/s41598-020-74932-x - DOI - PMC - PubMed
    1. Sun D, Zhang W, Yu Q, et al. Chiral penicillamine-modified selenium nanoparticles enantioselectively inhibit metal-induced amyloid β aggregation for treating Alzheimer’s disease. J Colloid Interface Sci. 2017;505:1001-1010. doi: 10.1016/j.jcis.2017.06.083 - DOI - PubMed

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