List of withdrawn drugs

Last updated

Drugs or medicines may be withdrawn from commercial markets because of risks to patients, but also because of commercial reasons (e.g. lack of demand and relatively high production costs).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.

Contents

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

Drug nameWithdrawnCountryRemarks
Amphetamine Mix (Adderall XR)2005CanadaWithdrawn over reports of increased risk of stroke, reinstated after increased risk not found. [1]
Alatrofloxacin 2006WorldwideSerious hepatotoxicity leading to liver transplant or death. [2]
Alclofenac 1979UK Vasculitis [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Alpidem (Ananxyl)1995WorldwideNot approved in the US, withdrawn in France in 1994 [4] and the rest of the market in 1995 because of rare but serious hepatotoxicity.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, UK Anaphylaxis, possibly due to carrier oil (Cremophor EL). [3]
Amineptine (Survector)1999France, US Hepatotoxicity, dermatological side effects, and abuse potential. [7]
Aminopyrine 1999France, ThailandRisk of agranulocytosis and severe acne. [3]
Amobarbital 1980NorwayRisk of barbiturate toxicity. [3]
Amoproxan 1970FranceDermatologic and ophthalmic toxicity. [3]
Anagestone acetate 1969GermanyAnimal carcinogenicity. [3]
Antrafenine 1984FranceUnspecific 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]
Azaribine 1976US Thromboembolism. [3]
Bendazac 1993SpainHepatotoxicity. [3]
Benoxaprofen (Oraflex, Opren)1982Germany, Spain, UK, USLiver and kidney failure; gastrointestinal bleeding; ulcers. [2] [3]
Benzarone 1992GermanyHepatitis. [3]
Benziodarone 1964France, UKJaundice. [3]
Beta-ethoxy-lacetanilanide 1986GermanyRenal toxicity, animal carcinogenicity. [3]
Bezitramide 2004NetherlandsRisk of fatal overdose [10]
Bithionol 1967USDermatologic toxicity. [3]
Brotizolam 1989UKAnimal carcinogenicity. [3]
Bromfenac 1998USSevere hepatitis and liver failure (requiring transplantation). [2]
Bucetin 1986GermanyKidney damage [3]
Buformin 1978GermanyMetabolic toxicity. [3]
Bunamiodyl 1963Canada, UK, USNephropathy. [11]
Butamben (Efocaine)(Butoforme)1964USDermatologic toxicity; psychiatric reactions. [3]
Canrenone 1986GermanyAnimal 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]
Chlorphentermine 1969GermanyCardiovascular Toxicity. [3]
Cianidanol 1985France, Germany, Spain, SwedenHemolytic Anemia. [3]
Cinepazide 1988SpainAgranulocytosis. [12] [13]
Cisapride (Propulsid)2000USRisk of fatal cardiac arrhythmias [2]
Clioquinol 1973France, Germany, UK, USNeurotoxicity. [3]
Clobutinol 2007GermanyVentricular arrhythmia, QT-prolongation. [14]
Cloforex 1969GermanyCardiovascular toxicity. [3]
Clomacron 1982UKHepatotoxicity. [3]
Clometacin 1987FranceHepatotoxicity. [3]
Co-proxamol (Distalgesic)2004UKRisk of overdose
Cyclobarbital 1980NorwayRisk of overdose [3]
Cyclofenil 1987FranceHepatotoxicity. [3]
Dantron 1963Canada, UK, US Mutagenic. [15] withdrawn from general use in UK but permitted in terminal patients
Dexfenfluramine 1997European Union, UK, US Cardiotoxic [3]
Propoxyphene (Darvocet/Darvon)2010WorldwideIncreased risk of heart attacks and stroke. [16]
Diacetoxydiphenolisatin 1971AustraliaHepatotoxicity. [3]
Diethylstilbestrol 1970sUSCarcinogen
Difemerine 1986GermanyMulti-Organ toxicities. [3]
Dihydrostreptomycin 1970USNeuropsychiatric reaction. [3]
Dilevalol 1990UKHepatotoxicity. [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]
Dinoprostone 1990UKUterine hypotonus, fetal distress. [3]
Dipyrone (Metamizole)1975UK, US, OthersAgranulocytosis, anaphylactic reactions. [3]
