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List of withdrawn drugs

From Wikipedia, the free encyclopedia

This list isincomplete; you can help byadding missing items.(July 2015)

Drugs or medicines may be withdrawn from commercial markets because of risks to patients, but also because of commercial reasons (e.g. lack of demand and relatively high production costs) or because it turns out that they are less effective in clinical practice than premarketing efficacy trials suggested. When risks or harms are the cause, withdrawals will usually have been prompted by unexpected adverse effects that were not detected during the early, premaketing,clinical trials, i.e. they became apparent only frompostmarketing surveillance data collected from the wider community during routine use over longer periods of time.

This list is not limited to drugs that were ever approved by specific jurisdictions. Some of them (lumiracoxib, rimonabant, tolrestat, ximelagatran, and zimeldine, for example) received marketing approval in Europe but had not yet been approved for marketing in the United States when adverse effects became clear and they were withdrawn from the market. Some drugs in this list (e.g. LSD) were never approved for marketing in the United States or Europe.

Significant withdrawals

[edit]
Drug name (INNs where available)WithdrawnCountryRemarks
Amphetamine - mixture of four salts (Adderall XR)2005CanadaWithdrawn after reports of increased risk ofstroke; reinstated after increased risk not found[1]
Alatrofloxacin2006WorldwideSerioushepatotoxicity 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Alpidem (Ananxyl)1995WorldwideNot approved in the US; withdrawn in France in 1994[4] and the rest of the world in 1995 because of rare but serioushepatotoxicity[3][5]
Alosetron (Lotronex)2000USSerious gastrointestinal adverse events;ischaemic colitis; severeconstipation;[2] reintroduced in 2002 with restricted indications and new controls[6]
Alphaxolone/Alphadolone

(Althesin)

1984France, Germany, UKAnaphylaxis, possibly due to the carrier oil

(Cremophor EL)[3]

