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List of withdrawn drugs

From Wikipedia, the free encyclopedia

Drugs or medicines may be withdrawn from commercial markets because of risks to patients, but also because of commercial reasons (e.g. lack of demand and relatively high production costs). 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 from postmarketing 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 the FDA. 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 USA, when adverse effects became clear and their developers withdrew them from the market. Some drugs in this list (e.g. LSD) were never approved for marketing in the USA or Europe.

Significant withdrawals

[edit]
Drug name (INNs where available) Withdrawn Country Remarks
Amfetamine - mixture of four salts (Adderall XR) 2005 Canada Withdrawn after reports of increased risk of stroke, reinstated after increased risk not found[1]
Alatrofloxacin 2006 Worldwide Serious hepatotoxicity leading to liver transplant or death[2]
Alclofenac 1979 UK Vasculitis[3]
Alpidem (Ananxyl) 1995 Worldwide Not approved in the USA; withdrawn in France in 1994[4] and the rest of the world in 1995 because of rare but serious hepatotoxicity[3][5]
Alosetron (Lotronex) 2000 USA Serious gastrointestinal adverse events; ischemic colitis; severe constipation;[2] reintroduced in 2002 with restricted indications and new controls[6]
Alphaxolone/Alphadolone

(Althesin)

1984 France, Germany, UK Anaphylaxis, possibly due to the carrier oil

(Cremophor EL)[3]

