List of withdrawn drugs

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Some drugs have been withdrawn from the market because of risks to the patients. Usually this has been prompted by unexpected adverse effects that were not detected during Phase III clinical trials and were only apparent from postmarketing surveillance data from the wider patient community.

This list is not limited to drugs that were ever approved by the FDA. Some of them (Lumiracoxib, Rimonabant, Tolrestat, Ximelagatran and Zimelidine, for example) were approved to be marketed in Europe but had not yet been approved for marketing in the U.S., when side effects became clear and their developers pulled them from the market. LSD was never approved for marketing in the U.S or Europe.

Significant withdrawals[edit]

Drug nameWithdrawnCountryRemarks
Adderall XR2005CanadaRisk of stroke[1] The ban was later lifted because the death rate among those taking Adderall XR was determined to be no greater than those not taking Adderall.
Alatrofloxacin2006WorldwideLiver toxicity; serious liver injury leading to liver transplant; death.[2]
Alclofenac1979U.K.Vasculitis, Rash.[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Alpidem (Ananxyl)1995WorldwideNot approved in the US, withdrawn in France in 1994[4] and the rest of the market in 1995 because of rare but serious hepatotoxicity.[3][5]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 on a restricted basis[citation needed]
Althesin (=Alphaxolone amineptine + Alphadolone)1984France, Germany, U.K.Anaphylaxis.[3]
Amineptine (Survector)1999France, USHepatotoxicity, dermatological side effects, and abuse potential.[6] Reason:
Aminopyrine1999France, Thailandrisk of agranulocytosis; severe acne.[3]
Amobarbital1980NorwaySelf poisoning.[3]
Amoproxan1970FranceDermatologic and ophthalmic toxicity.[3]
Anagestone acetate1969GermanyAnimal carcinogenicity.[3]
Antrafenine1984FranceUnspecific experimental toxicity.[3]
Aprotinin (Trasylol)2008USIncreased risk of death.[2]
Ardeparin (Normiflo)2001USNot for reasons of safety or efficacy.[7]
Astemizole (Hismanal)1999U.S, Malaysia, Multiple Nonspecified MarketsFatal arrhythmia[2][3]
Azaribine1976USThromboembolism.[3]
Bendazac1993)SpainHepatotoxicity.[3]
Benoxaprofen1982Germany,Spain, U.K, U.SLiver and kidney failure; gastrointestinal bleeding; ulcers.[2][3]
Benzarone1992GermanyHepatitis.[3]
Benziodarone1964France, U.KJaundice.[3]
Beta-ethoxy-lacetanilanide1986GermanyRenal toxicity, animal carcinogenicity.[3]
Bezitramide2004NetherlandsFatal overdose.[8]
Bithionol1967USDermatologic toxicity.[3]
Broazolam1989UKAnimal carcinogenicity.[3]
Bromfenac1998USSevere hepatitis and liver failure (some requiring transplantation).[2]
Bucetin1986GermanyRenal toxicity.[3]
Buformin1978GermanyMetabolic toxicity.[3]
Bunamiodyl1963)Canada, U.K, U.S,Nephropathy.[9]
Butamben (Efocaine)(Butoforme)1964USDermatologic toxicity; psychiatric Reactions.[3]
Canrenone1986GermanyAnimal Carcinogenicity.[3]
Cerivastatin (Baycol, Lipobay)2001USRisk of rhabdomyolysis[2]
Chlormadinone (Chlormenadione)1970U.K, U.SAnimal Carcinogenicity.[3]
Chlormezanone (Trancopal)1996European Union, U.S, South Africa, JapanHepatotoxicity; Steven-Johnson Syndrome; Toxic Epidermal Necrolysis.[3]
Chlorphentermine1969GermanyCardiovascular Toxicity.[3]
Cianidanol1985France, Germany, Spain, SwedenHemolytic Anemia.[3]
Cinepazide1987SpainAgranulocytosis.[3]
Cisapride (Propulsid)2000USRisk of fatal cardiac arrhythmias[2]
Clioquinol1973France, Germany, U.K, U.S.Neurotoxicity.[3]
Clobutinol2007GermanyVentricular arrhythmia, QT-prolongation.[10]
Cloforex1969GermanyCardiovascular toxicity.[3]
Clomacron1982UKHepatotoxicity.[3]
Clometacin1987FranceHepatotoxicity.[3]
Co-proxamol (Distalgesic)2004UKOverdose dangers.