Amineptine (Survector)1999France, USHepatotoxicity,dermatological adverse effects, andabuse potential[7]
Aminophenazone (aminopyrine)1999France, ThailandRisk ofagranulocytosis and severe acne[3]
Amobarbital1980NorwayRisk ofbarbiturate toxicity[3]
Amoproxan1970FranceDermatological and ophthalmic toxicity[3]
Anagestone acetate1969GermanyAnimal carcinogenicity[3]
Antrafenine1984FranceUnspecific experimental toxicity[3]
Aprotinin (Trasylol)2008USIncreased risk of death[2]
Ardeparin (Normiflo)2001USWithdrawn at the request of theNDA originator, "not for reason of safety or efficacy"[8][9]
Astemizole (Hismanal)1999US, Malaysia, several nonspecified marketsFatalarrhythmia[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-acetanilanide1986GermanyRenal toxicity, animal carcinogenicity[3]
Bezitramide2004NetherlandsRisk of fatal overdose[10]
Bithionol1967USDermatological 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)1964USDermatological toxicity; psychiatric reactions[3]
Canrenone1986GermanyAnimal carcinogenicity[3]
Cerivastatin (Baycol, Lipobay)2001USRisk ofrhabdomyolysis[2]
Chlormadinone (Chlormenadione)1970UK, USAnimal carcinogenicity[3]
Chlormezanone (Trancopal)1996European Union, US, South Africa, JapanHepatotoxicity andStevens–Johnson Syndrome[3]
Chlorphentermine1969GermanyCardiovascular toxicity[3]
Cianidanol1985France, Germany, Spain, SwedenHaemolytic anaemia[3]
Cinepazide1988SpainAgranulocytosis[12][13]
Cisapride (Propulsid)2000USRisk of fatalcardiac arrhythmias[2]
Clioquinol1973France, Germany, UK, USNeurotoxicity[3]
Clobutinol2007GermanyVentricular arrhythmias, QT-interval prolongation[14]
Cloforex1969GermanyCardiovascular toxicity[3]
Clomacron1982UKHepatotoxicity[3]
Clometacin1987FranceHepatotoxicity[3]
Co-proxamol (codeine + paracetamol; Distalgesic)2004UKRisk of overdose
Cyclobarbital1980NorwayRisk of overdose[3]
Cyclofenil1987FranceHepatotoxicity[3]
Dantron1963Canada, UK, USMutagenic;[15] withdrawn from general use in the 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 reactions[3]
Dilevalol1990UKHepatotoxicity[3]
Dimazole (Diamthazole)1972France, USNeuropsychiatric reactions[3]
Dimethylamylamine (DMAA)1983USVoluntarily withdrawn from market by Lilly;[17]: 12  reintroduced as adietary supplement in 2006;[17]: 13  in 2013 the FDA started work to ban it because of cardiovascular problems[18]
Dinoprostone1990UKUterine hypotonus, fetal distress[3]
Dipyrone (Metamizole)1975UK, US, othersAgranulocytosis, anaphylactic reactions[3]
Dithiazanine iodide1964France, USCardiovascular and metabolic reactions[3]
Dofetilide2004GermanyDrug-drug interactions, prolonged QT[14]
Drotrecogin alfa (Xigris)2011WorldwideLack of efficacy as shown in the PROWESS-SHOCK study[19][20][21]
Ebrotidine1998SpainHepatotoxicity[3]
Efalizumab (Raptiva)2009GermanyIncreased risk of progressive multifocal leukoencephalopathy[14]
Encainide1991UK, USVentricular arrhythmias[2][3]
Ethyl carbamate1963Canada, UK, USCarcinogen[22]
Etretinate1989FranceTeratogen[2][3]
Exifone1989FranceHepatotoxicity[3]
Fen-phen (combination offenfluramine +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 treatment of seizures associated withDravet syndrome, under FDAorphan drug rules
Fenoterol1990New ZealandIncreased asthma mortality[3]
Feprazone1984Germany, UKCutaneous reactions, 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 dysglycaemia[2]
Gemtuzumab ozogamicin (Mylotarg)2010USNo improvement in clinical benefit; risk for death;[2] returned to market in 2017[25]
Glafenine1984France, GermanyAnaphylaxis[3]
Grepafloxacin (Raxar)1999Germany, UK, US, othersCardiac repolarization; QT interval prolongation[2]
Hydromorphone (Palladone, extended release version)2005High risk of accidental overdose when extended release version (Palladone) administered withalcohol; 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 reactions[3]
Iproniazid1964CanadaInteractions with food products containing tyrosine[28]
Isaxonine phosphate1984FranceHepatotoxicity[3]
Isoxicam1983France, Germany, Spain, othersStevens–Johnson syndrome[3]
Kava kava (Piper methysticum)2002GermanyHepatotoxicity[14]
Ketorolac1993France, Germany, othersHaemorrhage,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's List of Essential Medicines; in humans, it was used to treat melanoma before it was withdrawn because ofagranulocytosis[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-drug interactions[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 ofaddiction andoverdose[33][34]
Metipranolol1990UK, othersUveitis[3]
Metofoline1965USUnspecific experimental toxicity[3]
Mibefradil1998European Union, Malaysia, US, othersFatal arrhythmias, drug-drug interactions[2][3]
Minaprine1996FranceConvulsions[3]
Moxisylyte1993FranceNecrotic hepatitis[3]
Muzolimine1987France, Germany, European UnionPolyneuropathy[3]
Natalizumab (Tysabri)2005–2006USVoluntarily withdrawn from the US market because of a risk ofProgressive multifocal leukoencephalopathy (PML); returned to the market in July 2006
Nefazodone2004Europe, Australia, New Zealand, Canada[35][36][37]Branded version withdrawn by the originator in several countries in 2007 because of hepatotoxicity; generic versions available; still available in the US
Nialamide1974UK, USHepatotoxicity, drug -drug interactions[3]
Nikethamide1988Multiple marketsCNS stimulation[3]
Nitrefazole1984GermanyHepatic and haematological toxicity[3]
Nomifensine1981–1986France, Germany, Spain, UK, US, othersHaemolytic anaemia, hepatotoxicity, serious hypersensitivity 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 of death; veno-occlusive disease[2]
Pemoline (Cylert)1997Canada, UKWithdrawn in the US in 2005 because of hepatotoxicity[41][3]
Pentobarbital1980NorwayRisk of fatal overdose[3]
Pentylenetetrazol1982USWithdrawn because of inability to produce effectiveconvulsive therapy, and because it caused seizures
Pergolide (Permax)2007USRisk of heart valve damage[2]
Perhexiline1985UK, SpainNeurological and hepatic toxicity[3]
Phenacetin1975CanadaAn ingredient in "APC" tablets (aspirin + phenacetin + caffeine); withdrawn because of risks of cancer and kidney disease[42] in Germany, Denmark, UK, US, and in others because of nephropathy[3]
Phenformin andBuformin1977France, Germany, USSeverelactic acidosis[3]
Phenolphthalein1997USPossible carcinogen[43]
Phenoxypropazine1966UKHepatotoxicity, drug-drug intereactions[3]
Phenylbutazone1985GermanyOff-label abuse, haematological toxicity[3]
Phenylpropanolamine (Propagest,Dexatrim)2000Canada, USHaemorrhagic stroke[44][45]
Pifoxime (=Pixifenide)1976FranceNeuropsychiatric reactions[3]
Pirprofen1990France, Germany, SpainLiver toxicity.[3][12]: 223 
Prenylamine1988Canada, France, Germany, UK, US, othersCardiac arrhythmias[46] and death[3]
Proglumide1989GermanyRespiratory reactions[3]
Pronethalol1965UKAnimal carcinogenicity[3]
Propanidid1983UKAllergy[3]
Proxibarbal1998Spain, France, Italy, Portugal, TurkeyImmunoallergic, thrombocytopenia[3]
Pyrovalerone1979FranceAbuse[3]
Ranitidine (Zantac)2020WorldwideFound to spontaneously break down into the carcinogenN-nitrosodimethylamine
Rapacuronium (Raplon)2001US, multiple marketsWithdrawn in many countries because of the risk of fatalbronchospasm[2]
Remoxipride1993UK, othersAplastic anaemia[3]
Rhesus rotavirus vaccine-tetravalent (RotaShield)1999USWithdrawn because of a risk ofintussusception[47]
Rimonabant (Acomplia)2008WorldwideRisk of severe depression and suicide[14]
Rofecoxib (Vioxx)2004WorldwideWithdrawn byMerck & Co. because of the risks ofmyocardial infarction and stroke[2]
Rosiglitazone (Avandia)2010EuropeRisk of heart attacks and death; still available in the US
Secobarbital1990France, Norway, others[which?]Risk of overdose[3]
Sertindole1998European UnionArrhythmias 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] US[59]Increased risk of heart attack and stroke[2]
Sitaxentan2010GermanyHepatotoxicity[14]
Sorivudine1993JapanDrug-drug interactions and deaths[60]
Sparfloxacin2001USQT interval prolongation and phototoxicity[2]
Sulfacarbamide1988GermanyDermatological, hematological, and hepatic reactions[3]
Sulfamethoxydiazine1988GermanyDermatological reactions
Sulfamethoxypyridazine1986UKDermatological and haematological reactions[3]
Suloctidil1985Germany, France, SpainHepatotoxicity[3]
Suprofen1986–1987UK, Spain, USKidney damage[2][3]
Tegaserod (Zelnorm)2007USRisks of heart attack, stroke, and unstable angina;[2] was available through a restricted access programme until April 2008; returned to the market in 2019
Temafloxacin1992Germany, UK, US, othersLow blood sugar; haemolytic anaemia; kidney, liver dysfunction; allergic reactions[2][3]
Temafloxacin1992USAllergic reactions and cases of haemolytic anaemia, leading to three deaths[2]
Temazepam (Restoril, Euhypnos, Normison, Remestan, Tenox, Norkotral)1999Sweden, NorwayDiversion, abuse, and a relatively high rate of overdose deaths compared with other drugs of its group; it is still available in most of the world, including the US, but under strict controls
Terfenadine (Seldane, Triludan)1997–1998France, South Africa, Oman, US, othersProlonged QT interval;ventricular tachycardia[2][3]
Terodiline (Micturin)1991Germany, UK, Spain, othersProlonged QT interval, ventricular tachycardia, and other arrhythmias[3]
Tetrazepam2013European UnionSerious cutaneous reactions[61]
Thalidomide1961GermanyWithdrawn because of risk ofteratogenicity;[62] returned to the market for use inleprosy andmultiple myeloma under FDAorphan drug rules
Thenalidine1963Canada, UK, USNeutropenia[3][63]
Thiobutabarbital1993GermanyKidney damage[3]
Thioridazine (Melleril)2005Germany, UKWithdrawn worldwide because of severe cardiac arrhythmias;[64][65] still 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)2000Germany, USHepatotoxicity[2]
Trovafloxacin (Trovan)1999–2001European Union, USWithdrawn because of risk ofliver failure[2][3]
Valdecoxib (Bextra)2004USRisk of heart attack and stroke[2]
Vincamine1987GermanyHaematological toxicity[3]
Xenazoic acid1965FranceHepatotoxicity[3]
Ximelagatran (Exanta)2006GermanyHepatotoxicity[14]
Zimeldine1983WorldwideRisk ofGuillain–Barré syndrome, hypersensitivity reactions, hepatotoxicity;[3][67][68] banned worldwide.[69]
Zomepirac1983UK, Germany, Spain, USAnaphylactic reactions and non-fatal allergic reactions; kidney failure[2][3]

