Fatal adverse effects of injected ceftriaxone sodium in China

Yao, Yi; Zhou, Ranyun; Wang, Ying

doi:10.1002/pds.3232

Cited by 14 publications

(16 citation statements)

References 7 publications

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“…Another 12 new signals were detected in Korea on the use of amoxicillin including ineffective amoxicillin 43 , however, the chirality factor was not reported to be associated with the new signals. In addition, a concern on safety of ceftriaxone has been reported for both adults and children 44,45 . Fatal adverse effects of injected ceftriaxone sodium were reported in China, the reason among others being the possibility of poor drug quality 45 .…”

Section: Discussionmentioning

confidence: 99%

A retrospective cross-sectional study to determine chirality status of registered medicines in Tanzania

Mwamwitwa

Kaibere

Fimbo³

et al. 2020

Sci Rep

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Medicines with a stereogenic center (asymmetric carbon) are mainly present as racemates with a mixture of equal amounts of enantiomers. One enantiomer may be active while the other inactive, alternatively one may produce side-effects and even toxicity. However, there is lack of information on the chirality status (either racemates, single active enantiomer or achiral) of medicines circulated on the market particularly in African countries. We established the chirality status of registered medicines in Tanzania by conducting a retrospective cross-sectional study. Registration data for the past 15 years from 2003 to 2018 were extracted from TMDA-IMIS database to Microsoft excel for review and analysis. A total of 3,573 human medicines had valid registration. Out of which 2,150 (60%) were chiral and 1,423 (40%) achiral. Out of the chiral medicines, 1,591 (74%) and 559 (26%) were racemates and single active enantiomers, respectively. The proportion of racemates within chiral medicines was considerably higher than single enantiomer medicines. The use of racemates may cause harm to the public and may contribute to antimicrobial resistance due to potential existence of inactive and toxic enantiomers. In order to protect public health, regulatory bodies need to strengthen control of chiral medicines by conducting analysis of enantiomeric impurity.

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Section: Discussionmentioning

confidence: 99%

A retrospective cross-sectional study to determine chirality status of registered medicines in Tanzania

Mwamwitwa

Kaibere

Fimbo³

et al. 2020

Sci Rep

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show abstract

“…In addition, a concern on safety of ceftriaxone has been reported for both adults and children [46,47]. Fatal adverse effects of injected ceftriaxone sodium were reported in China, the reason among others being the possibility of poor drug quality [47]. The results of our current study also call for more investigation to be conducted on safety and quality control of medicines especially anti-infective medicines, which are mostly used in the public.…”

Section: Discussionmentioning

confidence: 56%

“…Other 12 new signals were detected in Korea on the use of amoxicillin including ineffective amoxicillin [45], however, the chirality factor was not reported to be associated with the new signals. In addition, a concern on safety of ceftriaxone has been reported for both adults and children [46,47]. Fatal adverse effects of injected ceftriaxone sodium were reported in China, the reason among others being the possibility of poor drug quality [47].…”

Section: Discussionmentioning

confidence: 99%

Chirality Status Of Registered Medicines In Tanzania: A Retrospective Cross-Sectional Study

Mwamwitwa¹,

Kaibere²,

Fimbo³

et al. 2020

Preprint

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Background Medicines with a stereogenic center (asymmetric carbon) mainly presents as racemates with a mixture of equal amounts of enantiomers. One enantiomer may be active while the other inactive, alternatively one may produce side-effects and even toxicity. Worldwide there is no mandatory regulatory requirement to enforce the development of new chiral medicines as exclusively pure active single enantiomers. This has contributed to the existence of both single enantiomers and racemates on the market. Moreover, literature shows the tendency of regulatory approval of medicines towards the development of pure single enantiomers 60%, only 5–10% racemates and 30–35% as achiral. This status has not been established particularly in African countries including Tanzania. Therefore, we aimed to establish the chirality status of registered medicines in Tanzania. Methodology: A retrospective cross-sectional study was conducted by reviewing all human medicines registered in Tanzania for the past 15 years from 2003 to 2018. Data were extracted from TMDA-IMIS database to Microsoft excel for analysis. Medicines were assessed to determine if they were chiral (racemates or single enantiomers) or achiral. Results A total of 3,573 human medicines had valid registration. Most of these medicines 2,150 (60%) are chiral and 1,423 (40%) are achiral. Out of the chiral medicines, 1,591 (74%) and 559 (26%) were racemates and single enantiomers, respectively. The percentage of chiral medicines for anti-infective (35%) was significantly higher (p < 0.0001) than other pharmacological groups. A high proportion of chiral medicines within pharmacological groups were observed in systemic hormonal preparations (excluding reproductive hormones and insulin) 97.3% (36/37) and anti-infectives 80% (753/941). Conclusion The study revealed the existence of both chiral and achiral registered human medicines with chiral medicines predominating. The proportion of racemates within chiral medicines was significantly higher than that of single enantiomer medicines. The use of these racemates may cause harm to the public and may also contribute to antimicrobial resistance due to the potential existence of inactive and toxic enantiomers. In order to protect public health, regulatory bodies need to strengthen the control of chiral medicines by including an analysis of enantiomeric impurity.

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“…Çocuklarda az sayıda da olsa da anafilaksi vakaları bilinmektedir. Çin'de yapılan bir çalışmada seftriaksona bağlı 22 anafilaksi vakasının 4'ünün çocuk olduğu bildirilmiştir (9) . Anafilaksi ilk 20 dk.…”

Section: Günümüzde Sefalosporinler Ve Antibiyotik Direnciunclassified