Amineptine (Survector) 1999 France, USA Hepatotoxicity, dermatological adverse effects, and abuse potential[7]
Aminophenazone (aminopyrine) 1999 France, Thailand Risk of agranulocytosis and severe acne[3]
Amobarbital 1980 Norway Risk of barbiturate toxicity[3]
Amoproxan 1970 France Dermatological and ophthalmic toxicity[3]
Anagestone acetate 1969 Germany Animal carcinogenicity[3]
Antrafenine 1984 France Unspecific experimental toxicity[3]
Aprotinin (Trasylol) 2008 USA Increased risk of death[2]
Ardeparin (Normiflo) 2001 USA Withdrawn at the request of the NDA originator, "not for reason of safety or efficacy"[8][9]
Astemizole (Hismanal) 1999 USA, Malaysia, several nonspecified markets Fatal arrhythmia[2][3]
Azaribine 1976 USA Thromboembolism[3]
Bendazac 1993 Spain Hepatotoxicity[3]
Benoxaprofen (Oraflex, Opren) 1982 Germany, Spain, UK, USA Liver and kidney failure; gastrointestinal bleeding; ulcers[2][3]
Benzarone 1992 Germany Hepatitis[3]
Benziodarone 1964 France, UK Jaundice[3]
Beta-ethoxy-acetanilanide 1986 Germany Renal toxicity, animal carcinogenicity[3]
Bezitramide 2004 Netherlands Risk of fatal overdose[10]
Bithionol 1967 USA Dermatological toxicity[3]
Brotizolam 1989 UK Animal carcinogenicity[3]
Bromfenac 1998 USA Severe hepatitis and liver failure (requiring transplantation)[2]
Bucetin 1986 Germany Kidney damage[3]
Buformin 1978 Germany Metabolic toxicity[3]
Bunamiodyl 1963 Canada, UK, USA Nephropathy[11]
Butamben (Efocaine)(Butoforme) 1964 USA Dermatological toxicity; psychiatric reactions[3]
Canrenone 1986 Germany Animal carcinogenicity[3]
Cerivastatin (Baycol, Lipobay) 2001 USA Risk of rhabdomyolysis[2]
Chlormadinone (Chlormenadione) 1970 UK, USA Animal carcinogenicity[3]
Chlormezanone (Trancopal) 1996 European Union, US, South Africa, Japan Hepatotoxicity and Stevens–Johnson Syndrome[3]
Chlorphentermine 1969 Germany Cardiovascular toxicity[3]
Cianidanol 1985 France, Germany, Spain, Sweden Haemolytic anaemia[3]
Cinepazide 1988 Spain Agranulocytosis[12][13]
Cisapride (Propulsid) 2000 USA Risk of fatal cardiac arrhythmias[2]
Clioquinol 1973 France, Germany, UK, USA Neurotoxicity[3]
Clobutinol 2007 Germany Ventricular arrhythmias, QT-interval prolongation[14]
Cloforex 1969 Germany Cardiovascular toxicity[3]
Clomacron 1982 UK Hepatotoxicity[3]
Clometacin 1987 France Hepatotoxicity[3]
Co-proxamol (codeine + paracetamol; Distalgesic) 2004 UK Risk of overdose
Cyclobarbital 1980 Norway Risk of overdose[3]
Cyclofenil 1987 France Hepatotoxicity[3]
Dantron 1963 Canada, UK, USA Mutagenic;[15] withdrawn from general use in the UK but permitted in terminal patients
Dexfenfluramine 1997 European Union, UK, USA Cardiotoxic[3]
Propoxyphene (Darvocet/Darvon) 2010 Worldwide Increased risk of heart attacks and stroke[16]
Diacetoxydiphenolisatin 1971 Australia Hepatotoxicity[3]
Diethylstilbestrol 1970s USA Carcinogen
Difemerine 1986 Germany Multi-organ toxicities[3]
Dihydrostreptomycin 1970 USA Neuropsychiatric reactions[3]
Dilevalol 1990 UK Hepatotoxicity[3]
Dimazole (Diamthazole) 1972 France, USA Neuropsychiatric reactions[3]
Dimethylamylamine (DMAA) 1983 US Voluntarily withdrawn from market by Lilly;[17]: 12  reintroduced as a dietary supplement in 2006;[17]: 13  in 2013 the FDA started work to ban it because of cardiovascular problems[18]
Dinoprostone 1990 UK Uterine hypotonus, fetal distress[3]
Dipyrone (Metamizole) 1975 UK, USA, Others Agranulocytosis, anaphylactic reactions[3]
Dithiazanine iodide 1964 France, USA Cardiovascular and metabolic reactions[3]
Dofetilide 2004 Germany Drug-drug interactions, prolonged QT[14]
Drotrecogin alfa (Xigris) 2011 Worldwide Lack of efficacy as shown in the PROWESS-SHOCK study[19][20][21]
Ebrotidine 1998 Spain Hepatotoxicity[3]
Efalizumab (Raptiva) 2009 Germany Increased risk of progressive multifocal leukoencephalopathy[14]
Encainide 1991 UK, USA Ventricular arrhythmias[2][3]
Ethyl carbamate 1963 Canada, UK, USA Carcinogen[22]
Etretinate 1989 France Teratogen[2][3]
Exifone 1989 France Hepatotoxicity[3]
Fen-phen (combination of fenfluramine + phentermine) 1997 Cardiotoxicity
Fenclofenac 1984 UK Cutaneous reactions; animal carcinogenicity[3]
Fenclozic acid 1970 UK, USA Hepatotoxicity[3]
Fenfluramine 1997 European Union, UK, USA, India, South Africa, others Cardiac valvular disease, pulmonary hypertension, cardiac fibrosis;[3][23] re-approved in June 2020 for treatment of seizures associated with Dravet syndrome, under FDA orphan drug rules
Fenoterol 1990 New Zealand Increased asthma mortality[3]
Feprazone 1984 Germany, UK Cutaneous reactions, multiorgan toxicity[3]