See also

[edit]

References

[edit]
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  59. ^Rockoff, Jonathan D.; Dooren, Jennifer Corbett (October 8, 2010)."Abbott Pulls Diet Drug Meridia Off US Shelves".The Wall Street Journal.Archived from the original on 11 October 2010. Retrieved8 October 2010.
  60. ^H. Gurdon:Japan bans shingles drug after deathsArchived 2003-06-26 at theWayback Machine BMJ 1994;309:627
  61. ^Paar, W.D; Müller-Jakic."Ruhen der Zulassung Tetrazepam haltiger Arzneimittel in der EU (German)"(PDF). Sanofi-Aventis Deutschland GmbH. Archived fromthe original(PDF) on 27 September 2013. Retrieved25 September 2013.
  62. ^Luippold, Gerd (2006)."Renaissance des Contergan-Wirkstoffs".Pharmazeutische Zeitung (German).Archived from the original on 27 September 2013. Retrieved25 September 2013.
  63. ^Drugbank."Thenalidine". Archived fromthe original on 27 September 2013. Retrieved24 September 2013.
  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 fromthe original(PDF) on 2015-05-18.
  66. ^DrugBank."Triazolam". Archived fromthe original on 27 September 2013. Retrieved24 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 says "withdrawn in 1983"
  69. ^DrugBank."Zimelidine".Archived from the original on 27 September 2013. Retrieved24 September 2013.

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