List of withdrawn drugs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Some drugs have been withdrawn from the market because of risks to the patients.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Drug name | Withdrawn | Remarks |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thalidomide | 1950s–1960s | Withdrawn due to risk of teratogenicity; returned to market for use in leprosy and multiple myeloma under FDA orphan drug rules |
lysergic acid diethylamide (LSD) | 1950s–1960s | Marketed as a psychiatric cure-all; withdrawn after it became widely used recreationally |
diethylstilbestrol | 1970s | Withdrawn due to risk of teratogenicity |
phenformin and buformin | 1978 | Withdrawn due to risk of lactic acidosis |
ticrynafen | 1982 | Withdrawn due to risk of hepatitis |
zimelidine | 1983 | Withdrawn worldwide due to risk of Guillain-Barré syndrome |
methaqualone | 1984 | Withdrawn due to risk of addiction and overdose |
triazolam | 1991 | Withdrawn in the United Kingdom due to risk of psychiatric adverse drug reactions.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of fenfluramine and phentermine) | 1997 | Phentermine remains on the market, dexfenfluramine and fenfluramine – later withdrawn as caused heart valve disorder |
terfenadine | 1998 | Withdrawn due to risk of cardiac arrhythmias; superseded by fexofenadine |
mibefradil | 1998 | Withdrawn due to dangerous interactions with other drugs |
troglitazone | 2000 | Withdrawn due to risk of hepatotoxicity; superseded by pioglitazone and rosiglitazone |
alosetron | 2000 | Withdrawn due to risk of fatal complications of constipation; reintroduced 2002 on a restricted basis |
cisapride | 2000s | Withdrawn in many countries due to risk of cardiac arrhythmias |
phenylpropanolamine (Propagest, Dexatrim) | 2000 | Withdrawn due to risk of stroke in women under 50 years of age when taken at high doses (75mg twice daily) for weight loss.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cerivastatin | 2001 | Withdrawn due to risk of rhabdomyolysis |
rapacuronium | 2001 | Withdrawn in many countries due to risk of fatal bronchospasm |
rofecoxib (Vioxx) | 2004 | Withdrawn due to risk of myocardial infarction |
mixed amphetamine salts (Adderall XR) | 2005 | Withdrawn in Canada due to risk of stroke.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