Cyclobarbital1980NorwaySelf poisoning.[3]
Cyclofenil1987FranceHepatotoxicity.[3]
Dantron1963Canada, U.K, U.S,Genotoxicity.[11]
Dexfenfluramine1997European Union, U.K, U.SCardiac valvular disease.[3]
Propoxyphene (Darvocet/Darvon)2010WorldwideIncreased risk of heart attacks and stroke.[12]
Diacetoxydiphenolisatin1971AustraliaHepatotoxicity.[3]
Diethylstilbestrol1970sRisk of teratogenicity[citation needed]
Difemerine1986GermanyMulti-Organ toxicities.[3]
Dihydrostreptomycin1970USNeuropsychiatric reaction.[3]
Dilevalol1990UKHepatotoxicity.[3]
Dimazol (Diamthazole)1972France, U.S.Neuropsychiatric reaction.[3]
Dimethylamylamine (DMAA)1983U.S.Voluntarily withdrawn from market by Lily.[13]:12 Reintroduced as a dietary supplement in 2006;[13]:13 and in 2013 the FDA started work to ban it due to cardiovascular problems[14]
Dinoprostone1990UKUterine hypotonus, fetal distress.[3]
Dipyrone(Metamizole)1975U.K, U.S, OthersAgranulocytosis, anaphylactic reactions.[3]
Dithiazanine iodide1964France, U.S.Cardiovascular and metabolic reaction.[3]
Dofetilide2004GermanyDrug intereactions, prolonged QT.[10]
Drotrecogin alfa (Xigris)2011WorldwideLack of efficacy as shown by PROWESS-SHOCK study[citation needed]
Ebrotidine1998SpainHepatotoxicity.[3]
Efalizumab (Raptiva)2009GermanyWithdrawn because of increased risk of progressive multifocal leukoencephalopathy[10]
Encainide1991U.K, U.S.Ventricular arrhythmias.[2][3]
Ethyl carbamate1963Canada, U.K, U.S,Carcinogenicity.[15]
Etretinate1989FranceWithdrawn U.S. (1999). Risk for birth defects.[2][3]
Exifone1989FranceHepatotoxicity.[3]
Fen-phen (popular combination of fenfluramine and phentermine)1997Cardiotoxicity
Fenclofenac1984UKCutaneous reactions; animal carcinogenicity.[3]
Fenclozic acid1970U.K, U.S.Jaundice, elevated hepatic enzymes.[3]
Fenfluramine1997European Union, U.K, U.S, India, South Africa, othersCardiac valvular disease, pulmonary hypertension, cardiac fibrosis.[3][16]
Fenoterol1990New ZealandAsthma mortality.[3]
Feprazone1984Germany, U.KCutaneous reaction, multiorgan toxicity.[3]
Fipexide1991FranceHepatotoxicity.[3]
Flosequinan (Manoplax)1993U.K, U.S, othersIncreased mortality at higher doses; increased hospitalizations.[2][3]
Flunitrazepam1991FranceAbuse.[3]
Gatifloxacin2006USIncreased risk of dysglycemia.[2]
Gemtuzumab ozogamicin (Mylotarg)2010USNo improvement in clinical benefit; risk for death.[2]
Glafenine1984France, GermanyAnaphylaxis.[3]
Grepafloxacin (Raxar)1999Withdrawn Germany, U.K, U.S othersCardiac repolarization; QT interval prolongation.[2]
Hydromorphone (Palladone)]2005High risk of accidental overdose when administered with alcohol
Ibufenac1968U.K.Hepatotoxicity, jaundice.[3]
Indalpine1985FranceAgranulocytosis.[3]
Indoprofen1983Germany, Spain, U.K.Animal carcinogenicity, gastrointestinal toxicity.[3]
Iodinated casein strophantin1964USMetabolic reaction.[3]
Iproniazid1964CanadaInteractions with food products containing tyrosine.[17]
Isaxonine phosphate1984FranceHepatotoxicity.[3]
Isoxicam1983France, Germany, Spain, othersStevens johnson syndrome.[3]
Kava Kava2002GermanyHepatotoxicity.[10]
Ketorolac1993France, Germany, othersHemorrhage, renal Failure.[3]
L-tryptophan1989Germany, U.K.Eosinophilic myalgia syndrome.[3]
Levamisole (Ergamisol)1999Still 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[citation needed].
