List of withdrawn drugs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Some drugs have been withdrawn from the market because of risks to the patients.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 US, when side effects became clear and their developers pulled them from the market. LSD was never approved for marketing in the US or Europe.

Significant withdrawals

Drug name Withdrawn Country Remarks
Adderall XR 2005 Canada Risk 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.
Alatrofloxacin 2006 Worldwide Liver toxicity; serious liver injury leading to liver transplant; death.[2]
Alclofenac 1979 UK Vasculitis, Rash.[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Alpidem (Ananxyl) 1995 Worldwide Not approved in the US, withdrawn in France in 1994[4] and the rest of the market in 1995 because of rare but serious hepatotoxicity.[3][5]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 on a restricted basis[citation needed]
Althesin (=Alphaxolone amineptine + Alphadolone) 1984 France, Germany, UK Anaphylaxis.[3]
Amineptine (Survector) 1999 France, US Hepatotoxicity, dermatological side effects, and abuse potential.[6] Reason:
Aminopyrine 1999 France, Thailand risk of agranulocytosis; severe acne.[3]
Amobarbital 1980 Norway Self poisoning.[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 Not for reasons of safety or efficacy.[7]
Astemizole (Hismanal) 1999 US, Malaysia, Multiple Nonspecified Markets Fatal arrhythmia[2][3]
Azaribine 1976 US Thromboembolism.[3]
Bendazac 1993) Spain Hepatotoxicity.[3]
Benoxaprofen 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 Fatal overdose.[8]
Bithionol 1967 US Dermatologic toxicity.[3]
Broazolam 1989 UK Animal carcinogenicity.[3]
Bromfenac 1998 US Severe hepatitis and liver failure (some requiring transplantation).[2]
Bucetin 1986 Germany Renal toxicity.[3]
Buformin 1978 Germany Metabolic toxicity.[3]
Bunamiodyl 1963 Canada, UK, US Nephropathy.[9]
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; Steven-Johnson Syndrome; Toxic Epidermal Necrolysis.[3]
Chlorphentermine 1969 Germany Cardiovascular Toxicity.[3]
Cianidanol 1985 France, Germany, Spain, Sweden Hemolytic Anemia.[3]
Cinepazide 1988 Spain Agranulocytosis.[10][11]
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.[12]
Cloforex 1969 Germany Cardiovascular toxicity.[3]
Clomacron 1982 UK Hepatotoxicity.[3]
Clometacin 1987 France Hepatotoxicity.[3]
Co-proxamol (Distalgesic) 2004 UK Overdose dangers.
Cyclobarbital 1980 Norway Self poisoning.[3]
Cyclofenil 1987 France Hepatotoxicity.[3]
Dantron 1963 Canada, UK, US Genotoxicity.[13]
Dexfenfluramine 1997 European Union, UK, US Cardiac valvular disease.[3]
Propoxyphene (Darvocet/Darvon) 2010 Worldwide Increased risk of heart attacks and stroke.[14]
Diacetoxydiphenolisatin 1971 Australia Hepatotoxicity.[3]
Diethylstilbestrol 1970s Risk of teratogenicity[citation needed]
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.[15]:12 Reintroduced as a dietary supplement in 2006;[15]:13 and in 2013 the FDA started work to ban it due to cardiovascular problems[16]
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.[12]
Drotrecogin alfa (Xigris) 2011 Worldwide Lack of efficacy as shown by PROWESS-SHOCK study[17][18][19]
Ebrotidine 1998 Spain Hepatotoxicity.[3]
Efalizumab (Raptiva) 2009 Germany Withdrawn because of increased risk of progressive multifocal leukoencephalopathy[12]
Encainide 1991 UK, US Ventricular arrhythmias.[2][3]
Ethyl carbamate 1963 Canada, UK, US, Carcinogenicity.[20]
Etretinate 1989 France Withdrawn US (1999). Risk for birth defects.[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 Jaundice, elevated hepatic enzymes.[3]
Fenfluramine 1997 European Union, UK, US, India, South Africa, others Cardiac valvular disease, pulmonary hypertension, cardiac fibrosis.[3][21]
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]
Gatifloxacin 2006 US Increased risk of dysglycemia.[2]
