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List of withdrawn drugs

Drugs or medicines may be withdrawn from commercial markets because of risks to patients, but also because of commercial reasons (e.g. lack of demand and relatively high production costs). Where risks or harms is the reason for withdrawal, this will usually have been prompted by unexpected adverse effects that were not detected during Phase III clinical trials, i.e. they were only made apparent from postmarketing surveillance data collected from the wider community over longer periods of time.

This list is not limited to drugs that were ever approved by the FDA. Some of them (lumiracoxib, rimonabant, tolrestat, ximelagatran and ximelidine, for example) were approved to be marketed in Europe but had not yet been approved for marketing in the US, when side effects became clear and their developers pulled them from the market. Some drugs in this list (e.g. LSD) were never approved for marketing in the US or Europe.

Significant withdrawals

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Drug nameWithdrawnCountryRemarks
Amphetamine Mix (Adderall XR)2005CanadaWithdrawn over reports of increased risk of stroke, reinstated after increased risk not found.[1]
Alatrofloxacin2006WorldwideSerious hepatotoxicity leading to liver transplant or death.[2]
Alclofenac1979UKVasculitis[3]
Alpidem (Ananxyl)1995WorldwideNot approved in the US, withdrawn in France in 1994[4] and the rest of the market in 1995 because of rare but serious hepatotoxicity.[3][5]
Alosetron (Lotronex)2000USSerious gastrointestinal adverse events; ischemic colitis; severe constipation.[2] Reintroduced 2002 with restricted indication and new controls.[6]
Alphaxolone/Alphadolone (Althesin)1984France, Germany, UKAnaphylaxis, possibly due to carrier oil (Cremophor EL).[3]
Amineptine (Survector)1999France, USHepatotoxicity, dermatological side effects, and abuse potential.[7]
Aminopyrine1999France, ThailandRisk of agranulocytosis and severe acne.[3]
Amobarbital1980NorwayRisk of barbiturate toxicity.[3]
Amoproxan1970FranceDermatologic and ophthalmic toxicity.[3]
Anagestone acetate1969GermanyAnimal carcinogenicity.[3]
Antrafenine1984FranceUnspecific experimental toxicity.[3]
Aprotinin (Trasylol)2008USIncreased risk of death.[2]
Ardeparin (Normiflo)2001USWithdrawn at request of NDA originator, "not for reason of safety or efficacy."[8][9]
Astemizole (Hismanal)1999US, Malaysia, Multiple Nonspecified MarketsFatal arrhythmia[2][3]
Azaribine1976USThromboembolism.[3]
Bendazac1993SpainHepatotoxicity.[3]
Benoxaprofen (Oraflex, Opren)1982Germany, Spain, UK, USLiver and kidney failure; gastrointestinal bleeding; ulcers.[2][3]
Benzarone1992GermanyHepatitis.[3]
Benziodarone1964France, UKJaundice.[3]
Beta-ethoxy-lacetanilanide1986GermanyRenal toxicity, animal carcinogenicity.[3]
Bezitramide2004NetherlandsRisk of fatal overdose[10]
Bithionol1967USDermatologic toxicity.[3]
Brotizolam1989UKAnimal carcinogenicity.[3]
Bromfenac1998USSevere hepatitis and liver failure (requiring transplantation).[2]