Dithiazanine iodide 1964France, USCardiovascular and metabolic reaction. [3]
Dofetilide 2004GermanyDrug interactions, prolonged QT. [14]
Drotrecogin alfa (Xigris)2011WorldwideLack of efficacy as shown by PROWESS-SHOCK study [19] [20] [21]
Ebrotidine 1998SpainHepatotoxicity. [3]
Efalizumab (Raptiva)2009GermanyWithdrawn because of increased risk of progressive multifocal leukoencephalopathy [14]
Encainide 1991UK, USVentricular arrhythmias. [2] [3]
Ethyl carbamate 1963Canada, UK, USCarcinogen. [22]
Etretinate 1989France Teratogen. [2] [3]
Exifone 1989FranceHepatotoxicity. [3]
Fen-phen (popular combination of fenfluramine and phentermine)1997Cardiotoxicity
Fenclofenac 1984UKCutaneous reactions; animal carcinogenicity. [3]
Fenclozic acid 1970UK, USHepatotoxicity. [3]
Fenfluramine 1997European 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.
Fenoterol 1990New ZealandAsthma mortality. [3]
Feprazone 1984Germany, UKCutaneous reaction, multiorgan toxicity. [3]
Fipexide 1991FranceHepatotoxicity. [3]
Flosequinan (Manoplax)1993UK, USIncreased mortality at higher doses; increased hospitalizations. [2] [3]
Flunitrazepam 1991FranceAbuse. [3]
Flupirtine 2018European UnionLiver toxicity. [24]
Gatifloxacin 2006USIncreased risk of dysglycemia. [2]
Gemtuzumab ozogamicin (Mylotarg)2010USNo improvement in clinical benefit; risk for death. [2] Returned to market in 2017. [25]
Glafenine 1984France, 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
Ibufenac 1968UKHepatotoxicity, jaundice. [3]
Indalpine 1985FranceAgranulocytosis. [3]
Indoprofen 1983Germany, Spain, UKAnimal carcinogenicity, gastrointestinal toxicity. [3]
Ingenol mebutate gel 2020Suspended in EuropeIncreased risk of skin cancers. [26] [27]
Iodinated casein strophantin 1964USMetabolic reaction. [3]
Iproniazid 1964CanadaInteractions with food products containing tyrosine. [28]
Isaxonine phosphate 1984FranceHepatotoxicity. [3]
Isoxicam 1983France, Germany, Spain, othersStevens–Johnson syndrome. [3]
Kava Kava 2002GermanyHepatotoxicity. [14]
Ketorolac 1993France, Germany, othersHemorrhage, Kidney Failure. [3]
L-tryptophan 1989Germany, 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 acetate 2003USCardiac 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.
Mebanazine 1975UKHepatotoxicity, drug intereaction. [3]
Methandrostenolone 1982France, Germany, UK, US, othersOff-label abuse. [3]
Methapyrilene 1979Germany, UK, USAnimal carcinogenicity. [3]
Methaqualone 1984South Africa (1971), India (1984), United Nations (1971–1988)Withdrawn because of risk of addiction and overdose [33] [34]
Metipranolol 1990UK, othersUveitis. [3]
Metofoline 1965USUnspecific experimental toxicity. [3]
Mibefradil 1998European Union, Malaysia, US, othersFatal arrhythmia, drug interactions. [2] [3]
Minaprine 1996FranceConvulsions. [3]
Moxisylyte 1993FranceNecrotic hepatitis. [3]
Muzolimine 1987France, 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.
Nefazodone 2004Europe, 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 1974UK, USHepatotoxicity, drug intereaction. [3]
Nikethamide 1988multiple marketsCNS Stimulation. [3]
Nitrefazole 1984GermanyHepatic and hematologic toxicity. [3]
Nomifensine 1981–1986France, Germany, Spain, UK, US, othersHemolytic Anemia, hepatotoxicity, serious hypersensitive reactions. [2] [3]
Oxeladin 1976Canada, UK, US (1976)Carcinogen. [38]
Oxyphenbutazone 1984–1985UK, US, Germany, France, CanadaBone marrow suppression, Stevens–Johnson syndrome. [3] [39] [40]
Oxyphenisatin (Phenisatin)1970sAustralia, France, Germany, UK, USHepatotoxicity. [3]