Levomethadyl acetate2003USCardiac arrhythmias and cardiac arrest.[2]
Lumiracoxib (Prexige)2007–2008WorldwideLiver damage
Lysergic acid diethylamide (LSD)1950s–1960sMarketed as a psychiatric drug; withdrawn after it became widely used recreationally
Mebanazine1975UKHepatotoxicity, drug intereaction.[3]
Methandrosteronolone1982France, Germany, U.K, U.S, othersOff-label abuse.[3]
Methapyrilene1979Germany, U.K, U.SAnimal carcinogenicity.[3]
Methaqualone1984South Africa (1971), India (1984), United Nations (1971-1988)Withdrawn because of risk of addiction and overdose[18][19]
Metipranolol1990U.K, othersUveitis.[3]
Metofoline1965USUnspecific experimental toxicity.[3]
Mibefradil1998European Union, Malaysia, U.S, othersFatal arrhythmia, drug interactions.[2][3]
Mibefradil (Posicor)1998Withdrawn because of dangerous interactions with other drugs
Minaprine1996FranceConvulsions.[3]
Moxisylyte1993FranceNecrotic hepatitis.[3]
Muzolimine1987France, Germany,European UnionPolyneuropathy.[3]
Natalizumab (Tysabri)2005–2006USVoluntarily withdrawn from U.S. market because of risk of Progressive multifocal leukoencephalopathy (PML). Returned to market July, 2006.
Nefazodone2007US, Canada, othersBranded version withdrawn by originator in several countries in 2007 for hepatotoxicity. Generic versions available.[20]
Nialamide1974U.K, U,S.Hepatotoxicity, drug intereaction.[3]
Nikethamide1988)multiple marketsCNS Stimulation.[3]
Nitrefazole1984)GermanyHepatic and hematologic toxicity.[3]
Nomifensine1981-1986France, Germany, Spain, U.K, U.S, othersHemolytic Anemia, hepatotoxicity, serious hypersensitive reactions.[2][3]
Oxeladin1976Canada, U.K, U.S. (1976)Carcinogenicity.[21]
Oxyphenbutazone1984-1985U.K, U.S, Germany, France, CanadaBone marrow suppression, Steven Johnson Syndrome.[3][22]
Oxyphenisatin (Phenisatin)Australia, France, Germany, U.K, U.S.Hepatotoxicity.[3]
Ozogamicin2010USNo improvement in clinical benefit; risk for death; veno-occlusive disease.[2]
Pemoline (Cylert)1997Canada, U.KWithdrawn from U.S in 2005. Hepatotoxicity[23] Reason:hepatotoxicity.[3]
Pentobarbital1980NorwaySelf poisoning.[3]
Pentylenetetrazol1982Withdrawn for inability to produce effective convulsive therapy, and for causing seizures.
