List of withdrawn drugs

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Some drugs have been withdrawn from the market because of risks to the patients.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.

Contents

Significant withdrawals

Drug nameWithdrawnRemarks
Thalidomide1950s–1960sWithdrawn 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Lysergic acid diethylamide (LSD)1950s–1960sMarketed as a psychiatric drug; withdrawn after it became widely used recreationally
Diethylstilbestrol1970sWithdrawn because of risk of teratogenicity
Phenformin and Buformin1978Withdrawn because of risk of lactic acidosis
Ticrynafen1982Withdrawn because of risk of hepatitis
Zimelidine1983Withdrawn worldwide because of risk of Guillain-Barré syndrome
Phenacetin1983An ingredient in "A.P.C." tablet; withdrawn because of risk of cancer and kidney disease
Methaqualone1984Withdrawn because of risk of addiction and overdose
Nomifensine (Merital)1986Withdrawn because of risk of hemolytic anemia
Triazolam1991Withdrawn in the United Kingdom because of risk of psychiatric adverse drug reactions. This drug continues to be available in the U.S.
Terodiline (Micturin)1991Prolonged QT interval
Temafloxacin1992Withdrawn in the United States because of allergic reactions and cases of hemolytic anemia, leading to three patient deaths.[1]
Flosequinan (Manoplax)1993Withdrawn in the United States because of an increased risk of hospitalization or death
Alpidem (Ananxyl)1996Withdrawn because of rare but serious hepatotoxicity.
Chlormezanone (Trancopal)1996Withdrawn because of rare but serious cases of toxic epidermal necrolysis
Fen-phen (popular combination of fenfluramine and phentermine)1997Phentermine remains on the market, dexfenfluramine and fenfluramine – later withdrawn as caused heart valve disorder
Tolrestat (Alredase)1997Withdrawn because of risk of severe hepatotoxicity
Terfenadine (Seldane, Triludan)1998Withdrawn because of risk of cardiac arrhythmias; superseded by fexofenadine
Mibefradil (Posicor)1998Withdrawn because of dangerous interactions with other drugs
Etretinate1990sRisk of birth defects; narrow therapeutic index
Tolcapone (Tasmar)1998Hepatotoxicity
Temazepam (Restoril, Euhypnos, Normison, Remestan, Tenox, Norkotral)1999Withdrawn 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)1999Arrhythmias because of interactions with other drugs
Grepafloxacin (Raxar)1999Prolonged QT interval
Levamisole (Ergamisol)1999Still used as veterinary drug; in humans was used to treat melanoma before it was withdrawn for agranulocytosis
Troglitazone (Rezulin)2000Withdrawn because of risk of hepatotoxicity; superseded by pioglitazone and rosiglitazone
Alosetron (Lotronex)2000Withdrawn because of risk of fatal complications of constipation; reintroduced 2002 on a restricted basis
Cisapride (Propulsid)2000sWithdrawn in many countries because of risk of cardiac arrhythmias
Amineptine (Survector)2000Withdrawn because of hepatotoxicity, dermatological side effects, and abuse potential.
Phenylpropanolamine (Propagest, Dexatrim)2000Withdrawn because of risk of stroke in women under 50 years of age when taken at high doses (75 mg twice daily) for weight loss.
Trovafloxacin (Trovan)2001Withdrawn because of risk of liver failure
Cerivastatin (Baycol, Lipobay)2001Withdrawn because of risk of rhabdomyolysis
Rapacuronium (Raplon)2001Withdrawn in many countries because of risk of fatal bronchospasm
Rofecoxib (Vioxx)2004Withdrawn because of risk of myocardial infarction
Co-proxamol (Distalgesic)2004Withdrawn in the UK due to overdose dangers.
mixed amphetamine salts (Adderall XR)2005Withdrawn 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)2005Withdrawn because of a high risk of accidental overdose when administered with alcohol
Thioridazine (Melleril)2005Withdrawn from U.K. market because of cardiotoxicity
Pemoline (Cylert)2005Withdrawn from U.S. market because of hepatotoxicity
Natalizumab (Tysabri)2005–2006Voluntarily withdrawn from U.S. market because of risk of Progressive multifocal leukoencephalopathy (PML). Returned to market July, 2006.
Ximelagatran (Exanta)2006Withdrawn because of risk of hepatotoxicity (liver damage).
Pergolide (Permax)2007Voluntarily withdrawn in the U.S. because of the risk of heart valve damage. Still available elsewhere.
Tegaserod (Zelnorm)2007Withdrawn because of imbalance of cardiovascular ischemic events, including heart attack and stroke. Was available through a restricted access program until April 2008.
Aprotinin (Trasylol)2007Withdrawn because of increased risk of complications or death; permanently withdrawn in 2008 except for research use
Inhaled insulin (Exubera)2007Withdrawn in the UK due to poor sales caused by national restrictions on prescribing, doubts over long term safety and too high a cost
Lumiracoxib (Prexige)2007–2008Progressively withdrawn around the world because of serious side effects, mainly liver damage
Rimonabant (Acomplia)2008Withdrawn around the world because of risk of severe depression and suicide
Efalizumab (Raptiva)2009Withdrawn because of increased risk of progressive multifocal leukoencephalopathy; to be completely withdrawn from market by June 2009
Sibutramine (Reductil/Meridia)2010Withdrawn in Europe, Australasia, Canada, and the U.S. because of increased cardiovascular risk
Gemtuzumab ozogamicin (Mylotarg)2010Withdrawn in the U.S. due to increased risks of veno-occlusive disease and based on results of a clinical trial in which it showed no benefit in acute myeloid leukemia (AML)
Propoxyphene (Darvocet/Darvon)2010Withdrawn from worldwide market because of increased risk of heart attacks and stroke.[1]
Rosiglitazone (Avandia)2010Withdrawn in Europe because of increased risk of heart attacks and death. This drug continues to be available in the U.S.
Drotrecogin alfa (Xigris)2011Withdrawn by Lily worldwide following results of the PROWESS-SHOCK study that showed lack of efficacy (not because of toxicity like other drugs that have been withdrawn).

See also

References

External links