Ozogamicin 2010USNo improvement in clinical benefit; risk for death; veno-occlusive disease. [2]
Pemoline (Cylert)1997Canada, UKWithdrawn from US in 2005 due to hepatotoxicity. [41] [3]
Pentobarbital 1980NorwayRisk of fatal overdose. [3]
Pentylenetetrazol 1982USWithdrawn for inability to produce effective convulsive therapy, and for causing seizures.
Pergolide (Permax)2007USRisk for heart valve damage. [2]
Perhexiline 1985UK, SpainNeurologic and hepatic toxicity. [3]
Phenacetin 1975CanadaAn 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 1977France, Germany USSevere lactic acidosis [3]
Phenolphthalein 1997USPossible carcinogen. [43]
Phenoxypropazine 1966UKHepatotoxicity, drug intereaction. [3]
Phenylbutazone 1985GermanyOff-label abuse, hematologic toxicity. [3]
Phenylpropanolamine (Propagest, Dexatrim)2000Canada, USHemorrhagic stroke. [44] [45]
Pifoxime (=Pixifenide)1976FranceNeuropsychiatric reaction. [3]
Pirprofen 1990France, Germany, SpainLiver toxicity. [3] [12] : 223 
Prenylamine 1988Canada, France, Germany, UK, US, othersCardiac arrythmia [46] and death. [3]
Proglumide 1989GermanyRespiratory reaction. [3]
Pronethalol 1965UKAnimal carcinogenicity. [3]
Propanidid 1983UKAllergy. [3]
Proxibarbal 1998Spain, France, Italy, Portugal, TurkeyImmunoallergic, thrombocytopenia. [3]
Pyrovalerone 1979FranceAbuse. [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]
Remoxipride 1993UK, 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
Secobarbital France, Norway, others.Risk of overdose [3]
Sertindole 1998European 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]
Sitaxentan 2010GermanyHepatotoxicity. [14]
Sorivudine 1993JapanDrug interaction and deaths. [60]
Sparfloxacin 2001USQT prolongation and phototoxicity. [2]
Sulfacarbamide 1988GermanyDermatologic, hematologic and hepatic reactions. [3]
Sulfamethoxydiazine 1988GermanyUnknown. [3]
Sulfamethoxypyridazine 1986UKDermatologic and hematologic reactions. [3]
Suloctidil 1985Germany, France, SpainHepatotoxicity. [3]
Suprofen 1986–1987UK, 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.
Temafloxacin 1992Germany, UK, US, othersLow blood sugar; hemolytic anemia; kidney, liver dysfunction; allergic reactions [2] [3]
Temafloxacin 1992USAllergic reactions and cases of hemolytic anemia, leading to three patient deaths.
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]
Tetrazepam 2013European UnionSerious cutaneous reactions. [61]
Thalidomide 1961GermanyWithdrawn because of risk of teratogenicity; [62] returned to market for use in leprosy and multiple myeloma under FDA orphan drug rules
Thenalidine 1963Canada, UK, USNeutropenia [3] [63]
Thiobutabarbitone 1993GermanyKidney 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]
Triacetyldiphenolisatin 1971AustraliaHepatotoxicity. [3]
Triazolam 1991France, Netherlands, Finland, Argentina, UK othersPsychiatric adverse drug reactions, amnesia. [3] [66]
Triparanol 1962France, USCataracts, alopecia, ichthyosis. [3]
Troglitazone (Rezulin)2000US, Germany Hepatotoxicity [2]
Trovafloxacin (Trovan)1999–2001European Union, USWithdrawn because of risk of liver failure [2] [3]
Valdecoxib (Bextra)2004USRisk of heart attack and stroke. [2]
Vincamine 1987GermanyHematologic toxicity. [3]
Xenazoic acid 1965FranceHepatotoxicity. [3]
Ximelagatran (Exanta)2006GermanyHepatotoxicity [14]
Zimelidine 1983WorldwideRisk of Guillain–Barré syndrome, hypersensitivity reaction, hepatotoxicity [3] [67] [68] banned worldwide. [69]
Zomepirac 1983UK, Germany, Spain, US Anaphylactic reactions and non-fatal allergic reactions, kidney failure [2] [3]