Bucetin1986GermanyKidney damage[3]
Buformin1978GermanyMetabolic toxicity.[3]
Bunamiodyl1963Canada, UK, USNephropathy.[11]
Butamben (Efocaine)(Butoforme)1964USDermatologic toxicity; psychiatric reactions.[3]
Canrenone1986GermanyAnimal Carcinogenicity.[3]
Cerivastatin (Baycol, Lipobay)2001USRisk of rhabdomyolysis[2]
Chlormadinone (Chlormenadione)1970UK, USAnimal Carcinogenicity.[3]
Chlormezanone (Trancopal)1996European Union, US, South Africa, JapanHepatotoxicity and Stevens–Johnson Syndrome[3]
Chlorphentermine1969GermanyCardiovascular Toxicity.[3]
Cianidanol1985France, Germany, Spain, SwedenHemolytic Anemia.[3]
Cinepazide1988SpainAgranulocytosis.[12][13]
Cisapride (Propulsid)2000USRisk of fatal cardiac arrhythmias[2]
Clioquinol1973France, Germany, UK, USNeurotoxicity.[3]
Clobutinol2007GermanyVentricular arrhythmia, QT-prolongation.[14]
Cloforex1969GermanyCardiovascular toxicity.[3]
Clomacron1982UKHepatotoxicity.[3]
Clometacin1987FranceHepatotoxicity.[3]
Co-proxamol (Distalgesic)2004UKRisk of overdose
Cyclobarbital1980NorwayRisk of overdose[3]
Cyclofenil1987FranceHepatotoxicity.[3]
Dantron1963Canada, UK, USMutagenic.[15] withdrawn from general use in UK but permitted in terminal patients
Dexfenfluramine1997European Union, UK, USCardiotoxic[3]
Propoxyphene (Darvocet/Darvon)2010WorldwideIncreased risk of heart attacks and stroke.[16]
Diacetoxydiphenolisatin1971AustraliaHepatotoxicity.[3]
Diethylstilbestrol1970sUSCarcinogen
Difemerine1986GermanyMulti-Organ toxicities.[3]
Dihydrostreptomycin1970USNeuropsychiatric reaction.[3]
Dilevalol1990UKHepatotoxicity.[3]
Dimazole (Diamthazole)1972France, USNeuropsychiatric reaction.[3]
Dimethylamylamine (DMAA)1983USVoluntarily withdrawn from market by Lily.[17]: 12  Reintroduced as a dietary supplement in 2006;[17]: 13  in 2013 the FDA started work to ban it due to cardiovascular problems[18]
Dinoprostone1990UKUterine hypotonus, fetal distress.[3]
Dipyrone (Metamizole)1975UK, US, OthersAgranulocytosis, anaphylactic reactions.[3]
Dithiazanine iodide1964France, USCardiovascular and metabolic reaction.[3]
Dofetilide2004GermanyDrug interactions, prolonged QT.[14]
Drotrecogin alfa (Xigris)2011WorldwideLack of efficacy as shown by PROWESS-SHOCK study[19][20][21]
Ebrotidine1998SpainHepatotoxicity.[3]
Efalizumab (Raptiva)2009GermanyWithdrawn because of increased risk of progressive multifocal leukoencephalopathy[14]
Encainide1991UK, USVentricular arrhythmias.[2][3]
Ethyl carbamate1963Canada, UK, USCarcinogen.[22]
Etretinate1989FranceTeratogen.[2][3]
Exifone1989FranceHepatotoxicity.[3]
Fen-phen (popular combination of fenfluramine and phentermine)1997Cardiotoxicity
Fenclofenac1984UKCutaneous reactions; animal carcinogenicity.[3]
Fenclozic acid1970UK, USHepatotoxicity.[3]
Fenfluramine1997European Union, UK, US, India, South Africa, othersCardiac valvular disease, pulmonary hypertension, cardiac fibrosis;[3][23] re-approved in June 2020 for the treatment of seizures associated with Dravet syndrome, under FDA orphan drug rules.
