Skip to main page content
Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2016 Nov 29;14(1):191.
doi: 10.1186/s12916-016-0735-y.

Post-marketing Withdrawal of Anti-Obesity Medicinal Products Because of Adverse Drug Reactions: A Systematic Review

Free PMC article

Post-marketing Withdrawal of Anti-Obesity Medicinal Products Because of Adverse Drug Reactions: A Systematic Review

Igho J Onakpoya et al. BMC Med. .
Free PMC article


Background: We identified anti-obesity medications withdrawn since 1950 because of adverse drug reactions after regulatory approval, and examined the evidence used to support such withdrawals, investigated the mechanisms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 We included anti-obesity medications that were withdrawn between 1950 and December 2015 and assessed the levels of evidence used for making withdrawal decisions using the Oxford Centre for Evidence-Based Medicine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Results: We identified 25 anti-obesity medications withdrawn between 1964 and 2009; 23 of these were centrally acting, via monoamine neurotransmitters.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drugs that affect monoamine neurotransmitters licensed for the treatment of obesity over the past 65 years have been withdrawn because of adverse reactions.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.

Keywords: Adverse drug reaction; Drug withdrawal; Obesity; Systematic review.


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

Similar articles

See all similar articles

Cited by 20 articles

See all "Cited by" articles


    1. Rodgers RJ, Tschöp MH, Wilding JP. Anti-obesity drugs: past, present and future. Dis Model Mech. 2012;5(5):621–6. doi: 10.1242/dmm.009621. - DOI - PMC - PubMed
    1. Cawley J, Meyerhoefer C, Biener A, Hammer M, Wintfeld N. Savings in medical expenditures associated with reductions in body mass index among US adults with obesity, by diabetes status. Pharmacoeconomics. 2015;33(7):707–22. doi: 10.1007/s40273-014-0230-2. - DOI - PMC - PubMed
    1. Butland B, Jebb S, Kopelman P, McPherson K, Thomas S, Mardell J, Parry V. Tackling obesities: future choices – project report. 2. London: Foresight Programme of the Government Office for Science; 2007.
    1. World Health Organisation. Obesity and overweight. Fact sheet No.311 Updated January 2015. Accessed 20 Mar 2016.
    1. Dietz WH, Baur LA, Hall K, Puhl RM, Taveras EM, Uauy R, Kopelman P. Management of obesity: improvement of health-care training and systems for prevention and care. Lancet. 2015;385(9986):2521–33. doi: 10.1016/S0140-6736(14)61748-7. - DOI - PubMed

MeSH terms