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Cited by 616

The DOI matches its Crossref record; 33 of the 33 references it cites were found in a registry or an index.

Post-marketing withdrawal of 462 medicinal products because of adverse drug reactions: a systematic review of the world literature

Open access
Onakpoya, Igho J., Heneghan, Carl J., Aronson, Jeffrey K.·2016·BMC Medicine
DOI 10.1186/s12916-016-0553-2
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Abstract

BACKGROUND: There have been no studies of the patterns of post-marketing withdrawals of medicinal products to which adverse reactions have been attributed. We identified medicinal products that were withdrawn because of adverse drug reactions, examined the evidence to support such withdrawals, and explored the pattern of withdrawals across countries. METHODS: We searched PubMed, Google Scholar, the WHO's database of drugs, the websites of drug regulatory authorities, and textbooks. We included medicinal products withdrawn between 1950 and 2014 and assessed the levels of evidence used in making withdrawal decisions using the criteria of the Oxford Centre for Evidence Based Medicine. RESULTS: We identified 462 medicinal products that were withdrawn from the market between 1953 and 2013, the most common reason being hepatotoxicity. The supporting evidence in 72 % of cases consisted of anecdotal reports. Only 43 (9.34 %) drugs were withdrawn worldwide and 179 (39 %) were withdrawn in one country only. Withdrawal was significantly less likely in Africa than in other continents (Europe, the Americas, Asia, and Australasia and Oceania). The median interval between the first reported adverse reaction and the year of first withdrawal was 6 years (IQR, 1-15) and the interval did not consistently shorten over time. CONCLUSION: There are discrepancies in the patterns of withdrawal of medicinal products from the market when adverse reactions are suspected, and withdrawals are inconsistent across countries. Greater co-ordination among drug regulatory authorities and increased transparency in reporting suspected adverse drug reactions would help improve current decision-making processes.

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Show all 33 references

Research works printed but not linked: 13

  1. Sullivan JW. A pharmaceutical manufacturer’s perspective on reporting adverse drug experiences. Am J Hosp Pharm. 1990;47:1342–5.
  2. Anonymous. New contraindication added to Reclast drug label. Reactions Weekly. 2011;1368:3.
  3. Eyal N. Reconciling informed consent with prescription drug requirements. J Med Ethics. 2012;38:589–91. · doi:10.1136/medethics-2012-100667
  4. Pharmaceutical Manufacturing Encyclopedia. Norwich, NY: William Andrew Publishing; 2007. · doi:10.1016/b978-0-8155-1526-5.50020-9
  5. OCEBM Levels of Evidence Working Group. The Oxford 2011 Levels of Evidence. Oxford Centre for Evidence-Based Medicine. http://www.cebm.net/index.aspx?o=5653 . Accessed 18 Jun 2015.
  6. Appiah B. Africa struggles to improve drug safety. CMAJ. 2012;184:E533–4. · doi:10.1503/cmaj.109-4199
  7. World Health Organization. African Medicines Agency: Setting Milestones Towards its Establishment, 1 April 2014. AUC/WHO/2014/Doc.2. Geneva: WHO; 2014.
  8. Anonymous. US pharmacovigilance system in need of an overhaul? Reactions Weekly. 2004;1029:3.
  9. Pérez García M, Figueras A. The lack of knowledge about the voluntary reporting system of adverse drug reactions as a major cause of underreporting: direct survey among health professionals. Pharmacoepidemiol Drug Saf. 2011;20:1295–302. · doi:10.1002/pds.2193
  10. Biagi C, Montanaro N, Buccellato E, Roberto G, Vaccheri A, Motola D. Underreporting in pharmacovigilance: an intervention for Italian GPs (Emilia-Romagna region). Eur J Clin Pharmacol. 2013;69:237–44. · doi:10.1007/s00228-012-1321-7
  11. Kiguba R, Karamagi C, Waako P, Ndagije HB, Bird SM. Recognition and reporting of suspected adverse drug reactions by surveyed healthcare professionals in Uganda: key determinants. BMJ Open. 2014;4:e005869. · doi:10.1136/bmjopen-2014-005869
  12. Furberg BD, Furberg CD. How are adverse drug reactions measured? In: Furberg BD, Furberg CD, editors. Evaluating Clinical Research: All that glitters is not gold. New York: Springer Science + Business Media, LLC; 2007. p. 67–71. · doi:10.1007/978-0-387-72899-5_14
  13. Abraham J, Davis C. A comparative analysis of drug safety withdrawals in the UK and the US (1971–1992): implications for current regulatory thinking and policy. Soc Sci Med. 2005;61:881–92. · doi:10.1016/j.socscimed.2005.01.004

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Metadata

Authors
Onakpoya, I. J., Heneghan, C. J., & Aronson, J. K.
Venue
BMC Medicine
Publisher
Springer Science and Business Media LLC
Published
2016-02-04
Volume
14
Issue
1
Pages
10-10
ISSN
1741-7015 (ISSN-L)
DOI
10.1186/s12916-016-0553-2
OpenAlex
W2269807470
Cited by
616
References
33
FWCI
10.87
Type
journal article
Language
en
Update notices
correction (2019-03-02)
Open access
gold

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CoChat. (2026). Citation check: Post-marketing withdrawal of 462 medicinal products because of adverse drug reactions: a systematic review of the world literature. https://app.cochat.ai/papers/10.1186/s12916-016-0553-2
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Onakpoya, I. J., Heneghan, C. J., & Aronson, J. K. (2016). Post-marketing withdrawal of 462 medicinal products because of adverse drug reactions: a systematic review of the world literature. BMC Medicine. https://doi.org/10.1186/s12916-016-0553-2

Data sources

Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.