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
| Drug name |
Withdrawn |
Remarks |
| Thalidomide |
1950s–1960s |
Withdrawn because of risk of teratogenicity; returned to market for use in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Marketed as a psychiatric cure-all; withdrawn after it became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Withdrawn because of risk of teratogenicity |
| Phenformin and Buformin |
1978 |
Withdrawn because of risk of lactic
acidosis |
| Ticrynafen |
1982 |
Withdrawn because of risk of hepatitis |
| Zimelidine |
1983 |
Withdrawn worldwide because of risk of Guillain-Barré syndrome |
| Phenacetin |
1983 |
An ingredient in "A.P.C." tablet; withdrawn because of risk of
cancer and kidney disease |
| Methaqualone |
1984 |
Withdrawn because of risk of addiction
and overdose |
| Nomifensine (Merital) |
1986 |
Withdrawn because of risk of hemolytic anemia |
| Triazolam |
1991 |
Withdrawn in the United Kingdom because of risk of psychiatric adverse drug reactions. This
drug continues to be available in the U.S. |
| Temafloxacin |
1992 |
Withdrawn in the United States because of allergic reactions
and cases of hemolytic anemia,
leading to three patient deaths.[88807] |
| Flosequinan (Manoplax) |
1993 |
Withdrawn in the United States because of an increased risk of
hospitalization or death |
| Alpidem (Ananxyl) |
1996 |
Withdrawn because of rare but serious hepatotoxicity. |
| Fen-phen (popular combination of
fenfluramine and phentermine) |
1997 |
Phentermine remains on the market, dexfenfluramine and fenfluramine – later
withdrawn as caused heart valve
disorder |
| Tolrestat (Alredase) |
1997 |
Withdrawn because of risk of severe hepatotoxicity |
| Terfenadine (Seldane) |
1998 |
Withdrawn because of risk of cardiac arrhythmias; superseded by
fexofenadine |
| Mibefradil (Posicor) |
1998 |
Withdrawn because of dangerous interactions with other
drugs |
| Etretinate |
1990s |
Risk of birth defects; narrow therapeutic index |
| Temazepam (Restoril, Euhypnos,
Normison, Remestan, Tenox, Norkotral) |
1999 |
Withdrawn in Sweden and Norway because of
diversion, abuse, and a relatively high rate of overdose deaths in
comparison to other drugs of its group. This drug continues
to be available in the U.S. |
| Astemizole (Hismanal) |
1999 |
Arrhythmias because of interactions with other drugs |
| Troglitazone (Rezulin) |
2000 |
Withdrawn because of risk of hepatotoxicity; superseded by pioglitazone and rosiglitazone |
| Alosetron (Lotronex) |
2000 |
Withdrawn because of risk of fatal complications of constipation; reintroduced 2002 on a restricted
basis |
| Cisapride (Propulsid) |
2000s |
Withdrawn in many countries because of risk of cardiac arrhythmias |
| Amineptine (Survector) |
2000 |
Withdrawn because of hepatotoxicity, dermatological side effects, and abuse potential. |
| Phenylpropanolamine
(Propagest, Dexatrim) |
2000 |
Withdrawn because of risk of stroke in
women under 50 years of age when taken at high doses (75mg twice
daily) for weight loss. |
| Trovafloxacin (Trovan) |
2001 |
Withdrawn because of risk of liver
failure |
| cerivastatin (Baycol, Lipobay) |
2001 |
Withdrawn because of risk of rhabdomyolysis |
| Rapacuronium (Raplon) |
2001 |
Withdrawn in many countries because of risk of fatal bronchospasm |
| Rofecoxib (Vioxx) |
2004 |
Withdrawn because of risk of myocardial infarction |
| mixed amphetamine salts |
2005 |
Withdrawn in Canada because of
risk of stroke. See Health Canada press release. The ban was later
lifted because the death rate among those taking Adderall XR was
determined to be no greater than those not taking Adderall. |
| hydromorphone
extended-release |
2005 |
Withdrawn because of 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. |
| Ximelagatran (Exanta) |
2006 |
Withdrawn because of risk of hepatotoxicity (liver damage). |
| Pergolide (Permax) |
2007 |
Voluntarily withdrawn in the U.S. because of the risk of
heart valve damage. Still available
elsewhere. |
| Tegaserod (Zelnorm) |
2007 |
Withdrawn because of imbalance of cardiovascular ischemic
events, including heart attack and stroke. Was available through a
restricted access program until April 2008. |
| Aprotinin (Trasylol) |
2007 |
Withdrawn because of increased risk of complications or death;
permanently withdrawn in 2008 except for research use |
| Lumiracoxib |
2007-2008 |
Progressively withdrawn around the world because of serious
side effects, mainly liver damage |
| Rimonabant (Accomplia) |
2008 |
Withdrawn around the world because of risk of severe depression
and suicide |
| Efalizumab (Raptiva) |
2009 |
Withdrawn because of increased risk of progressive multifocal
leukoencephalopathy; to be completely withdrawn from market by June
2009 |
Has a list of
U.S. withdrawals through 2005 [
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