List of withdrawn drugs

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Overview

Some drugs have been withdrawn from the market because of risks to the patients. Usually this has been prompted by unexpected adverse effects that were not detected during Phase III clinical trials and were only apparent from post-marketing surveillance data from the wider patient community.

Significant withdrawals

Drug name Withdrawn Remarks
thalidomide 1950s–1960s Withdrawn due to risk of teratogenicity; returned to market for use in leprosy and multiple myeloma under FDA orphan drug rules
lysergic acid diethylamide (LSD) 1950s–1960s Marketed as a psychiatric cure-all; withdrawn after it became widely used recreationally
diethylstilbestrol 1970s Withdrawn due to risk of teratogenicity
phenformin and buformin 1978 Withdrawn due to risk of lactic acidosis
ticrynafen 1982 Withdrawn due to risk of hepatitis
zimelidine 1983 Withdrawn worldwide due to risk of Guillain-Barré syndrome
methaqualone 1984 Withdrawn due to risk of addiction and overdose
triazolam 1991 Withdrawn in the United Kingdom due to risk of psychiatric adverse drug reactions. This drug continues to be available in the U.S.
Fen-phen (popular combination of fenfluramine and phentermine) 1997 Phentermine remains on the market, dexfenfluramine and fenfluramine – later withdrawn as caused heart valve disorder
terfenadine 1998 Withdrawn due to risk of cardiac arrhythmias; superseded by fexofenadine
mibefradil 1998 Withdrawn due to dangerous interactions with other drugs
troglitazone 2000 Withdrawn due to risk of hepatotoxicity; superseded by pioglitazone and rosiglitazone
alosetron 2000 Withdrawn due to risk of fatal complications of constipation; reintroduced 2002 on a restricted basis
cisapride 2000s Withdrawn in many countries due to risk of cardiac arrhythmias
phenylpropanolamine (Propagest, Dexatrim) 2000 Withdrawn due to risk of stroke in women under 50 years of age when taken at high doses (75mg twice daily) for weight loss.
cerivastatin 2001 Withdrawn due to risk of rhabdomyolysis
rapacuronium 2001 Withdrawn in many countries due to risk of fatal bronchospasm
rofecoxib (Vioxx) 2004 Withdrawn due to risk of myocardial infarction
mixed amphetamine salts (Adderall XR) 2005 Withdrawn in Canada due to risk of stroke. See Health Canada press release
hydromorphone extended-release (Palladone) 2005 Withdrawn due to a high risk of accidental overdose when administered with alcohol
pemoline (Cylert) 2005 Withdrawn from U.S. market because of hepatotoxicity
natalizumab (Tysabri) 2005-2006 Voluntarily withdrawn from U.S. market because of risk of Progressive multifocal leukoencephalopathy (PML). Returned to market July, 2006.



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