Academic Journal

Pharmacovigilance in the treatment of cutaneous leishmaniasis: adverse event profile at a reference center.

Λεπτομέρειες βιβλιογραφικής εγγραφής
Τίτλος: Pharmacovigilance in the treatment of cutaneous leishmaniasis: adverse event profile at a reference center.
Συγγραφείς: Rezende ALS; Fundação Oswaldo Cruz, Instituto René Rachou, Núcleo de Avaliação de Tecnologias em Saúde, Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias, Belo Horizonte, MG, Brasil., Carvalho JP; Fundação Oswaldo Cruz, Instituto René Rachou, Núcleo de Avaliação de Tecnologias em Saúde, Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias, Belo Horizonte, MG, Brasil., Noronha BP; Fundação Oswaldo Cruz, Instituto René Rachou, Núcleo de Avaliação de Tecnologias em Saúde, Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias, Belo Horizonte, MG, Brasil., Silva SN; Fundação Oswaldo Cruz, Instituto René Rachou, Núcleo de Avaliação de Tecnologias em Saúde, Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias, Belo Horizonte, MG, Brasil.
Πηγή: Revista da Sociedade Brasileira de Medicina Tropical [Rev Soc Bras Med Trop] 2026 Sep 18; Vol. 59, pp. e00382026. Date of Electronic Publication: 2026 Sep 18 (Print Publication: 2026).
Τύπος έκδοσης: Journal Article; Observational Study
Γλώσσα: English
Στοιχεία περιοδικού: Publisher: Sociedade Brasileira de Medicina Tropical Country of Publication: Brazil NLM ID: 7507456 Publication Model: eCollection Cited Medium: Internet ISSN: 1678-9849 (Electronic) Linking ISSN: 00378682 NLM ISO Abbreviation: Rev Soc Bras Med Trop Subsets: MEDLINE
Imprint Name(s): Publication: <1997-> : Uberaba, MG, Brazil : Sociedade Brasileira de Medicina Tropical
Original Publication: Rio De Janeiro : Sociedade Brasileira De Medicina Tropical
Ιατρικοί όροι (MeSH): Leishmaniasis, Cutaneous*/drug therapy , Antiprotozoal Agents*/adverse effects , Phosphorylcholine*/adverse effects , Phosphorylcholine*/analogs & derivatives , Amphotericin B*/adverse effects , Meglumine*/adverse effects , Organometallic Compounds*/adverse effects , Pharmacovigilance*, Humans ; Prospective Studies ; Female ; Male ; Meglumine Antimoniate ; Adult ; Brazil ; Middle Aged ; Adolescent ; Severity of Illness Index ; Child
Περίληψη: Background: Cutaneous leishmaniasis treatment is frequently associated with adverse events (AEs). We investigated the profile of AEs and examined their associations.
Methods: This prospective observational study was conducted at a Brazilian reference center to describe AEs according to their occurrence rate, severity, and seriousness.
Results: Among 318 AEs recorded in 92 patients, the highest AE occurrence rate was among those treated with miltefosine. The highest rate of serious AEs was among patients treated with liposomal amphotericin B. Local therapy using meglumine antimoniate showed a more favorable safety profile.
Conclusion: The different profiles highlight the importance of pharmacovigilance in real-world settings.
References: Acta Trop. 2011 May;118(2):87-96. (PMID: 21420925)
Cad Saude Publica. 2018 Mar 29;34(4):e00040017. (PMID: 29617479)
Acta Trop. 2018 Jun;182:246-250. (PMID: 29550282)
PLoS One. 2025 May 23;20(5):e0324788. (PMID: 40408367)
Drug Saf. 2006;29(5):385-96. (PMID: 16689555)
Rev Inst Med Trop Sao Paulo. 2016 Sep 22;58:68. (PMID: 27680173)
Mem Inst Oswaldo Cruz. 2018 Jun 21;113(9):e180200. (PMID: 29947651)
Clin Infect Dis. 2023 Aug 22;77(4):574-582. (PMID: 37100061)
Clin Ther. 2018 Dec;40(12):1991-2004. (PMID: 30126707)
Substance Nomenclature: 0 (Antiprotozoal Agents)
107-73-3 (Phosphorylcholine)
7XU7A7DROE (Amphotericin B)
6HG8UB2MUY (Meglumine)
0 (Organometallic Compounds)
53EY29W7EC (miltefosine)
75G4TW236W (Meglumine Antimoniate)
0 (liposomal amphotericin B)
Entry Date(s): Date Created: 20260925 Date Completed: 20260925 Latest Revision: 20260930
Update Code: 20260930
PubMed Central ID: PMC13592860
DOI: 10.1590/0037-8682-0038-2026
PMID: 42788576
Βάση Δεδομένων: MEDLINE
Περιγραφή
ISSN:1678-9849
DOI:10.1590/0037-8682-0038-2026