Evidence map›Paper›PMID 35821561›Full record

ArticleDrug safety2022

Safety-Related Drug Withdrawals in China Between 1999 and 2021: A Systematic Investigation and Analysis.

Yanrong Li, Yang Jiang, Haixue Wang, Li Zhang, Yue Yang

Abstract read
In one paragraph

Article in Drug safety, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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2 · The registry

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3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Yanrong LiCentre for Drug Evaluation, National Medical Products Administration, Beijing, China.
Yang JiangSchool of Pharmaceutical Sciences, Tsinghua University, Beijing, China.
Haixue WangCentre for Drug Evaluation, National Medical Products Administration, Beijing, China.
Li ZhangDongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.
Yue YangSchool of Pharmaceutical Sciences, Tsinghua University, Beijing, China. yanghappy@mail.tsinghua.edu.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe Chinese National Medical Products Administration (NMPA) has emphasized proactive pharmacovigilance throughout the product life cycle in recent years. However, the safety-related withdrawal of drugs from the Chinese market has received less attention.

objectivesThe primary aim of the study was to investigate the context of withdrawing a drug for safety reasons in China (between 1999 and 2021).

methodsWithdrawn drugs were first identified from the Chinese NMPA and United States (US) Food and Drug Administration websites and the World Health Organization's (WHO's) consolidated list of products, WHO Drug Information, and WHO Pharmaceuticals Newsletter. We then searched the China National Knowledge Internet database, Chongqing VIP information database, Wanfang database, PubMed, and Google Scholar for drug withdrawal details. We used the Oxford Centre for Evidence-Based Medicine criteria to assess the levels of evidence that support withdrawing a drug.

resultsA total of 30 drugs were withdrawn from the Chinese market between 1999 and 2021. The number of withdrawals increased during the stable Chinese drug surveillance period (2012-2021). Evidence from case-series or case-control studies was primarily used to determine the withdrawals of 16 drugs (53.3%). Fifteen drugs were withdrawn from the markets of China and the US, including five drugs (5/15, 33.3%) that were withdrawn in the same year in China and the US.

conclusionsThe promulgation of regulations and development of advanced passive and active systems have enhanced pharmacovigilance in China. High-quality evidence, coordination with other regulatory authorities, and communication and information sharing should be strengthened to optimize drug safety surveillance and risk management.

Indexed as

PharmacovigilanceSafety-Based Drug WithdrawalsCase-Control StudiesChinaDatabases, FactualEvidence-Based MedicineHumans

Identifiers

PMID35821561
PMCPMC9296427

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