Fipexide 1991 France Hepatotoxicity[3]
Flosequinan (Manoplax) 1993 UK, USA Increased mortality at higher doses; increased hospitalizations[2][3]
Flunitrazepam 1991 France Abuse[3]
Flupirtine 2018 European Union Liver toxicity[24]
Gatifloxacin 2006 USA Increased risk of dysglycaemia[2]
Gemtuzumab ozogamicin (Mylotarg) 2010 USA No improvement in clinical benefit; risk for death;[2] returned to market in 2017[25]
Glafenine 1984 France, Germany Anaphylaxis[3]
Grepafloxacin (Raxar) 1999 Germany, UK, USA, others Cardiac repolarization; QT interval prolongation[2]
Hydromorphone (Palladone, extended release version) 2005 High risk of accidental overdose when extended release version (Palladone) administered with alcohol; standard hydromorphone is sold in most of the world, including the USA
Ibufenac 1968 UK Hepatotoxicity, jaundice[3]
Indalpine 1985 France Agranulocytosis[3]
Indoprofen 1983 Germany, Spain, UK Animal carcinogenicity, gastrointestinal toxicity[3]
Ingenol mebutate gel 2020 Suspended in Europe Increased risk of skin cancers[26][27]
Iodinated casein strophantin 1964 USA Metabolic reactions[3]
Iproniazid 1964 Canada Interactions with food products containing tyrosine[28]
Isaxonine phosphate 1984 France Hepatotoxicity[3]
Isoxicam 1983 France, Germany, Spain, others Stevens–Johnson syndrome[3]
Kava kava (Piper methysticum) 2002 Germany Hepatotoxicity[14]
Ketorolac 1993 France, Germany, others Haemorrhage, Kidney Failure[3]
L-tryptophan 1989 Germany, UK Eosinophilic myalgia syndrome;[3] still sold in the USA
Levamisole (Ergamisol) 1999 USA Still 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 acetate 2003 USA Cardiac arrhythmias and cardiac arrest[2]
Lorcaserin (Belviq) 2020 USA Increased risk of cancer[32]
Lumiracoxib (Prexige) 2007–2008 Worldwide Liver damage
Lysergic acid diethylamide (LSD) 1950s–1960s Marketed as a psychiatric drug; withdrawn after it became widely used recreationally; now illegal in most of the world
Mebanazine 1975 UK Hepatotoxicity, drug-drug interactions[3]
Methandrostenolone 1982 France, Germany, UK, USA, others Off-label abuse[3]
Methapyrilene 1979 Germany, UK, USA Animal carcinogenicity[3]
Methaqualone 1984 South Africa (1971), India (1984), United Nations (1971–1988) Withdrawn because of risk of addiction and overdose[33][34]
Metipranolol 1990 UK, others Uveitis[3]
Metofoline 1965 USA Unspecific experimental toxicity[3]
Mibefradil 1998 European Union, Malaysia, USA, others Fatal arrhythmias, drug-drug interactions[2][3]
Minaprine 1996 France Convulsions[3]
Moxisylyte 1993 France Necrotic hepatitis[3]
Muzolimine 1987 France, Germany, European Union Polyneuropathy[3]
Natalizumab (Tysabri) 2005–2006 USA Voluntarily withdrawn from the US market because of a risk of Progressive multifocal leukoencephalopathy (PML); returned to the market in July 2006
Nefazodone 2004 Europe, 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 USA
Nialamide 1974 UK, USA Hepatotoxicity, drug -drug interactions[3]
Nikethamide 1988 Multiple markets CNS stimulation[3]
Nitrefazole 1984 Germany Hepatic and haematological toxicity[3]
Nomifensine 1981–1986 France, Germany, Spain, UK, USA, others Haemolytic anaemia, hepatotoxicity, serious hypersensitivity reactions[2][3]
Oxeladin 1976 Canada, UK, USA (1976) Carcinogen[38]
Oxyphenbutazone 1984–1985 UK, USA, Germany, France, Canada Bone marrow suppression, Stevens–Johnson syndrome[3][39][40]
Oxyphenisatin (Phenisatin) 1970s Australia, France, Germany, UK, USA Hepatotoxicity[3]
Ozogamicin 2010 USA No improvement in clinical benefit; risk of death; veno-occlusive disease[2]
Pemoline (Cylert) 1997 Canada, UK Withdrawn in the USA in 2005 because of hepatotoxicity[41][3]
Pentobarbital 1980 Norway Risk of fatal overdose[3]
Pentylenetetrazol 1982 USA Withdrawn because of inability to produce effective convulsive therapy, and because it caused seizures
Pergolide (Permax) 2007 USA Risk of heart valve damage[2]
Perhexiline 1985 UK, Spain Neurological and hepatic toxicity[3]
Phenacetin 1975 Canada An ingredient in "A.P.C." tablets (aspirin + phenacetin + caffeine); withdrawn because of risks of cancer and kidney disease[42] in Germany Denmark, UK, USA, and others because of nephropathy[3]
Phenformin and Buformin 1977 France, Germany, USA Severe lactic acidosis[3]
Phenolphthalein 1997 USA Possible carcinogen[43]
Phenoxypropazine 1966 UK Hepatotoxicity, drug-drug intereactions[3]
Phenylbutazone 1985 Germany Off-label abuse, haematological toxicity[3]
Phenylpropanolamine (Propagest, Dexatrim) 2000 Canada, USA Haemorrhagic stroke[44][45]
