Postmarketing withdrawal of human medicinal products because of adverse reactions in animals: a systematic review and analysis.

Postmarketing withdrawal of human medicinal products because of adverse reactions in animals: a systematic review and analysis.

<h4>Purpose</h4> <p>We have identified human medicinal products for which animal data were used as evidence for withdrawal, determined whether the adverse reactions were reported in humans, established whether confirmatory human studies were conducted, and explored the withdrawal...

Descrizione completa

Dettagli Bibliografici
Autori principali:	Onakpoya, I, Heneghan, C, Aronson, J
Natura:	Journal article
Lingua:	English
Pubblicazione:	Wiley 2017

Documenti analoghi

Worldwide withdrawal of medicinal products because of adverse drug reactions: a systematic review and analysis
di: Onakpoya, I, et al.
Pubblicazione: (2016)

Post-marketing withdrawal of anti-obesity medicinal products because of adverse drug reactions: a systematic review.
di: Onakpoya, I, et al.
Pubblicazione: (2016)

Post-marketing withdrawal of 462 medicinal products because of adverse drug reactions: a systematic review of the world literature
di: Onakpoya, IJ, et al.
Pubblicazione: (2016)

Post-marketing withdrawal of analgesic medications because of adverse drug reactions: a systematic review
di: Onakpoya, I, et al.
Pubblicazione: (2017)

Correction to: Post-marketing withdrawal of 462 medicinal products because of adverse drug reactions: a systematic review of the world literature
di: Igho J. Onakpoya, et al.
Pubblicazione: (2019-03-01)

An evidence-based approach to the post-marketing withdrawal of medicinal products because of adverse reactions
di: Onakpoya, I
Pubblicazione: (2017)

Post-marketing regulation of medicines withdrawn from the market because of drug-attributed deaths: An analysis of justification.
di: Onakpoya, I, et al.
Pubblicazione: (2017)

The Adverse Drug Reactions Registered During the Postmarketing Period
di: E. V. Shubnikova, et al.
Pubblicazione: (2019-03-01)

Rotavirus Vaccine Withdrawal in the United States: The Role of Postmarketing Surveillance
di: Gilles Delage
Pubblicazione: (2000-01-01)

Benefits and harms in pivotal trials of oral centrally acting antiobesity medicines: A systematic review and meta-analysis.
di: Onakpoya, I, et al.
Pubblicazione: (2018)

Postmarketing Surveillance of Full Spectrum Hemp Extract CBD Products: Reported Adverse Events and Serious Adverse Events
di: Colleen M. Kingsbury, et al.
Pubblicazione: (2024-09-01)

Signals of adverse drug reactions communicated by pharmacovigilance stakeholders: protocol for a scoping review of the global literature
di: Daniele Sartori, et al.
Pubblicazione: (2020-08-01)

Analysis of postmarketing neuropsychiatric adverse events of avapritinib based on the FDA adverse event reporting system
di: Wei Mao, et al.
Pubblicazione: (2025-01-01)

Postmarket sequential database surveillance of medical products
di: Maro, Judith C
Pubblicazione: (2013)

Adverse events with risankizumab in the real world: postmarketing pharmacovigilance assessment of the FDA adverse event reporting system
di: Yamin Shu, et al.
Pubblicazione: (2023-05-01)

Redefining rapid reviews: a flexible framework for restricted systematic reviews
di: Plüddemann, A, et al.
Pubblicazione: (2018)

Postmarket Surveillance of Neuroendovascular Devices
di: Marie K. Luff, et al.
Pubblicazione: (2024-03-01)

Postmarket Drug Surveillance Without Trial Costs: Discovery of Adverse Drug Reactions Through Large-Scale Analysis of Web Search Queries
di: Yom-Tov, Elad, et al.
Pubblicazione: (2013-06-01)

Safety of oral nemonoxacin: A systematic review of clinical trials and postmarketing surveillance
di: Jinyi Yuan, et al.
Pubblicazione: (2022-12-01)

Naltrexone‐bupropion (Mysimba®) in management of obesity: A systematic review and meta‐analysis of unpublished clinical study reports
di: Onakpoya, IJ, et al.
Pubblicazione: (2020)

Postmarketing pharmacovigilance: Remdesivir and cardiovascular events
di: John T. Sullivan
Pubblicazione: (2022-04-01)

Publishing histories of adverse reactions to medicaments anecdotally: the PHARMA guidelines for reporting suspected adverse drug reactions.
di: Aronson, J
Pubblicazione: (2008)

Use of real-world evidence in postmarketing medicines regulation in the European Union: a systematic assessment of European Medicines Agency referrals 2013–2017
di: Kevin Wing, et al.
Pubblicazione: (2019-10-01)

An agenda for research on adverse drug reactions.
di: Aronson, J
Pubblicazione: (2007)

Adverse drug reactions--no farewell to harms.
di: Aronson, J
Pubblicazione: (2007)

Pharmacogenetics and adverse drug reactions
di: Ferner, R, et al.
Pubblicazione: (2010)

Clinical efficacy and safety of alemtuzumab in postmarketing practice
di: N. V. Khachanova
Pubblicazione: (2019-06-01)

Withdrawn medicines included in the essential medicines lists of 136 countries.
di: Onella Charles, et al.
Pubblicazione: (2019-01-01)

Comparison of Data Mining Methods for the Signal Detection of Adverse Drug Events with a Hierarchical Structure in Postmarketing Surveillance
di: Goeun Park, et al.
Pubblicazione: (2020-08-01)

Postmarketing surveillance of adverse events following meningococcal B vaccination: data from Apulia Region, 2014–19
di: Pasquale Stefanizzi, et al.
Pubblicazione: (2022-01-01)

Serum trough level as a postmarketing quality measure of generic vancomycin products
di: Ya-Wen Tsai, et al.
Pubblicazione: (2020-04-01)

Postmarketing Surveillance: Review of Open Sources of Drug Safety Data
di: E. V. Shubnikova
Pubblicazione: (2024-10-01)

Effect of the natural sweetener, steviol glycoside, on cardiovascular risk factors: A systematic review and meta-analysis of randomised clinical trials.
di: Onakpoya, I, et al.
Pubblicazione: (2014)

The need for randomization in animal trials: an overview of systematic reviews
di: Hirst, J, et al.
Pubblicazione: (2014)

Reduced salt intake for heart failure: A systematic review
di: Mahtani, K, et al.
Pubblicazione: (2018)

Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process.
di: Heneghan, C, et al.
Pubblicazione: (2017)

Orphan Therapies: Making Best Use of Postmarket Data
di: Li, Lingling, et al.
Pubblicazione: (2016)

Postmarketing safety evaluation of belimumab: a pharmacovigilance analysis
di: Huqun Li, et al.
Pubblicazione: (2025-01-01)

Pharmacoepidemiology – Assessing the Risks and Benefits of Drugs in the Postmarketing Phase
di: Christoph R. Meier
Pubblicazione: (2006-02-01)

Sleep-walking with zolpidem: Need for continued postmarketing surveillance
di: Ajitha Sharma, et al.
Pubblicazione: (2015-01-01)