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Cited by 171Pharmacology and Obesity TreatmentPharmacovigilance and Adverse Drug ReactionsPharmaceutical industry and healthcare

The DOI matches its Crossref record; 52 of the 52 references it cites were found in a registry or an index.

Post-marketing withdrawal of anti-obesity medicinal products because of adverse drug reactions: a systematic review

Open access
Onakpoya, Igho J., Heneghan, Carl J., Aronson, Jeffrey K.·2016·BMC Medicine
DOI 10.1186/s12916-016-0735-yPMC PMC5126837
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Abstract

BACKGROUND: We identified anti-obesity medications withdrawn since 1950 because of adverse drug reactions after regulatory approval, and examined the evidence used to support such withdrawals, investigated the mechanisms of the adverse reactions, and explored the trends over time. METHODS: We conducted searches in PubMed, the World Health Organization database of drugs, the websites of drug regulatory authorities, and selected full texts, and we hand searched references in retrieved documents. We included anti-obesity medications that were withdrawn between 1950 and December 2015 and assessed the levels of evidence used for making withdrawal decisions using the Oxford Centre for Evidence-Based Medicine criteria. RESULTS: We identified 25 anti-obesity medications withdrawn between 1964 and 2009; 23 of these were centrally acting, via monoamine neurotransmitters. Case reports were cited as evidence for withdrawal in 80% of instances. Psychiatric disturbances, cardiotoxicity (mainly attributable to re-uptake inhibitors), and drug abuse or dependence (mainly attributable to neurotransmitter releasing agents) together accounted for 83% of withdrawals. Deaths were reportedly associated with seven products (28%). In almost half of the cases, the withdrawals occurred within 2 years of the first report of an adverse reaction. CONCLUSIONS: Most of the drugs that affect monoamine neurotransmitters licensed for the treatment of obesity over the past 65 years have been withdrawn because of adverse reactions. The reasons for withdrawal raise concerns about the wisdom of using pharmacological agents that target monoamine neurotransmitters in managing obesity. Greater transparency in the assessment of harms from anti-obesity medications is therefore warranted.

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Fig. 1 Interval between first ADR reports and first withdrawals. The red boxes indicate products to which deaths were attributed
Fig. 1 Interval between first ADR reports and first withdrawals. The red boxes indicate products to which deaths were attributedCC BY · PubMed Central

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Research works printed but not linked: 3

  1. OCEBM Levels of Evidence Working Group. The Oxford 2011 Levels of Evidence. Oxford Centre for Evidence-Based Medicine. 2016. http://www.cebm.net/ocebm-levels-of-evidence/ .
  2. Price K. Case notes: phentermine. Bull Int Assoc Foren Toxicol. 1974;10(1):12.
  3. Anonymous. Italy suspends sibutramine licence. Pharm J. 2002;268(7190):385–91.

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Metadata

Authors
Onakpoya, I. J., Heneghan, C. J., & Aronson, J. K.
Affiliations
University of Oxford (GB)
Corresponding author
Onakpoya, Igho J.
ORCID
Venue
BMC Medicine
Publisher
Springer Science and Business Media LLC
Published
2016-11-29
Volume
14
Issue
1
Pages
191-191
ISSN
1741-7015 (ISSN-L)
DOI
10.1186/s12916-016-0735-y
PMC
PMC5126837
OpenAlex
W2551793627
Cited by
171
References
52
Citations by year
2026: 9 · 2025: 15 · 2024: 26 · 2023: 24 · 2022: 13 · 2021: 20 · 2020: 17 · 2019: 15 · 2018: 24 · 2017: 7 · 2016: 1
FWCI
1.79
Type
journal article
Language
en
Open access
Licence
Locations
  • BMC Medicine (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
Funders
  • Wellcome Trust
  • National Institute for Health and Care Research
  • British Pharmacological Society
  • University of Oxford
  • U.S. Food and Drug Administration
  • NIHR School for Primary Care Research
  • Clarendon Fund
Topics
  • Health Sciences › Medicine › Pharmacology (medical) › Pharmacology and Obesity Treatment
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
  • Health Sciences › Nursing › Issues, ethics and legal aspects › Pharmaceutical industry and healthcare
Keywords
anti-obesity drugs, drug withdrawal, adverse drug reactions, monoamines, psychiatric disturbances, cardiotoxicity, drug addiction, drug abuse, level of evidence, regulatory decision-making, obesity treatment
MeSH terms
Humans, Obesity, Product Surveillance, Postmarketing, Safety-Based Drug Withdrawals, Drug-Related Side Effects and Adverse Reactions

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