List of withdrawn drugs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Drugs or medicines may be withdrawn from commercial markets because of risks to patients, but also because of commercial reasons (e.g. lack of demand and relatively high production costs) or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 from postmarketing surveillance data collected from the wider community during routine use over longer periods of time.

Contents

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in Europe but had not yet been approved for marketing in the USA when adverse effects became clear and they were withdrawn from the market.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 USA or Europe.

Significant withdrawals

Drug name (INNs where available)WithdrawnCountryRemarks
Amfetamine - mixture of four salts (Adderall XR)2005CanadaWithdrawn after 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Alpidem (Ananxyl)1995WorldwideNot approved in the USA; withdrawn in France in 1994 [4] and the rest of the world in 1995 because of rare but serious hepatotoxicity [3] [5]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)2000USASerious gastrointestinal adverse events; ischaemic colitis; severe constipation; [2] reintroduced in 2002 with restricted indications and new controls [6]
Alphaxolone/Alphadolone

(Althesin)

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

(Cremophor EL) [3]

Amineptine (Survector)1999France, USA Hepatotoxicity, dermatological adverse effects, and abuse potential [7]
Aminophenazone (aminopyrine) 1999France, ThailandRisk of agranulocytosis and severe acne [3]
Amobarbital 1980NorwayRisk of barbiturate toxicity [3]
Amoproxan 1970FranceDermatological and ophthalmic toxicity [3]
Anagestone acetate 1969GermanyAnimal carcinogenicity [3]
Antrafenine 1984FranceUnspecific experimental toxicity [3]
Aprotinin (Trasylol)2008USAIncreased risk of death [2]
Ardeparin (Normiflo)2001USAWithdrawn at the request of the NDA originator, "not for reason of safety or efficacy" [8] [9]
Astemizole (Hismanal)1999USA, Malaysia, several nonspecified marketsFatal arrhythmia [2] [3]
Azaribine 1976USA Thromboembolism [3]
Bendazac 1993SpainHepatotoxicity [3]
Benoxaprofen (Oraflex, Opren)1982Germany, Spain, UK, USALiver and kidney failure; gastrointestinal bleeding; ulcers [2] [3]
Benzarone 1992GermanyHepatitis [3]
Benziodarone 1964France, UKJaundice [3]
Beta-ethoxy-acetanilanide 1986GermanyRenal toxicity, animal carcinogenicity [3]
Bezitramide 2004NetherlandsRisk of fatal overdose [10]
Bithionol 1967USADermatological toxicity [3]
Brotizolam 1989UKAnimal carcinogenicity [3]
Bromfenac 1998USASevere hepatitis and liver failure (requiring transplantation) [2]
Bucetin 1986GermanyKidney damage [3]
Buformin 1978GermanyMetabolic toxicity [3]
Bunamiodyl 1963Canada, UK, USANephropathy [11]
Butamben (Efocaine)(Butoforme)1964USADermatological toxicity; psychiatric reactions [3]
Canrenone 1986GermanyAnimal carcinogenicity [3]
Cerivastatin (Baycol, Lipobay)2001USARisk of rhabdomyolysis [2]
Chlormadinone (Chlormenadione)1970UK, USAAnimal carcinogenicity [3]
Chlormezanone (Trancopal)1996European Union, USA, South Africa, JapanHepatotoxicity and Stevens–Johnson Syndrome [3]
Chlorphentermine 1969GermanyCardiovascular toxicity [3]
Cianidanol 1985France, Germany, Spain, SwedenHaemolytic anaemia [3]
Cinepazide 1988SpainAgranulocytosis [12] [13]
Cisapride (Propulsid)2000USARisk of fatal cardiac arrhythmias [2]
Clioquinol 1973France, Germany, UK, USANeurotoxicity [3]
Clobutinol 2007GermanyVentricular arrhythmias, QT-interval prolongation [14]
Cloforex 1969GermanyCardiovascular toxicity [3]
Clomacron 1982UKHepatotoxicity [3]
Clometacin 1987FranceHepatotoxicity [3]
Co-proxamol (codeine + paracetamol; Distalgesic)2004UKRisk of overdose
Cyclobarbital 1980NorwayRisk of overdose [3]
Cyclofenil 1987FranceHepatotoxicity [3]
Dantron 1963Canada, UK, USA Mutagenic; [15] withdrawn from general use in the UK but permitted in terminal patients
Dexfenfluramine 1997European Union, UK, USA Cardiotoxic [3]
Propoxyphene (Darvocet/Darvon)2010WorldwideIncreased risk of heart attacks and stroke [16]
Diacetoxydiphenolisatin 1971AustraliaHepatotoxicity [3]
Diethylstilbestrol 1970sUSACarcinogen
Difemerine 1986GermanyMulti-organ toxicities [3]