Pergolide (Permax)2007USRisk for heart valve damage.[2]
Perhexilene1985U.K, SpainNeurologic and hepatic toxicity.[3]
Phenacetin1975CanadaAn ingredient in "A.P.C." tablet; withdrawn because of risk of cancer and kidney disease[24] Germany Denmark, U.K, U.S, others Reason: nephropathy.[3]
Phenformin and Buformin1977France, Germany U.S.Severe lactic acidosis[3]
Phenolphthalein1997USCarcinogenicity.[25]
Phenoxypropazine1966UKHepatotoxicity, drug intereaction.[3]
Phenylbutazone1985GermanyOff-label abuse, hematologic toxicity.[3]
Phenylpropanolamine(Propagest, Dexatrim)2000Canada, U.S.Hemorrhagic stroke.[26][27]
Pifoxime (=Pixifenide)1976FranceNeuropsychiatric reaction.[3]
Pirprofen1990France, Germany, SpainLiver toxicity.[3][28]:223
Prenylamine1988Canada,France, Germany, U.K, U.S, othersCardiac arrythmia[29] and death.[3]
Proglumide1989GermanyRespiratory reaction.[3]
Pronethalol1965UKAnimal carcinogenicity.[3]
Propanidid1983UKAllergy.[3]
Proxibarbal1998Spain, France, Italy, Portugal, TurkeyImmunoallergic, thrombocytopenia.[3]
Pyrovalerone1979FranceAbuse.[3]
Rapacuronium (Raplon)2001US. multiple marketsWithdrawn in many countries because of risk of fatal bronchospasm[2]
Remoxipride1993U.K, othersAplastic anemia.[3]
Rimonabant (Acomplia)2008WorldwideRisk of severe depression and suicide[10]
Rofecoxib (Vioxx)2004USRisk of myocardial infarction and stroke[2]
Rosiglitazone (Avandia)2010EuropeRisk of heart attacks and death. This drug continues to be available in the U.S.
SecobarbitalFrance, Norway, others.Self poisoning.[3]
Sertindole1998European UnionArrhythmia and sudden cardiac death[3][30]
Sibutramine (Reductil/Meridia)2010Australia,[31] Canada,[32] China,[33] the European Union (EU),[34] Hong Kong,[35] India,[36] Mexico, New Zealand,[37] the Philippines,[38] Thailand,[39] the United Kingdom,[40] and the United States[41]Increased risk of heart attack and stroke.[2]
Sitaxentan2010GermanyHepatotoxicity.[10]
Sorivudine1993JapanDrug interaction and deaths.[citation needed]
Sparfloxacin2001U.S.QT prolongation and phototoxicity.[2]
Sulfacarbamide1988GermanyDermatologic, hematologic and hepatic reactions .[3]
Sulfamethoxydiazine1988GermanyUnknown.[3]
Sulfamethoxypyridazine1986UKDermatologic and hematologic reactions.[3]
Suloctidyl1985Germany, France, SpainHepatotoxicity.[3]
Suprofen1986-1987U.K, Spain, USFlank pain, decreased kidney function.[2][3]
Tegaserod (Zelnorm)2007USRisk for heart attack, stroke, and unstable angina.[2] Was available through a restricted access program until April 2008.
Temafloxacin1992Germany, U.K, U.S, othersLow blood sugar; hemolytic anemia; kidney, liver dysfunction; allergic reactions[2][3]
Temafloxacin1992USAllergic reactions and cases of hemolytic anemia, leading to three patient deaths.[2]
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 U.S., but under strict controls.
