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

Yıl 2023, Cilt: 36 Sayı: 3, 351 - 360, 29.09.2023

Neriman Ipek Kırmızı Sonmez Caner Vızdıklar Volkan Aydın Onur Gultekın , Ayfer Bahar Ahmet Akıcı

https://doi.org/10.5472/marumj.1368074

Öz

Objective: 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.

Anahtar Kelimeler

Chirality, Chiral switch, Pure enantiomer, Racemate, Summary of product characteristics, Health policy

Kaynakça

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