Dihydrostreptomycin 1970USANeuropsychiatric reactions [3]
Dilevalol 1990UKHepatotoxicity [3]
Dimazole (Diamthazole)1972France, USANeuropsychiatric reactions [3]
Dimethylamylamine (DMAA)1983USAVoluntarily 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 1990UKUterine hypotonus, fetal distress [3]
Dipyrone (Metamizole)1975UK, USA, othersAgranulocytosis, anaphylactic reactions [3]
Dithiazanine iodide 1964France, USACardiovascular and metabolic reactions [3]
Dofetilide 2004GermanyDrug-drug interactions, prolonged QT [14]
Drotrecogin alfa (Xigris)2011WorldwideLack of efficacy as shown in the PROWESS-SHOCK study [19] [20] [21]
Ebrotidine 1998SpainHepatotoxicity [3]
Efalizumab (Raptiva)2009GermanyIncreased risk of progressive multifocal leukoencephalopathy [14]
Encainide 1991UK, USAVentricular arrhythmias [2] [3]
Ethyl carbamate 1963Canada, UK, USACarcinogen [22]
Etretinate 1989France Teratogen [2] [3]
Exifone 1989FranceHepatotoxicity [3]
Fen-phen (combination of fenfluramine + phentermine)1997Cardiotoxicity
Fenclofenac 1984UKCutaneous reactions; animal carcinogenicity [3]
Fenclozic acid 1970UK, USAHepatotoxicity [3]
Fenfluramine 1997European Union, UK, USA, India, South Africa, othersCardiac 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 1990New ZealandIncreased asthma mortality [3]
Feprazone 1984Germany, UKCutaneous reactions, multiorgan toxicity [3]
Fipexide 1991FranceHepatotoxicity [3]
Flosequinan (Manoplax)1993UK, USAIncreased mortality at higher doses; increased hospitalizations [2] [3]
Flunitrazepam 1991FranceAbuse [3]
Flupirtine 2018European UnionLiver toxicity [24]
Gatifloxacin 2006USAIncreased risk of dysglycaemia [2]
Gemtuzumab ozogamicin (Mylotarg)2010USANo improvement in clinical benefit; risk for death; [2] returned to market in 2017 [25]
Glafenine 1984France, GermanyAnaphylaxis [3]
Grepafloxacin (Raxar)1999Germany, UK, USA, 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 USA
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 1964USAMetabolic reactions [3]
Iproniazid 1964CanadaInteractions with food products containing tyrosine [28]
Isaxonine phosphate 1984FranceHepatotoxicity [3]
Isoxicam 1983France, Germany, Spain, othersStevens–Johnson syndrome [3]
Kava kava (Piper methysticum)2002GermanyHepatotoxicity [14]
Ketorolac 1993France, Germany, othersHaemorrhage, Kidney Failure [3]
L-tryptophan 1989Germany, UKEosinophilic myalgia syndrome; [3] still sold in the USA
Levamisole (Ergamisol)1999USAStill 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 of agranulocytosis [29] [30] [31]
Levomethadyl acetate 2003USACardiac arrhythmias and cardiac arrest [2]
Lorcaserin (Belviq)2020USAIncreased 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-drug interactions [3]
Methandrostenolone 1982France, Germany, UK, USA, othersOff-label abuse [3]
Methapyrilene 1979Germany, UK, USAAnimal 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 1965USAUnspecific experimental toxicity [3]
Mibefradil 1998European Union, Malaysia, USA, othersFatal arrhythmias, drug-drug interactions [2] [3]
Minaprine 1996FranceConvulsions [3]
Moxisylyte 1993FranceNecrotic hepatitis [3]
Muzolimine 1987France, Germany, European UnionPolyneuropathy [3]
Natalizumab (Tysabri)2005–2006USAVoluntarily withdrawn from the US market because of a risk of Progressive multifocal leukoencephalopathy (PML); returned to the market in July 2006
Nefazodone 2004Europe, 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 1974UK, USAHepatotoxicity, drug -drug interactions [3]
Nikethamide 1988Multiple marketsCNS stimulation [3]
Nitrefazole 1984GermanyHepatic and haematological toxicity [3]
Nomifensine 1981–1986France, Germany, Spain, UK, USA, othersHaemolytic anaemia, hepatotoxicity, serious hypersensitivity reactions [2] [3]
Oxeladin 1976Canada, UK, USA (1976)Carcinogen [38]
Oxyphenbutazone 1984–1985UK, USA, Germany, France, CanadaBone marrow suppression, Stevens–Johnson syndrome [3] [39] [40]
Oxyphenisatin (Phenisatin)1970sAustralia, France, Germany, UK, USAHepatotoxicity [3]
Ozogamicin 2010USANo improvement in clinical benefit; risk of death; veno-occlusive disease [2]
Pemoline (Cylert)1997Canada, UKWithdrawn in the USA in 2005 because of hepatotoxicity [41] [3]
Pentobarbital 1980NorwayRisk of fatal overdose [3]