Terfenadine (Seldane, Triludan)1997-1998France, South Africa, Oman, others, USProlonged QT interval; ventricular tachycardia[2][3]
Terodiline (Micturin)1991Germany, U.K, Spain, othersProlonged QT interval, ventricular tachycardia and arrhythmia.[3]
Tetrazepam2013European UnionSerious cutaneous reactions.[42]
Thalidomide1961GermanyWithdrawn because of risk of teratogenicity;[43] returned to market for use in leprosy and multiple myeloma under FDA orphan drug rules
Thenalidine1960Canada, U.K, U.S.Neutropenia[3][44]
Thiobutabarbitone1993GermanyRenal insufficiency.[3]
Thioridazine (Melleril)2005Germany, UKWithdrawn from U.K. market because of cardiotoxicity[10]
Ticrynafen(Tienilic acid)1980Germany, France, U.K, U.S 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, U.K. othersPsychiatric adverse drug reactions, amnesia.[3][45]
Triparanol1962France, U.S.Cataracts, alopecia, ichthyosis.[3]
Troglitazone (Rezulin)2000US. GermanyHepatotoxicity[2]
Trovafloxacin (Trovan)1999-2001European Union, USWithdrawn because of risk of liver failure[2][3]
Valdecoxib (Bextra)2004USRisk of heart attack and stroke.[2]
Vincamine1987GermanyHematologic toxicity.[3]
Xenazoic acid1965FranceHepatotoxicity.[3]
Ximelagatran (Exanta)2006GermanyHepatotoxicity[10]
Zimelidine1983WorldwideRisk of Guillain-Barré syndrome, hypersensitivity reaction, hepatotoxicity[3][46][47] banned worldwide.[48]
Zomepirac1983U.K, Germany, Spain, U.S.Anaphylactic reactions and non-fatal allergic reactions, renal failure[2][3]

See also[edit]

References[edit]

  1. ^ Health Canada press release
  2. ^ a b c d e f g h i j k l m n o p q r s t u v w x y z aa ab ac ad ae 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. 
  3. ^ a b c d e f g h i j k l m n o p q r s t u v w x y z aa ab ac ad ae af ag ah ai aj ak al am an ao ap aq ar as at au av aw ax ay az ba bb bc bd be bf bg bh bi bj bk bl bm bn bo bp bq br bs bt bu bv bw bx by bz ca cb cc cd ce cf cg ch ci cj ck cl cm cn co cp cq cr cs ct cu cv cw cx cy cz da db dc dd de df dg dh di dj dk dl Fung, M.; Thornton, A.; Mybeck, K.; Wu, J. H.-h.; Hornbuckle, K.; Muniz, E. (1 January 2001). "Evaluation of the Characteristics of Safety Withdrawal of Prescription Drugs from Worldwide Pharmaceutical Markets-1960 to 1999". Therapeutic Innovation & Regulatory Science 35 (1): 293–317. doi:10.1177/009286150103500134. 
  4. ^ WHO Drug Information Vol. 8, No. 2, 1994, page 64
  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. J Pharmacol Exp Ther. 299(2):793-800.
  6. ^ DrugBank. "Amineptine". Retrieved 24 September 2013. 
  7. ^ FDA Response to Citizen Request re Ardeparin
  8. ^ DrugBank. "Bezitramide". Retrieved 24 September 2013. 
  9. ^ DrugBank. "Bunamiodyl". Retrieved 24 September 2013. 
  10. ^ a b c d e f g h Schubert-Zsilavecz, Manfred (2011). "Arzneimittelrücknahmen Rückrufe im Rückblick". Pharmazeutische Zeitung (German). Retrieved 25 September 2013. 
  11. ^ DrugBank. "Dantron". Retrieved 24 September 2013. 
  12. ^ FDA announcement
  13. ^ a b Col John Lammie et al. Report of the Department Of Defense: 1,3 Dimethylamylamine (Dmaa) Safety Review Panel June 3, 2013
  14. ^ FDA. "Stimulant Potentially Dangerous to Health, FDA Warns". Retrieved 26 January 2014. 
  15. ^ DrugBank. "Ethyl carbamate". Retrieved 24 September 2013. 
  16. ^ DrugBank. "Fenfluramine". Retrieved 24 September 2013. 
  17. ^ DrugBank. "Iproniazid". Retrieved 24 September 2013. 
  18. ^ Central Drugs Standard Control Organization. "Drugs Banned In India". Ministry of Health and Family Welfare, Government of India. Retrieved 24 September 2013. 
  19. ^ "Drug Effects - Methaqualone". South African Police Service. Retrieved 24 September 2013. 
  20. ^ Cosgrove-Mather, Bootie (December 5, 2007). "Anti-Depressant Taken Off Market". CBS NEWS. Retrieved 29 September 2013. 
  21. ^ DrugBank. "Oxeladin". Retrieved 24 September 2013. 
  22. ^ DrugBank. "Oxyphenbutazone". Retrieved 24 September 2013. 
