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List of withdrawn drugs

Drugs or medicines may be withdrawn from commercial markets because of risks to patients, but also because of commercial reasons (e.g. lack of demand and relatively high production costs).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Drug name Withdrawn Country Remarks
Amphetamine Mix (Adderall XR) 2005 Canada Withdrawn over reports of increased risk of stroke, reinstated after increased risk not found.[1]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Alpidem (Ananxyl) 1995 Worldwide Not approved in the US, withdrawn in France in 1994[4] and the rest of the market in 1995 because of rare but serious hepatotoxicity.[3][5]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) 2000 US Serious gastrointestinal adverse events; ischemic colitis; severe constipation.[2] Reintroduced 2002 with restricted indication and new controls.[6]
Alphaxolone/Alphadolone (Althesin) 1984 France, Germany, UK Anaphylaxis, possibly due to carrier oil (Cremophor EL).[3]
Amineptine (Survector) 1999 France, US Hepatotoxicity, dermatological side effects, and abuse potential.[7]
Aminopyrine 1999 France, Thailand Risk of agranulocytosis and severe acne.[3]
Amobarbital 1980 Norway Risk of barbiturate toxicity.[3]
Amoproxan 1970 France Dermatologic and ophthalmic toxicity.[3]
Anagestone acetate 1969 Germany Animal carcinogenicity.[3]
Antrafenine 1984 France Unspecific experimental toxicity.[3]
Aprotinin (Trasylol) 2008 US Increased risk of death.[2]
Ardeparin (Normiflo) 2001 US Withdrawn at request of NDA originator, "not for reason of safety or efficacy."[8][9]
Astemizole (Hismanal) 1999 US, Malaysia, Multiple Nonspecified Markets Fatal arrhythmia[2][3]
Azaribine 1976 US Thromboembolism.[3]
Bendazac 1993 Spain Hepatotoxicity.[3]
Benoxaprofen (Oraflex, Opren) 1982 Germany, Spain, UK, US Liver and kidney failure; gastrointestinal bleeding; ulcers.[2][3]
Benzarone 1992 Germany Hepatitis.[3]
Benziodarone 1964 France, UK Jaundice.[3]
Beta-ethoxy-lacetanilanide 1986 Germany Renal toxicity, animal carcinogenicity.[3]
Bezitramide 2004 Netherlands Risk of fatal overdose[10]
Bithionol 1967 US Dermatologic toxicity.[3]
Brotizolam 1989 UK Animal carcinogenicity.[3]
Bromfenac 1998 US Severe hepatitis and liver failure (requiring transplantation).[2]
Bucetin 1986 Germany Kidney damage[3]
Buformin 1978 Germany Metabolic toxicity.[3]
Bunamiodyl 1963 Canada, UK, US Nephropathy.[11]
Butamben (Efocaine)(Butoforme) 1964 US Dermatologic toxicity; psychiatric reactions.[3]
Canrenone 1986 Germany Animal Carcinogenicity.[3]
Cerivastatin (Baycol, Lipobay) 2001 US Risk of rhabdomyolysis[2]
Chlormadinone (Chlormenadione) 1970 UK, US 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 Hemolytic Anemia.[3]
Cinepazide 1988 Spain Agranulocytosis.[12][13]
Cisapride (Propulsid) 2000 US Risk of fatal cardiac arrhythmias[2]
Clioquinol 1973 France, Germany, UK, US Neurotoxicity.[3]
Clobutinol 2007 Germany Ventricular arrhythmia, QT-prolongation.[14]
Cloforex 1969 Germany Cardiovascular toxicity.[3]
Clomacron 1982 UK Hepatotoxicity.[3]
Clometacin 1987 France Hepatotoxicity.[3]
Co-proxamol (Distalgesic) 2004 UK Risk of overdose
Cyclobarbital 1980 Norway Risk of overdose[3]
Cyclofenil 1987 France Hepatotoxicity.[3]
Dantron 1963 Canada, UK, US Mutagenic.[15] withdrawn from general use in UK but permitted in terminal patients
Dexfenfluramine 1997 European Union, UK, US Cardiotoxic[3]
Propoxyphene (Darvocet/Darvon) 2010 Worldwide Increased risk of heart attacks and stroke.[16]
Diacetoxydiphenolisatin 1971 Australia Hepatotoxicity.[3]
Diethylstilbestrol 1970s US Carcinogen
Difemerine 1986 Germany Multi-Organ toxicities.[3]
Dihydrostreptomycin 1970 US Neuropsychiatric reaction.[3]
Dilevalol 1990 UK Hepatotoxicity.[3]
Dimazole (Diamthazole) 1972 France, US Neuropsychiatric reaction.[3]
Dimethylamylamine (DMAA) 1983 US Voluntarily 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]
Dinoprostone 1990 UK Uterine hypotonus, fetal distress.[3]
Dipyrone (Metamizole) 1975 UK, US, Others Agranulocytosis, anaphylactic reactions.[3]
Dithiazanine iodide 1964 France, US Cardiovascular and metabolic reaction.[3]
Dofetilide 2004 Germany Drug interactions, prolonged QT.[14]
Drotrecogin alfa (Xigris) 2011 Worldwide Lack of efficacy as shown by PROWESS-SHOCK study[19][20][21]
Ebrotidine 1998 Spain Hepatotoxicity.[3]
Efalizumab (Raptiva) 2009 Germany Withdrawn because of increased risk of progressive multifocal leukoencephalopathy[14]
Encainide 1991 UK, US Ventricular arrhythmias.[2][3]
Ethyl carbamate 1963 Canada, UK, US Carcinogen.[22]
Etretinate 1989 France Teratogen.[2][3]
Exifone 1989 France Hepatotoxicity.[3]
Fen-phen (popular combination of fenfluramine and phentermine) 1997 Cardiotoxicity
Fenclofenac 1984 UK Cutaneous reactions; animal carcinogenicity.[3]
Fenclozic acid 1970 UK, US Hepatotoxicity.[3]
Fenfluramine 1997 European Union, UK, US, India, South Africa, others Cardiac 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.