Pentylenetetrazol 1982USAWithdrawn because of inability to produce effective convulsive therapy, and because it caused seizures
Pergolide (Permax)2007USARisk of heart valve damage [2]
Perhexiline 1985UK, SpainNeurological and hepatic toxicity [3]
Phenacetin 1975CanadaAn ingredient in "APC" tablets (aspirin + phenacetin + caffeine); withdrawn because of risks of cancer and kidney disease [42] in Germany, Denmark, UK, USA, and in others because of nephropathy [3]
Phenformin and Buformin 1977France, Germany, USASevere lactic acidosis [3]
Phenolphthalein 1997USAPossible carcinogen [43]
Phenoxypropazine 1966UKHepatotoxicity, drug-drug intereactions [3]
Phenylbutazone 1985GermanyOff-label abuse, haematological toxicity [3]
Phenylpropanolamine (Propagest, Dexatrim)2000Canada, USAHaemorrhagic stroke [44] [45]
Pifoxime (=Pixifenide)1976FranceNeuropsychiatric reactions [3]
Pirprofen 1990France, Germany, SpainLiver toxicity. [3] [12] : 223 
Prenylamine 1988Canada, France, Germany, UK, USA, othersCardiac arrhythmias [46] and death [3]
Proglumide 1989GermanyRespiratory reactions [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)2001USA, multiple marketsWithdrawn in many countries because of the risk of fatal bronchospasm [2]
Remoxipride 1993UK, othersAplastic anaemia [3]
Rhesus rotavirus vaccine-tetravalent (RotaShield)1999USAWithdrawn because of a risk of intussusception [47]
Rimonabant (Acomplia)2008WorldwideRisk of severe depression and suicide [14]
Rofecoxib (Vioxx)2004WorldwideWithdrawn by Merck & Co. because of the risks of myocardial infarction and stroke [2]
Rosiglitazone (Avandia)2010EuropeRisk of heart attacks and death; still available in the USA
Secobarbital 1990France, Norway, others[ which? ]Risk of overdose [3]
Sertindole 1998European 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] USA [59] Increased risk of heart attack and stroke [2]
Sitaxentan 2010GermanyHepatotoxicity [14]
Sorivudine 1993JapanDrug-drug interactions and deaths [60]
Sparfloxacin 2001USAQT interval prolongation and phototoxicity [2]
Sulfacarbamide 1988GermanyDermatological, hematological, and hepatic reactions [3]
Sulfamethoxydiazine 1988GermanyDermatological reactions
Sulfamethoxypyridazine 1986UKDermatological and haematological reactions [3]
Suloctidil 1985Germany, France, SpainHepatotoxicity [3]
Suprofen 1986–1987UK, Spain, USAKidney damage [2] [3]
Tegaserod (Zelnorm)2007USARisks 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 1992Germany, UK, USA, othersLow blood sugar; haemolytic anaemia; kidney, liver dysfunction; allergic reactions [2] [3]
Temafloxacin 1992USAllergic reactions and cases of haemolytic anaemia, leading to three deaths
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 USA, but under strict controls
Terfenadine (Seldane, Triludan)1997–1998France, South Africa, Oman, USA, othersProlonged QT interval; ventricular tachycardia [2] [3]
Terodiline (Micturin)1991Germany, UK, Spain, othersProlonged QT interval, ventricular tachycardia, and other arrhythmias [3]
Tetrazepam 2013European UnionSerious cutaneous reactions [61]
Thalidomide 1961GermanyWithdrawn because of risk of teratogenicity; [62] returned to the market for use in leprosy and multiple myeloma under FDA orphan drug rules
Thenalidine 1963Canada, UK, USANeutropenia [3] [63]
Thiobutabarbital 1993GermanyKidney damage [3]
Thioridazine (Melleril)2005Germany, UKWithdrawn worldwide because of severe cardiac arrhythmias; [64] [65] still available in Russia
Ticrynafen (Tienilic acid)1980Germany, France, UK, USA, 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, USACataracts, alopecia, ichthyosis [3]
Troglitazone (Rezulin)2000Germany, USA Hepatotoxicity [2]
Trovafloxacin (Trovan)1999–2001European Union, USAWithdrawn because of risk of liver failure [2] [3]
Valdecoxib (Bextra)2004USARisk of heart attack and stroke [2]
Vincamine 1987GermanyHaematological toxicity [3]
Xenazoic acid 1965FranceHepatotoxicity [3]
Ximelagatran (Exanta)2006GermanyHepatotoxicity [14]
Zimeldine 1983WorldwideRisk of Guillain–Barré syndrome, hypersensitivity reactions, hepatotoxicity; [3] [67] [68] banned worldwide. [69]
Zomepirac 1983UK, Germany, Spain, USA Anaphylactic reactions and non-fatal allergic reactions; kidney failure [2] [3]

