The impact of chiral switch on drug labeling in Turkey: Indication, posology, and adverse effects

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dc.authorid0000-0002-8511-6349
dc.contributor.authorKırmızı Sönmez, Neriman İpek
dc.contributor.authorVızdıklar, Caner
dc.contributor.authorAydın, Volkan
dc.contributor.authorGültekin, Onur
dc.contributor.authorBahar, Ayfer
dc.contributor.authorAkıcı, Ahmet
dc.date.accessioned2023-10-27T11:45:45Z
dc.date.available2023-10-27T11:45:45Z
dc.date.issued2023
dc.departmentİstanbul Medipol Üniversitesi, Uluslararası Tıp Fakültesi, Dahili Tıp Bilimleri Bölümü, Tıbbi Farmakoloji Ana Bilim Dalı
dc.description.abstractObjective: Chiral switch, which involves replacing racemic drugs to market them as pure enantiomers, is presumed to improve efficacy and safety. Data on how chiral switch-related changes are represented in summary of product characteristics (SmPC) is scarce. We aimed to compare the indication, posology, and safety expressions in SmPCs of racemates and their pure enantiomers. Materials and Methods: We examined SmPCs of nine drug pairs (racemate/pure enantiomer) that underwent chiral switching among top 100 utilized active substances throughout Turkey. We evaluated the expressions in “indications”, “posology”, and “adverse effects” (AE) subheadings. Daily doses were examined based on “Defined Daily Dose” (DDD) metric. Results: We detected indication differences in four drug pairs, including absence of “peptic ulcer” in dexlansoprazole and “prevention of depression relapses” in escitalopram. DDDs of pure enantiomers decreased in most of the pairs. Recommended daily doses of esomeprazole and dexibuprofen per DDD were lower than their racemates. Cautions about use in renal and/or hepatic insufficiency varied in three pairs. AE expressions differed in seven drug pairs, mainly citalopram/escitalopram. Conclusion: This study demonstrated few indication differences in SmPCs of the drug pairs frequently used in Turkey and underwent chiral switching. However, dose reductions and distinctions in safety expressions were remarkable.
dc.identifier.citationKırmızı Sönmez, N. İ., Vızdıklar, C., Aydın, V., Gültekin, O., Bahar, A. ve Akıcı, A. (2023). The impact of chiral switch on drug labeling in Turkey: Indication, posology, and adverse effects. Marmara Medical Journal, 36(3), 351-360. https://dx.doi.org/10.5472/marumj.1368074
dc.identifier.doi10.5472/marumj.1368074
dc.identifier.endpage360
dc.identifier.issn1019-1941
dc.identifier.issue3
dc.identifier.scopus2-s2.0-85173933345
dc.identifier.scopusqualityQ4
dc.identifier.startpage351
dc.identifier.urihttps://dx.doi.org/10.5472/marumj.1368074
dc.identifier.urihttps://hdl.handle.net/20.500.12511/11659
dc.identifier.volume36
dc.identifier.wos001108759200005en_US
dc.identifier.wosqualityN/A
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.institutionauthorAydın, Volkan
dc.language.isoen
dc.publisherMarmara University
dc.relation.ispartofMarmara Medical Journalen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectChiral Switch
dc.subjectChirality
dc.subjectHealth Policy
dc.subjectPure Enantiomer
dc.subjectRacemate
dc.subjectSummary of Product Characteristics
dc.titleThe impact of chiral switch on drug labeling in Turkey: Indication, posology, and adverse effects
dc.typeArticle

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