Fenoterol1990New ZealandAsthma mortality.[3]
Feprazone1984Germany, UKCutaneous reaction, multiorgan toxicity.[3]
Fipexide1991FranceHepatotoxicity.[3]
Flosequinan (Manoplax)1993UK, USIncreased mortality at higher doses; increased hospitalizations.[2][3]
Flunitrazepam1991FranceAbuse.[3]
Flupirtine2018European UnionLiver toxicity.[24]
Gatifloxacin2006USIncreased risk of dysglycemia.[2]
Gemtuzumab ozogamicin (Mylotarg)2010USNo improvement in clinical benefit; risk for death.[2] Returned to market in 2017.[25]
Glafenine1984France, GermanyAnaphylaxis.[3]
Grepafloxacin (Raxar)1999Withdrawn Germany, UK, US othersCardiac repolarization; QT interval prolongation.[2]
Hydromorphone (Palladone, extended release version)2005High risk of accidental overdose when extended release version (Palladone) administered with alcohol. Standard hydromorphone is sold in most of the world including the US
Ibufenac1968UKHepatotoxicity, jaundice.[3]
Indalpine1985FranceAgranulocytosis.[3]
Indoprofen1983Germany, Spain, UKAnimal carcinogenicity, gastrointestinal toxicity.[3]
Ingenol mebutate gel2020Suspended in EuropeIncreased risk of skin cancers.[26][27]
Iodinated casein strophantin1964USMetabolic reaction.[3]
Iproniazid1964CanadaInteractions with food products containing tyrosine.[28]
Isaxonine phosphate1984FranceHepatotoxicity.[3]
Isoxicam1983France, Germany, Spain, othersStevens–Johnson syndrome.[3]
Kava Kava2002GermanyHepatotoxicity.[14]
Ketorolac1993France, Germany, othersHemorrhage, Kidney Failure.[3]
L-tryptophan1989Germany, UKEosinophilic myalgia syndrome.[3] Still sold in the US
Levamisole (Ergamisol)1999USStill used as veterinary drug and as a human antihelminthic in many markets; listed on the WHO List of Essential Medicines. In humans, it was used to treat melanoma before it was withdrawn for agranulocytosis.[29][30][31]
Levomethadyl acetate2003USCardiac arrhythmias and cardiac arrest.[2]
Lorcaserin (Belviq)2020USIncreased risk of cancer.[32]
Lumiracoxib (Prexige)2007–2008WorldwideLiver damage
Lysergic acid diethylamide (LSD)1950s–1960sMarketed as a psychiatric drug; withdrawn after it became widely used recreationally. Now illegal in most of the world.
Mebanazine1975UKHepatotoxicity, drug intereaction.[3]
Methandrostenolone1982France, Germany, UK, US, othersOff-label abuse.[3]
Methapyrilene1979Germany, UK, USAnimal carcinogenicity.[3]
Methaqualone1984South Africa (1971), India (1984), United Nations (1971–1988)Withdrawn because of risk of addiction and overdose[33][34]
Metipranolol1990UK, othersUveitis.[3]
Metofoline1965USUnspecific experimental toxicity.[3]
Mibefradil1998European Union, Malaysia, US, othersFatal arrhythmia, drug interactions.[2][3]
Minaprine1996FranceConvulsions.[3]
Moxisylyte1993FranceNecrotic hepatitis.[3]
Muzolimine1987France, Germany, European UnionPolyneuropathy.[3]
Natalizumab (Tysabri)2005–2006USVoluntarily withdrawn from US market because of risk of Progressive multifocal leukoencephalopathy (PML). Returned to market July 2006.
Nefazodone2004Europe, Australia, New Zealand and Canada[35][36][37]Branded version withdrawn by originator in several countries in 2007 for hepatotoxicity. Generic versions available. Still available in US market.
Nialamide1974UK, USHepatotoxicity, drug intereaction.[3]
Nikethamide1988multiple marketsCNS Stimulation.[3]
Nitrefazole1984GermanyHepatic and hematologic toxicity.[3]
Nomifensine1981–1986France, Germany, Spain, UK, US, othersHemolytic Anemia, hepatotoxicity, serious hypersensitive reactions.[2][3]
Oxeladin1976Canada, UK, US (1976)Carcinogen.[38]
Oxyphenbutazone1984–1985UK, US, Germany, France, CanadaBone marrow suppression, Stevens–Johnson syndrome.[3][39][40]
Oxyphenisatin (Phenisatin)1970sAustralia, France, Germany, UK, USHepatotoxicity.[3]
Ozogamicin2010USNo improvement in clinical benefit; risk for death; veno-occlusive disease.[2]
Pemoline (Cylert)1997Canada, UKWithdrawn from US in 2005 due to hepatotoxicity.[41][3]
Pentobarbital1980NorwayRisk of fatal overdose.[3]
Pentylenetetrazol1982USWithdrawn for inability to produce effective convulsive therapy, and for causing seizures.