See also

References

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  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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  47. ↑ "Withdrawal of Rotavirus Vaccine Recommendation". www.cdc.gov.
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  49. ↑ "Sibutramine (brand name Reductil) Information – Australia". Abbott Laboratories. 2010. Archived from the original on 2010-10-14. Retrieved 2010-10-08.
  50. ↑ Health Canada Endorsed Important Safety Information on MERIDIA (Sibutramine Hydrochloride Monohydrate) Archived 2013-01-11 at the Wayback Machine : Subject: Voluntary withdrawal of Meridia (sibutramine) capsules from the Canadian market.
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  54. ↑ "Banned Medicines" (Press release). Ministry of Health and Family Welfare. February 10, 2011. Archived from the original on July 23, 2012. Retrieved 2011-03-15.
  55. ↑ "Withdrawal of Sibutramine (Reductil) in New Zealand" (Press release). MedSafe in New Zealand. October 11, 2010. Archived from the original on October 14, 2012. Retrieved 2012-11-06.
  56. ↑ "FDA warns online sellers of banned slimming pills". January 12, 2014. Archived from the original on February 21, 2014. Retrieved February 20, 2014.
  57. ↑ "Thai FDA reveals voluntary withdrawal of sibutramine from the Thai market" (PDF) (Press release). Food and Drug Administration of Thailand. October 20, 2010. Archived from the original (PDF) on May 11, 2011. Retrieved 2010-12-22.
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