Gemtuzumab ozogamicin (Mylotarg) 2010 US No improvement in clinical benefit; risk for death.[2]
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]
Iodinated casein strophantin 1964 US Metabolic reaction.[3]
Iproniazid 1964 Canada Interactions with food products containing tyrosine.[22]
Isaxonine phosphate 1984 France Hepatotoxicity.[3]
Isoxicam 1983 France, Germany, Spain, others Stevens johnson syndrome.[3]
Kava Kava 2002 Germany Hepatotoxicity.[12]
Ketorolac 1993 France, Germany, others Hemorrhage, renal 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.[23] [24][25]
Levomethadyl acetate 2003 US Cardiac arrhythmias and cardiac arrest.[2]
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[26][27]
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 2007 US, Canada, others Branded version withdrawn by originator in several countries in 2007 for hepatotoxicity. Generic versions available.[28]
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) Carcinogenicity.[29]
Oxyphenbutazone 1984-1985 UK, US, Germany, France, Canada Bone marrow suppression, Steven Johnson Syndrome.[3][30]
Oxyphenisatin (Phenisatin) 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. Hepatotoxicity[31] Reason:hepatotoxicity.[3]
Pentobarbital 1980 Norway Self poisoning.[3]
Pentylenetetrazol 1982 Withdrawn for inability to produce effective convulsive therapy, and for causing seizures.
Pergolide (Permax) 2007 US Risk for heart valve damage.[2]
Perhexilene 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[32] Germany Denmark, UK, US, others Reason: nephropathy.[3]
Phenformin and Buformin 1977 France, Germany US Severe lactic acidosis[3]
Phenolphthalein 1997 US Carcinogenicity.[33]
Phenoxypropazine 1966 UK Hepatotoxicity, drug intereaction.[3]
Phenylbutazone 1985 Germany Off-label abuse, hematologic toxicity.[3]
Phenylpropanolamine(Propagest, Dexatrim) 2000 Canada, US Hemorrhagic stroke.[34][35]
Pifoxime (=Pixifenide) 1976 France Neuropsychiatric reaction.[3]
Pirprofen 1990 France, Germany, Spain Liver toxicity.[3][36]:223
Prenylamine 1988 Canada,France, Germany, UK, US, others Cardiac arrythmia[37] 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]
Rapacuronium (Raplon) 2001 US, multiple markets Withdrawn in many countries because of risk of fatal bronchospasm[2]
Remoxipride 1993 UK, others Aplastic anemia.[3]
Rimonabant (Acomplia) 2008 Worldwide Risk of severe depression and suicide[12]
Rofecoxib (Vioxx) 2004 US 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. Self poisoning.[3]
Sertindole 1998 European Union Arrhythmia and sudden cardiac death[3][38]
Sibutramine (Reductil/Meridia) 2010 Australia,[39] Canada,[40] China,[41] the European Union (EU),[42] Hong Kong,[43] India,[44] Mexico, New Zealand,[45] the Philippines,[46] Thailand,[47] the United Kingdom,[48] and the United States[49] Increased risk of heart attack and stroke.[2]
Sitaxentan 2010 Germany Hepatotoxicity.[12]
Sorivudine 1993 Japan Drug interaction and deaths.[50]
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]
Suloctidyl 1985 Germany, France, Spain Hepatotoxicity.[3]
Suprofen 1986-1987 UK, Spain, US Flank pain, decreased kidney function.[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.
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.[51]
Thalidomide 1961 Germany Withdrawn because of risk of teratogenicity;[52] returned to market for use in leprosy and multiple myeloma under FDA orphan drug rules
Thenalidine 1960 Canada, UK, US Neutropenia[3][53]
Thiobutabarbitone 1993 Germany Renal insufficiency.[3]
Thioridazine (Melleril) 2005 Germany, UK Withdrawn worldwide due to severe cardiac arrhythmias[54][55]
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][56]
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[12]
Zimelidine 1983 Worldwide Risk of Guillain-Barré syndrome, hypersensitivity reaction, hepatotoxicity[3][57][58] banned worldwide.[59]
Zomepirac 1983 UK, Germany, Spain, US Anaphylactic reactions and non-fatal allergic reactions, renal failure[2][3]