Pergolide (Permax)2007USRisk for heart valve damage.[2]
Perhexiline1985UK, SpainNeurologic and hepatic toxicity.[3]
Phenacetin1975CanadaAn ingredient in "A.P.C." tablet; withdrawn because of risk of cancer and kidney disease[42] Germany Denmark, UK, US, others Reason: nephropathy.[3]
Phenformin and Buformin1977France, Germany USSevere lactic acidosis[3]
Phenolphthalein1997USPossible carcinogen.[43]
Phenoxypropazine1966UKHepatotoxicity, drug intereaction.[3]
Phenylbutazone1985GermanyOff-label abuse, hematologic toxicity.[3]
Phenylpropanolamine (Propagest, Dexatrim)2000Canada, USHemorrhagic stroke.[44][45]
Pifoxime (=Pixifenide)1976FranceNeuropsychiatric reaction.[3]
Pirprofen1990France, Germany, SpainLiver toxicity.[3][12]: 223 
Prenylamine1988Canada, France, Germany, UK, US, othersCardiac arrythmia[46] and death.[3]
Proglumide1989GermanyRespiratory reaction.[3]
Pronethalol1965UKAnimal carcinogenicity.[3]
Propanidid1983UKAllergy.[3]
Proxibarbal1998Spain, France, Italy, Portugal, TurkeyImmunoallergic, thrombocytopenia.[3]
Pyrovalerone1979FranceAbuse.[3]
Ranitidine (Zantac)2020WorldwideFound to spontaneously break down into the carcinogen N-nitrosodimethylamine.
Rapacuronium (Raplon)2001US, multiple marketsWithdrawn in many countries because of risk of fatal bronchospasm.[2]
Remoxipride1993UK, othersAplastic anemia.[3]
rhesus rotavirus vaccine-tetravalent (RotaShield)1999USWithdrawn due to risk of intussusception.[47]
Rimonabant (Acomplia)2008WorldwideRisk of severe depression and suicide.[14]
Rofecoxib (Vioxx)2004WorldwideWithdrawn by Merck & Co. Risk of myocardial infarction and stroke.[2]
Rosiglitazone (Avandia)2010EuropeRisk of heart attacks and death. This drug continues to be available in the US
SecobarbitalFrance, Norway, others.Risk of overdose[3]
Sertindole1998European UnionArrhythmia and sudden cardiac death[3][48]
Sibutramine (Reductil/Meridia)2010Australia,[49] Canada,[50] China,[51] the European Union (EU),[52] Hong Kong,[53] India,[54] Mexico, New Zealand,[55] the Philippines,[56] Thailand,[57] the United Kingdom,[58] and the United States[59]Increased risk of heart attack and stroke.[2]
Sitaxentan2010GermanyHepatotoxicity.[14]
Sorivudine1993JapanDrug interaction and deaths.[60]
Sparfloxacin2001USQT prolongation and phototoxicity.[2]
Sulfacarbamide1988GermanyDermatologic, hematologic and hepatic reactions.[3]
Sulfamethoxydiazine1988GermanyUnknown.[3]
Sulfamethoxypyridazine1986UKDermatologic and hematologic reactions.[3]
Suloctidil1985Germany, France, SpainHepatotoxicity.[3]
Suprofen1986–1987UK, Spain, USKidney damage.[2][3]
Tegaserod (Zelnorm)2007USRisk for heart attack, stroke, and unstable angina.[2] Was available through a restricted access program until April 2008; returned to market in 2019.
Temafloxacin1992Germany, UK, US, othersLow blood sugar; hemolytic anemia; kidney, liver dysfunction; allergic reactions[2][3]
Temafloxacin1992USAllergic reactions and cases of hemolytic anemia, leading to three patient deaths.[2]
Temazepam (Restoril, Euhypnos, Normison, Remestan, Tenox, Norkotral)1999Sweden, NorwayDiversion, 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 US, but under strict controls.