  23. ^ DrugBank. "Pemoline". Retrieved 24 September 2013. 
  24. ^ DrugBank. "Phenacetin". Retrieved 24 September 2013. 
  25. ^ Wysowski, Diane K. (2005). "Adverse Drug Event Surveillance and Drug Withdrawals in the United States, 1969-2002<subtitle>The Importance of Reporting Suspected Reactions</subtitle>". Archives of Internal Medicine 165 (12): 1363–9. doi:10.1001/archinte.165.12.1363. PMID 15983284.  |first2= missing |last2= in Authors list (help)
  26. ^ FDA Advisory
  27. ^ DrugBank. "Phenylpropanolamine". Retrieved 24 September 2013. 
  28. ^ WHO. Consolidated List of Products - Whose Consumption and/or Sale Have Been Banned, Withdrawn, Severely Restricted or Not Approved by Governments, Twelfth Issue - Pharmaceuticals. United Nations - New York, 2005
  29. ^ DrugBank. "Prenylamine". Retrieved 24 September 2013. 
  30. ^ DrugBank. "Sertindole". Retrieved 24 September 2013. 
  31. ^ "Sibutramine (brand name Reductil) Information - Australia". Abbott Laboratories. 2010. Retrieved 2010-10-08. 
  32. ^ Health Canada Endorsed Important Safety Information on MERIDIA (Sibutramine Hydrochloride Monohydrate): Subject: Voluntary withdrawal of Meridia (sibutramine) capsules from the Canadian market.
  33. ^ "Notification of Termination of Production, Sale, and Usage of Sibutramine Preparations and Their Active Pharmaceutical Ingredient". sda.gov in People's Republic of China. October 30, 2010. Retrieved 2011-05-21. 
  34. ^ (German) Sibutramin-Vertrieb in der Europäischen Union ausgesetzt [1]. Abbott Laboratories in Germany. Press Release 2010-01-21. Retrieved 2010-01-27
  35. ^ "De-registration of pharmaceutical products containing sibutramine" (Press release). info.gov in Hong Kong. November 2, 2010. Retrieved 2010-11-08. 
  36. ^ "Banned Medicines" (Press release). Ministry of Health and Family Welfare. February 10, 2011. Retrieved 2011-03-15. 
  37. ^ "Withdrawal of Sibutramine (Reductil) in New Zealand" (Press release). MedSafe in New Zealand. October 11, 2010. Retrieved 2012-11-06. 
  38. ^ "FDA warns online sellers of banned slimming pills". January 12, 2014. Retrieved February 20, 2014. 
  39. ^ "Thai FDA reveals voluntary withdrawal of sibutramine from the Thai market" (Press release). Food and Drug Administration of Thailand. October 20, 2010. Retrieved 2010-12-22. 
  40. ^ "Top obesity drug sibutramine being suspended". BBC News. 2010-01-22. Retrieved 2010-01-22. 
  41. ^ Rockoff, Jonathan D.; Dooren, Jennifer Corbett (October 8, 2010). "Abbott Pulls Diet Drug Meridia Off US Shelves". The Wall Street Journal. Retrieved 8 October 2010. 
  42. ^ Paar, W.D; Müller-Jakic. "Ruhen der Zulassung Tetrazepam haltiger Arzneimittel in der EU (German)". Sanofi-Aventis Deutschland GmbH. Retrieved 25 September 2013. 
  43. ^ Luippold, Gerd (2006). "Renaissance des Contergan-Wirkstoffs". Pharmazeutische Zeitung (German). Retrieved 25 September 2013. 
  44. ^ Drugbank. "Thenalidine". Retrieved 24 September 2013. 
  45. ^ DrugBank. "Triazolam". Retrieved 24 September 2013. 
  46. ^ Fagius J, et al. Guillain-Barré syndrome following zimeldine treatment J Neurol Neurosurg Psychiatry. 1985 Jan;48(1):65-9.
  47. ^ Pubchem record says "withdrawn in 1983"
  48. ^ DrugBank. "Zimelidine". Retrieved 24 September 2013. 

External links[edit]