See also

References

  1. ↑ Health Canada press release
  2. ↑ 2.00 2.01 2.02 2.03 2.04 2.05 2.06 2.07 2.08 2.09 2.10 2.11 2.12 2.13 2.14 2.15 2.16 2.17 2.18 2.19 2.20 2.21 2.22 2.23 2.24 2.25 2.26 2.27 2.28 2.29 2.30 Lua error in package.lua at line 80: module 'strict' not found.
  3. ↑ 3.000 3.001 3.002 3.003 3.004 3.005 3.006 3.007 3.008 3.009 3.010 3.011 3.012 3.013 3.014 3.015 3.016 3.017 3.018 3.019 3.020 3.021 3.022 3.023 3.024 3.025 3.026 3.027 3.028 3.029 3.030 3.031 3.032 3.033 3.034 3.035 3.036 3.037 3.038 3.039 3.040 3.041 3.042 3.043 3.044 3.045 3.046 3.047 3.048 3.049 3.050 3.051 3.052 3.053 3.054 3.055 3.056 3.057 3.058 3.059 3.060 3.061 3.062 3.063 3.064 3.065 3.066 3.067 3.068 3.069 3.070 3.071 3.072 3.073 3.074 3.075 3.076 3.077 3.078 3.079 3.080 3.081 3.082 3.083 3.084 3.085 3.086 3.087 3.088 3.089 3.090 3.091 3.092 3.093 3.094 3.095 3.096 3.097 3.098 3.099 3.100 3.101 3.102 3.103 3.104 3.105 3.106 3.107 3.108 3.109 3.110 3.111 3.112 3.113 3.114 Lua error in package.lua at line 80: module 'strict' not found.
  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. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  7. ↑ FDA Response to Citizen Request re Ardeparin
  8. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  9. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  10. ↑ Cite error: Invalid <ref> tag; no text was provided for refs named WHO2005
  11. ↑ 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 United Nations – New York, 2005
  12. ↑ 12.0 12.1 12.2 12.3 12.4 12.5 12.6 Lua error in package.lua at line 80: module 'strict' not found.
  13. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  14. ↑ FDA announcement
  15. ↑ 15.0 15.1 Col John Lammie et al. Report of the Department Of Defense: 1,3 Dimethylamylamine (Dmaa) Safety Review Panel June 3, 2013
  16. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  17. ↑ Drotrecogin Alfa (Activated) in Adults with Septic Shock , N Engl J Med 2012; 366:2055-2064, May 31, 2012, DOI: 10.1056/NEJMoa1202290
  18. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  19. ↑ http://www.businessweek.com/news/2011-10-25/lilly-pulls-xigris-off-markets-after-sepsis-drug-fails-study.html
  20. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  21. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  22. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  23. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  24. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  25. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  26. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  27. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  28. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  29. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  30. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  31. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  32. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  33. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  34. ↑ FDA Advisory
  35. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  36. ↑ 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
  37. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  38. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  39. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  40. ↑ Health Canada Endorsed Important Safety Information on MERIDIA (Sibutramine Hydrochloride Monohydrate): Subject: Voluntary withdrawal of Meridia (sibutramine) capsules from the Canadian market.
  41. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  42. ↑ (German) Sibutramin-Vertrieb in der Europäischen Union ausgesetzt [1]. Abbott Laboratories in Germany. Press Release 2010-01-21. Retrieved 2010-01-27
  43. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  44. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  45. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  46. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  47. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  48. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  49. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  50. ↑ H. Gurdon: Japan bans shingles drug after deaths BMJ 1994;309:627
  51. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  52. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  53. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  54. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  55. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  56. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  57. ↑ Fagius J, et al. Guillain-Barré syndrome following zimeldine treatment J Neurol Neurosurg Psychiatry. 1985 Jan;48(1):65-9.
  58. ↑ Pubchem record says "withdrawn in 1983"
  59. ↑ Lua error in package.lua at line 80: module 'strict' not found.

External links

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