Terfenadine (Seldane, Triludan)1997–1998France, South Africa, Oman, others, USProlonged QT interval; ventricular tachycardia[2][3]
Terodiline (Micturin)1991Germany, UK, Spain, othersProlonged QT interval, ventricular tachycardia and arrhythmia.[3]
Tetrazepam2013European UnionSerious cutaneous reactions.[61]
Thalidomide1961GermanyWithdrawn because of risk of teratogenicity;[62] returned to market for use in leprosy and multiple myeloma under FDA orphan drug rules
Thenalidine1963Canada, UK, USNeutropenia[3][63]
Thiobutabarbitone1993GermanyKidney injury.[3]
Thioridazine (Melleril)2005Germany, UKWithdrawn worldwide due to severe cardiac arrhythmias[64][65] Continues to be available in Russia.
Ticrynafen (Tienilic acid)1980Germany, France, UK, US othersLiver toxicity and death.[3]
Tolcapone (Tasmar)1998European Union, Canada, AustraliaHepatotoxicity[3]
Tolrestat (Alredase)1996Argentina, Canada, Italy, othersSevere hepatotoxicity[3]
Triacetyldiphenolisatin1971AustraliaHepatotoxicity.[3]
Triazolam1991France, Netherlands, Finland, Argentina, UK othersPsychiatric adverse drug reactions, amnesia.[3][66]
Triparanol1962France, USCataracts, alopecia, ichthyosis.[3]
Troglitazone (Rezulin)2000US, GermanyHepatotoxicity[2]
Trovafloxacin (Trovan)1999–2001European Union, USWithdrawn because of risk of liver failure[2][3]
Valdecoxib (Bextra)2004USRisk of heart attack and stroke.[2]
Vincamine1987GermanyHematologic toxicity.[3]
Xenazoic acid1965FranceHepatotoxicity.[3]
Ximelagatran (Exanta)2006GermanyHepatotoxicity[14]
Zimelidine1983WorldwideRisk of Guillain–Barré syndrome, hypersensitivity reaction, hepatotoxicity[3][67][68] banned worldwide.[69]
Zomepirac1983UK, Germany, Spain, USAnaphylactic reactions and non-fatal allergic reactions, kidney failure[2][3]

Withdrawn clinical trial drugs

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See also

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References

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  64. ^ Purhonen, M; Koponen, H; Tiihonen, J; Tanskanen, A (November 2012). "Outcome of patients after market withdrawal of thioridazine: A retrospective analysis in a nationwide cohort". Pharmacoepidemiology and Drug Safety. 21 (11): 1227–1231. doi:10.1002/pds.3346. PMID 22941581. S2CID 19560432.
  65. ^ "SHARED CARE PROTOCOL Thioridazine" (PDF). NHS Lothian Joint Formulary. March 2012. Archived from the original (PDF) on 2015-05-18.
  66. ^ DrugBank. "Triazolam". Archived from the original on 27 September 2013. Retrieved 24 September 2013.
  67. ^ Fagius, J.; Osterman, P. O.; Sidén, A.; Wiholm, B. E. (1985). "Guillain-Barré syndrome following zimeldine treatment". Journal of Neurology, Neurosurgery, and Psychiatry. 48 (1): 65–69. doi:10.1136/jnnp.48.1.65. PMC 1028185. PMID 3156214.
  68. ^ Pubchem record Archived 2015-06-10 at the Wayback Machine says "withdrawn in 1983"
  69. ^ DrugBank. "Zimelidine". Archived from the original on 27 September 2013. Retrieved 24 September 2013.
  70. ^ Sachin Bhagchandani, Jeremiah A.Johnson, and Darrell J.Irvine (2021). "Evolution of Toll-like receptor 7/8 agonist therapeutics and their delivery approaches: From antiviral formulations to vaccine adjuvants". Advanced Drug Delivery Reviews. 175: 113803. doi:10.1016/j.addr.2021.05.013. PMC 9003539. PMID 34058283.{{cite journal}}: CS1 maint: multiple names: authors list (link)
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