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...

Deskribapen osoa

Xehetasun bibliografikoak
Egile Nagusiak:	Onakpoya, I, Heneghan, C, Aronson, J
Formatua:	Journal article
Hizkuntza:	English
Argitaratua:	Wiley 2017

Antzeko izenburuak

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

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

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

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

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

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

Post-marketing regulation of medicines withdrawn from the market because of drug-attributed deaths: An analysis of justification.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

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

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

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

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

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

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

Postmarket sequential database surveillance of medical products
nork: Maro, Judith C
Argitaratua: (2013)

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

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

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

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

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

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

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

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

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

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

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

Pharmacogenetics and adverse drug reactions
nork: Ferner, R, et al.
Argitaratua: (2010)

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

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

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

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

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

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

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

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

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

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

Adverse drug reactions: definitions, diagnosis, and management.
nork: Edwards, I, et al.
Argitaratua: (2000)

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

Postmarketing assessment of a switchable similar anastrozole product in Brazilian breast cancer patients
nork: Manuela Vasquez Cardoso, et al.
Argitaratua: (2023-04-01)

Case reports of suspected adverse drug reactions--systematic literature survey of follow-up.
nork: Loke, Y, et al.
Argitaratua: (2006)