Fenoterol 1990 New Zealand Asthma mortality.[3]
Feprazone 1984 Germany, UK Cutaneous reaction, multiorgan toxicity.[3]
Fipexide 1991 France Hepatotoxicity.[3]
Flosequinan (Manoplax) 1993 UK, US Increased mortality at higher doses; increased hospitalizations.[2][3]
Flunitrazepam 1991 France Abuse.[3]
Flupirtine 2018 European Union Liver toxicity.[24]
Gatifloxacin 2006 US Increased risk of dysglycemia.[2]
Gemtuzumab ozogamicin (Mylotarg) 2010 US No improvement in clinical benefit; risk for death.[2] Returned to market in 2017.[25]
Glafenine 1984 France, Germany Anaphylaxis.[3]
Grepafloxacin (Raxar) 1999 Withdrawn Germany, UK, US 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 US
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 US Metabolic reaction.[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 2002 Germany Hepatotoxicity.[14]
Ketorolac 1993 France, Germany, others Hemorrhage, Kidney Failure.[3]
L-tryptophan 1989 Germany, UK Eosinophilic myalgia syndrome.[3] Still sold in the US
Levamisole (Ergamisol) 1999 US Still 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 acetate 2003 US Cardiac arrhythmias and cardiac arrest.[2]
Lorcaserin (Belviq) 2020 US 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 intereaction.[3]
Methandrostenolone 1982 France, Germany, UK, US, others Off-label abuse.[3]
Methapyrilene 1979 Germany, UK, US 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 US Unspecific experimental toxicity.[3]
Mibefradil 1998 European Union, Malaysia, US, others Fatal arrhythmia, 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 US Voluntarily withdrawn from US market because of risk of Progressive multifocal leukoencephalopathy (PML). Returned to market July 2006.
Nefazodone 2004 Europe, 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.
Nialamide 1974 UK, US Hepatotoxicity, drug intereaction.[3]
Nikethamide 1988 multiple markets CNS Stimulation.[3]
Nitrefazole 1984 Germany Hepatic and hematologic toxicity.[3]
Nomifensine 1981–1986 France, Germany, Spain, UK, US, others Hemolytic Anemia, hepatotoxicity, serious hypersensitive reactions.[2][3]
Oxeladin 1976 Canada, UK, US (1976) Carcinogen.[38]
Oxyphenbutazone 1984–1985 UK, US, Germany, France, Canada Bone marrow suppression, Stevens–Johnson syndrome.[3][39][40]
Oxyphenisatin (Phenisatin) 1970s Australia, France, Germany, UK, US Hepatotoxicity.[3]
Ozogamicin 2010 US No improvement in clinical benefit; risk for death; veno-occlusive disease.[2]
Pemoline (Cylert) 1997 Canada, UK Withdrawn from US in 2005 due to hepatotoxicity.[41][3]
Pentobarbital 1980 Norway Risk of fatal overdose.[3]
Pentylenetetrazol 1982 US Withdrawn for inability to produce effective convulsive therapy, and for causing seizures.