Pifoxime (=Pixifenide) 1976 France Neuropsychiatric reactions[3]
Pirprofen 1990 France, Germany, Spain Liver toxicity.[3][12]: 223 
Prenylamine 1988 Canada, France, Germany, UK, USA, others Cardiac arrhythmias[46] and death[3]
Proglumide 1989 Germany Respiratory reactions[3]
Pronethalol 1965 UK Animal carcinogenicity[3]
Propanidid 1983 UK Allergy[3]
Proxibarbal 1998 Spain, France, Italy, Portugal, Turkey Immunoallergic, thrombocytopenia[3]
Pyrovalerone 1979 France Abuse[3]
Ranitidine (Zantac) 2020 Worldwide Found to spontaneously break down into the carcinogen N-nitrosodimethylamine
Rapacuronium (Raplon) 2001 USA, multiple markets Withdrawn in many countries because of the risk of fatal bronchospasm[2]
Remoxipride 1993 UK, others Aplastic anaemia[3]
Rhesus rotavirus vaccine-tetravalent (RotaShield) 1999 USA Withdrawn bec ause of risk of intussusception[47]
Rimonabant (Acomplia) 2008 Worldwide Risk of severe depression and suicide[14]
Rofecoxib (Vioxx) 2004 Worldwide Withdrawn by Merck & Co. because of the risks of myocardial infarction and stroke[2]
Rosiglitazone (Avandia) 2010 Europe Risk of heart attacks and death; still available in the USA
Secobarbital 1990 France, Norway, others.[which?] Risk of overdose[3]
Sertindole 1998 European Union Arrhythmias and sudden cardiac death[3][48]
Sibutramine (Reductil/Meridia) 2010 Australia,[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 USA[59] Increased risk of heart attack and stroke[2]
Sitaxentan 2010 Germany Hepatotoxicity[14]
Sorivudine 1993 Japan Drug-drug interactions and deaths[60]
Sparfloxacin 2001 USA QT interval prolongation and phototoxicity[2]
Sulfacarbamide 1988 Germany Dermatological, hematological, and hepatic reactions[3]
Sulfamethoxydiazine 1988 Germany Dermatological reactions
Sulfamethoxypyridazine 1986 UK Dermatological and haematological reactions[3]
Suloctidil 1985 Germany, France, Spain Hepatotoxicity[3]
Suprofen 1986–1987 UK, Spain, USA Kidney damage[2][3]
Tegaserod (Zelnorm) 2007 US Risks of heart attack, stroke, and unstable angina;[2] was available through a restricted access programme until April 2008; returned to the market in 2019
Temafloxacin 1992 Germany, UK, USA, others Low blood sugar; haemolytic anaemia; kidney, liver dysfunction; allergic reactions[2][3]
Temafloxacin 1992 US Allergic reactions and cases of haemolytic anaemia, leading to three deaths[2]
Temazepam (Restoril, Euhypnos, Normison, Remestan, Tenox, Norkotral) 1999 Sweden, Norway Diversion, 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 USA, but under strict controls
Terfenadine (Seldane, Triludan) 1997–1998 France, South Africa, Oman, USA, others Prolonged QT interval; ventricular tachycardia[2][3]
Terodiline (Micturin) 1991 Germany, UK, Spain, others Prolonged QT interval, ventricular tachycardia, and other arrhythmias[3]
Tetrazepam 2013 European Union Serious cutaneous reactions[61]
Thalidomide 1961 Germany Withdrawn because of risk of teratogenicity;[62] returned to the market for use in leprosy and multiple myeloma under FDA orphan drug rules
Thenalidine 1963 Canada, UK, USA Neutropenia[3][63]
Thiobutabarbital 1993 Germany Kidney damage[3]
Thioridazine (Melleril) 2005 Germany, UK Withdrawn worldwide because of severe cardiac arrhythmias;[64][65] still available in Russia
Ticrynafen (Tienilic acid) 1980 Germany, France, UK, USA others Liver toxicity and death[3]
Tolcapone (Tasmar) 1998 European Union, Canada, Australia Hepatotoxicity[3]
Tolrestat (Alredase) 1996 Argentina, Canada, Italy, others Severe hepatotoxicity[3]
Triacetyldiphenolisatin 1971 Australia Hepatotoxicity[3]
Triazolam 1991 France, Netherlands, Finland, Argentina, UK, others Psychiatric adverse drug reactions, amnesia[3][66]
Triparanol 1962 France, USA Cataracts, alopecia, ichthyosis[3]
Troglitazone (Rezulin) 2000 US, Germany Hepatotoxicity[2]
Trovafloxacin (Trovan) 1999–2001 European Union, USA Withdrawn because of risk of liver failure[2][3]
Valdecoxib (Bextra) 2004 USA Risk of heart attack and stroke[2]
Vincamine 1987 Germany Haematological toxicity[3]
Xenazoic acid 1965 France Hepatotoxicity[3]
Ximelagatran (Exanta) 2006 Germany Hepatotoxicity[14]
Zimeldine 1983 Worldwide Risk of Guillain–Barré syndrome, hypersensitivity reactions, hepatotoxicity;[3][67][68] banned worldwide.[69]
Zomepirac 1983 UK, Germany, Spain, USA Anaphylactic reactions and non-fatal allergic reactions; kidney failure[2][3]

See also

[edit]

References

[edit]
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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.
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