Withdrawn clinical trial drugs

See also

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References

  1. ↑ Branch, Government of Canada, Health Canada, Public Affairs, Consultation and Communications. "Health Canada – Home Page". Archived from the original on 28 June 2005. Retrieved 28 November 2016.{{cite web}}: CS1 maint: multiple names: authors list (link)
  2. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Qureshi, ZP; Seoane-Vazquez, E; Rodriguez-Monguio, R; Stevenson, KB; Szeinbach, SL (July 2011). "Market withdrawal of new molecular entities approved in the United States from 1980 to 2009". Pharmacoepidemiology and Drug Safety. 20 (7): 772–7. doi:10.1002/pds.2155. PMID   21574210. S2CID   23821961.
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  5. ↑ Berson, A; et al. (2001). "Toxicity of alpidem, a peripheral benzodiazepine receptor ligand, but not zolpidem, in rat hepatocytes: role of mitochondrial permeability transition and metabolic activation" (PDF). J Pharmacol Exp Ther. 299 (2): 793–800. PMID   11602696.
  6. ↑ Grady, Denise (2002-06-08). "U.S. Lets Drug Tied to Deaths Back on Market". The New York Times. ISSN   0362-4331 . Retrieved 2021-07-20.
  7. ↑ DrugBank. "Amineptine". Archived from the original on 27 September 2013. Retrieved 24 September 2013.
  8. ↑ "Determination That Ardeparin Sodium Injection Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness". Federal Register. 2002-05-23. Retrieved 2021-07-20.
  9. ↑ "FDA Response to Citizen Request re Ardeparin". fda.gov. Archived from the original on 18 January 2017. Retrieved 28 April 2018.
  10. ↑ DrugBank. "Bezitramide". Archived from the original on 27 September 2013. Retrieved 24 September 2013.
  11. ↑ DrugBank. "Bunamiodyl". Archived from the original on 27 September 2013. Retrieved 24 September 2013.
  12. 1 2 WHO. Consolidated List of Products – Whose Consumption and/or Sale Have Been Banned, Withdrawn, Severely Restricted or Not Approved by Governments, Twelfth Issue – Pharmaceuticals Archived 2014-11-09 at Wikiwix. United Nations – New York, 2005
  13. ↑ Department of Economic and Social Affairs of the United Nations Secretariat Consolidated List of Products Whose Consumption and/or Sale Have Been Banned, Withdrawn, Severely Restricted or not Approved by Governments Twelfth Issue: Pharmaceuticals Archived 2012-10-23 at the Wayback Machine United Nations – New York, 2005
  14. 1 2 3 4 5 6 7 Schubert-Zsilavecz, Manfred (2011). "Arzneimittelrücknahmen Rückrufe im Rückblick". Pharmazeutische Zeitung (German). Archived from the original on 27 September 2013. Retrieved 25 September 2013.
  15. ↑ DrugBank. "Dantron". Archived from the original on 27 September 2013. Retrieved 24 September 2013.
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