Pergolide (Permax) 2007 US Risk for heart valve damage.[2]
Perhexiline 1985 UK, Spain Neurologic and hepatic toxicity.[3]
Phenacetin 1975 Canada An 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 Buformin 1977 France, Germany US Severe lactic acidosis[3]
Phenolphthalein 1997 US Possible carcinogen.[43]
Phenoxypropazine 1966 UK Hepatotoxicity, drug intereaction.[3]
Phenylbutazone 1985 Germany Off-label abuse, hematologic toxicity.[3]
Phenylpropanolamine (Propagest, Dexatrim) 2000 Canada, US Hemorrhagic stroke.[44][45]
Pifoxime (=Pixifenide) 1976 France Neuropsychiatric reaction.[3]
Pirprofen 1990 France, Germany, Spain Liver toxicity.[3][12]: 223 
Prenylamine 1988 Canada, France, Germany, UK, US, others Cardiac arrhythmia[46] and death.[3]
Proglumide 1989 Germany Respiratory reaction.[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 US, multiple markets Withdrawn in many countries because of risk of fatal bronchospasm.[2]
Remoxipride 1993 UK, others Aplastic anemia.[3]
rhesus rotavirus vaccine-tetravalent (RotaShield) 1999 US Withdrawn due to risk of intussusception.[47]
Rimonabant (Acomplia) 2008 Worldwide Risk of severe depression and suicide.[14]
Rofecoxib (Vioxx) 2004 Worldwide Withdrawn by Merck & Co. Risk of myocardial infarction and stroke.[2]
Rosiglitazone (Avandia) 2010 Europe Risk of heart attacks and death. This drug continues to be available in the US
Secobarbital France, Norway, others. Risk of overdose[3]
Sertindole 1998 European Union Arrhythmia 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 United States[59] Increased risk of heart attack and stroke.[2]
Sitaxentan 2010 Germany Hepatotoxicity.[14]
Sorivudine 1993 Japan Drug interaction and deaths.[60]
Sparfloxacin 2001 US QT prolongation and phototoxicity.[2]
Sulfacarbamide 1988 Germany Dermatologic, hematologic and hepatic reactions.[3]
Sulfamethoxydiazine 1988 Germany Unknown.[3]
Sulfamethoxypyridazine 1986 UK Dermatologic and hematologic reactions.[3]
Suloctidil 1985 Germany, France, Spain Hepatotoxicity.[3]
Suprofen 1986–1987 UK, Spain, US Kidney damage.[2][3]
Tegaserod (Zelnorm) 2007 US Risk for heart attack, stroke, and unstable angina.[2] Was available through a restricted access program until April 2008; returned to market in 2019.
Temafloxacin 1992 Germany, UK, US, others Low blood sugar; hemolytic anemia; kidney, liver dysfunction; allergic reactions[2][3]
Temafloxacin 1992 US Allergic reactions and cases of hemolytic anemia, leading to three patient deaths.[2]
Temazepam (Restoril, Euhypnos, Normison, Remestan, Tenox, Norkotral) 1999 Sweden, Norway 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 US, but under strict controls.
Terfenadine (Seldane, Triludan) 1997–1998 France, South Africa, Oman, others, US Prolonged QT interval; ventricular tachycardia[2][3]
Terodiline (Micturin) 1991 Germany, UK, Spain, others Prolonged QT interval, ventricular tachycardia and arrhythmia.[3]
Tetrazepam 2013 European Union Serious cutaneous reactions.[61]
Thalidomide 1961 Germany Withdrawn because of risk of teratogenicity;[62] returned to market for use in leprosy and multiple myeloma under FDA orphan drug rules
Thenalidine 1963 Canada, UK, US Neutropenia[3][63]
Thiobutabarbitone 1993 Germany Kidney injury.[3]
Thioridazine (Melleril) 2005 Germany, UK Withdrawn worldwide due to severe cardiac arrhythmias[64][65] Continues to be available in Russia.
Ticrynafen (Tienilic acid) 1980 Germany, France, UK, US 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, US Cataracts, alopecia, ichthyosis.[3]
Troglitazone (Rezulin) 2000 US, Germany Hepatotoxicity[2]
Trovafloxacin (Trovan) 1999–2001 European Union, US Withdrawn because of risk of liver failure[2][3]
Valdecoxib (Bextra) 2004 US Risk of heart attack and stroke.[2]
Vincamine 1987 Germany Hematologic toxicity.[3]
Xenazoic acid 1965 France Hepatotoxicity.[3]
Ximelagatran (Exanta) 2006 Germany Hepatotoxicity[14]
Zimelidine 1983 Worldwide Risk of Guillain–Barré syndrome, hypersensitivity reaction, hepatotoxicity[3][67][68] banned worldwide.[69]
Zomepirac 1983 UK, Germany, Spain, US Anaphylactic reactions and non-fatal allergic reactions, kidney failure[2][3]

See also

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References

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  63. ^ Drugbank. "Thenalidine". Archived from the original on 27 September 2013. Retrieved 24 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 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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