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

Onakpoya, Igho J.; Heneghan, Carl J.; Aronson, Jeffrey K.

doi:10.1186/s12916-016-0735-y

Table 1 List of anti-obesity drugs withdrawn from the market because of adverse drug reactions

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

Medicinal product	Primary mechanism of action	Therapeutic indication	Launch date	Year of first ADR report	Year first withdrawn	Countries withdrawn	Primary reason for withdrawal	Level of evidence^a
Amfepramone (diethylpropion)^b	SNDRA	Obesity	1957	1974	1975	Turkey, Sweden, Oman, UAE, Norway, Venezuela, EU, France, UK, Brazil	Cardiotoxicity	4
Amphetamine	SNDRA	Obesity, narcolepsy	1939	1957	1973	USA, UAE, Turkey, Oman, Malaysia, Nigeria	Drug abuse and dependence	4
Aminorex fumarate^c	SRI	Obesity	1962	1967	1967	Germany, Venezuela, Switzerland, Austria	Cardiotoxicity	4
Benfluorex^c	SRI	Obesity, diabetes	1976	2003	2009	Europe	Cardiotoxicity	3
Chlorphentermine	SRI	Obesity	1962		1969	Germany, Venezuela	Cardiotoxicity	5
Clobenzorex	SNDRA	Obesity	1966	1986	2000	Mauritius, USA, Oman	Drug abuse, psychiatric	4
Cloforex	SRI	Obesity	1965	1967	1967	Germany, Sweden, Venezuela	Cardiotoxicity	4
Cyclovalone + retinol + tiratricol	Bile acid secretion	Hyperlipidemia, dyspepsia, obesity	1964	1984	1988	France	Liver toxicity	4
Dexfenfluramine	SRI	Obesity	1995	1995	1997	Worldwide	Cardiotoxicity	4
Fenbutrazate	NDRA	Obesity	1957	1963	1969	Europe	Drug abuse, psychiatric	2
Fenfluramine^c	SRI	Obesity	1973	1981	1997	Worldwide	Cardiotoxicity	3
Fenproporex (perphoxene)	NRA	Obesity, narcolepsy, ADHD	1966	1997	1999	Europe, Brazil	Drug abuse, psychiatric	4
Iodinated casein strophanthin	Thyroxine analogue	Obesity	1944	1964	1964	USA	Endocrine, metabolism	4
Levamphetamine	SNDRA	Obesity	1944	1954	1973	USA, Oman, UAE	Drug abuse and dependence	4
Mazindol	NRDA	Obesity	1970	1980	1987	Oman, Brazil	Drug abuse, psychiatric (interaction with lithium)	4
Mefenorex (methylphenethylamine)	SNDRA	Obesity	1966	1995	1999	Europe, Oman	Drug abuse, psychiatric	4
Methamphetamine (desoxyephedrine)^c	SNDRA	ADHD, obesity	1944	1971	1973	USA, Turkey, Oman, Nigeria	Drug abuse, drug dependence	4
Phendimetrazine	NDRA		1961	1979	1982	Turkey	Drug abuse	4
Phenmetrazine	NDRA	Obesity	1956	1959	1982	Turkey, Oman, Nigeria	Drug abuse	4
Phentermine^b,c	NDRA	Obesity	1959	1964	1981	Sweden, UAE, Mauritius, Turkey, Oman, UK, Venezuela	Drug abuse	4
Phenylpropanolamine (norpseudoephedrine)	NDRA	Nasal decongestion, obesity	1947	1985	1987	Germany, Brazil, Malaysia, Singapore, USA, Oman, Canada, Cuba, India	Hemorrhagic stroke	4
Pipradrol	NDRI	Obesity, narcolepsy, ADHD	1953	1968	1982	USA, Turkey, Denmark, Venezuela	Drug abuse	4
Pyrovalerone	NDRA	Obesity, chronic fatigue syndrome	1974	1975	1979	France	Drug abuse	4
Rimonabant^c	CB₁ antagonist/inverse agonist	Obesity	2006	2006	2007	Europe, India	Psychiatric	1
Sibutramine^c	SNRI	Obesity	2001	2002	2002	EU; 4 Asian countries; Australia; Canada; Mexico; New Zealand; USA	Cardiotoxicity, psychiatric	4

ADHD attention deficit hyperactivity disorder, ADR adverse drug reaction, CB₁ cannabinoid 1 (receptors), EU European Union, NRA norepinephrine releasing agent, NDRA norepinephrine-dopamine releasing agent, NDRI norepinephrine-dopamine re-uptake inhibitor, SNDRA serotonin-norepinephrine-dopamine releasing agent, SNRI serotonin-norepinephrine re-uptake inhibitor, SRI serotonin re-uptake inhibitor, UAE United Arab Emirates
^aBased on the Oxford Centre for Evidence-Based Medicine Levels of Evidence [17]. Level 1: systematic review of randomized trials, systematic review of nested case-control studies, Level 2: individual randomized trial or (exceptionally) observational study with dramatic effect; Level 3: non-randomized controlled cohort/follow-up study (post-marketing surveillance); Level 4: case-series, case-control, or historically controlled studies; Level 5: mechanism-based reasoning
^bRe-introduced in the EU based on long-standing legal action unrelated to either new safety or new efficacy information
^cReported to have caused deaths

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ISSN: 1741-7015

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