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Some drugs have been withdrawn from the market because of risks to the patients.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 postmarketing surveillance data from the wider patient community.

This list is not limited to drugs that were ever approved by the FDA. Some of them (Lumiracoxib, Rimonabant, Tolrestat, Ximelagatran and Zimelidine, for example) were approved to be marketed in Europe but had not yet been approved for marketing in the U.S., when side effects became clear and their developers pulled them from the market. Likewise LSD was never approved for marketing in the U.S.

Significant withdrawals

Drug name Withdrawn Remarks
Thalidomide 1950s–1960s Withdrawn because of risk of teratogenicity; returned to market for use in leprosy and multiple myeloma under FDA orphan drug rules
Lysergic acid diethylamide (LSD) 1950s–1960s Marketed as a psychiatric cure-all; withdrawn after it became widely used recreationally
Diethylstilbestrol 1970s Withdrawn because of risk of teratogenicity
Phenformin and Buformin 1978 Withdrawn because of risk of lactic acidosis
Ticrynafen 1982 Withdrawn because of risk of hepatitis
Zimelidine 1983 Withdrawn worldwide because of risk of Guillain-Barré syndrome
Phenacetin 1983 An ingredient in "A.P.C." tablet; withdrawn because of risk of cancer and kidney disease
Methaqualone 1984 Withdrawn because of risk of addiction and overdose
Nomifensine (Merital) 1986 Withdrawn because of risk of hemolytic anemia
Triazolam 1991 Withdrawn in the United Kingdom because of risk of psychiatric adverse drug reactions.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Temafloxacin 1992 Withdrawn in the United States because of allergic reactions and cases of hemolytic anemia, leading to three patient deaths.[1]
Flosequinan (Manoplax) 1993 Withdrawn in the United States because of an increased risk of hospitalization or death
Alpidem (Ananxyl) 1996 Withdrawn because of rare but serious hepatotoxicity.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of fenfluramine and phentermine) 1997 Phentermine remains on the market, dexfenfluramine and fenfluramine – later withdrawn as caused heart valve disorder
Tolrestat (Alredase) 1997 Withdrawn because of risk of severe hepatotoxicity
Terfenadine (Seldane) 1998 Withdrawn because of risk of cardiac arrhythmias; superseded by fexofenadine
Mibefradil (Posicor) 1998 Withdrawn because of dangerous interactions with other drugs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 most of the world including the U.S., but under strict controls.
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 (Adderall XR) 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 (Palladone) 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

External links

CDER Report to the Nation: 2005 Has a list of U.S. withdrawals through 2005 [Link no longer active]








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