Usuari:Enrospv/Annex:Medicaments retirats

De la Viquipèdia, l'enciclopèdia lliure

Els fàrmacs o medicines poden ser retirats dels mercats arran dels seus riscos en pacients, però per raons comercials (p. ex. manca de demanda i costos de producció relativament alts). Quan la retirada és per riscos de salut o danys a l'organisme, normalment hi haurà estat causat per efectes adversos inesperats que no van ser detectats durant assaigs clínics de III fase, i només es van fer evidents amb la vigilància posterior en períodes més llargs de temps.

Aquesta llista no es limita a fàrmacs que mai van ser aprovats pel FDA. Alguns d'ells (com el lumiracoxib, rimonabant, tolrestat, ximelagatran i ximelidina, per exemple) van ser aprovats per a ser comercialitzats en Europa però no es van aprovar als Estats Units quan els efectes secundaris van ser evidents i es van acabar per retirar del mercat.. Alguns fàrmacs d'aquesta llista (com l'LSD) mai van ser aprovats per a la seua comercialització.

Retirades significatives[modifica]

Nom del medicament Retirada País Notes
Adderall XR 2005 Canadà Risc d'ictus[1] La prohibició es va eliminar més tard perquè el risc de mort d'aquells que prenien Adderall XR no era superior a aquells que no en prenien.
Alatrofloxacin 2006 Arreu del món Malaltia de fetge fatal que porta a trasplant o mort.[2]
Alclofenac 1979 Regne Unit Vasculitis[3]
Alpidem (Ananxyl) 1995 Arreu del món No es va aprovar als EUA, es va retirar de França en 1994[4] i a la resta del món en 1995 per casos rars però greus d'hepatotoxicitat.[3][5]
Alosetron (Lotronex) 2000 EUA Efectes adversos gastrointestinals; colitis isquèmica; estrenyiment sever.[2] Reintrodït en 2002 de forma controlada[cal citació]
Altesin (=Amineptina d'alfaxoloa + alfadolona) 1984 França, Alemanya, Regne Unit Anafilaxi.[3]
Amineptina (Survector) 1999 França, EUA Hepatotoxicitat, efectes dermatològics, i potencial d'abús.[6]
Aminopirina 1999 França, Tailàndia Risc de agranulocitosi i acne sever.[3]
Amobarbital 1980 Noruega Risc de sobredosi.[3]
Amoproxan 1970 França Toxicitat dermatològica i oftalmològica.[3]
Acetat d'anagestona 1969 Alemanya Carcinogènsi animal.[3]
Antrafenina 1984 França Toxicitat sense especificar en experiments.[3]
Aprotinina (Trasylol) 2008 EUA Major risc de mort.[2]
Ardeparina (Normiflo) 2001 EUA Es va retirar per raons diferents a la seguretat o eficàcia.[7]
Astemizol (Hismanal) 1999 EUA, Malàsia, mercats inespecífics Arrítmia fatal[2][3]
Azaribina 1976 EUA Tromboembolisme.[3]
Bendazac 1993 Espanya Hepatotoxicitat.[3]
Benoxaprofen 1982 Alemanya, Espanya, Regne Unit, EUA Fallida de ronyó i fetge; sagnat gastrointestinal; úlceres.[2][3]
Benzarona 1992 Alemanya Hepatitis.[3]
Benziodarone 1964 França, Regne Unit Icterícia.[3]
Beta-etoxi-lacetanilanida 1986 Alemanya Toxicitat renal, carcinogènesi animal.[3]
Bezitramida 2004 Països Baixos Risc de sobredosi fatal.[8]
Bitionol 1967 EUA Toxicitat dermatològica.[3]
Brotizolam 1989 Regne Unit Carcinogènesi animal.[3]
Bromfenac 1998 EUA Hepatitis severa i fallida de fetge (exigint trasplant).[2]
Bucetin 1986 Alemanya Dany al ronyó.[3]
Buformin 1978 Alemanya Toxicitat metabòlica.[3]
Bunamiodil 1963 Canadà, Regne Unit, EUA Nefropatia.[9]
Butamben (Efocaine)(Butoforme) 1964 EUA Toxicitat dermatològica; reaccions psiquiàtriques.[3]
Canrenona 1986 Alemanya Carcinogènesi animal.[3]
Cerivastatina (Baycol, Lipobay) 2001 EUA Risc de rabdomiòlisi[2]
Clormadionan (Chlormenadione) 1970 Regne Unit, EUA Carcinogènesi animal.[3]
Clormezanona (Trancopal) 1996 Unió Europea, EUA, Sud-àfrica, Japó Hepatotoxicitat i síndrome d'Steven-Johnson.[3]
Clorfentermina 1969 Alemanya Toxicitat cardiovascular.[3]
Cianidanol 1985 França, Alemanya, Espanya, Suècia Anèmia hemolítica.[3]
Cinepazida 1988 Espanya Agranulocitosi.[10][11]
Cisaprida (Propulsid) 2000 EUA Risc d'arrítmies fatals.[2]
Clioquinol 1973 França, Alemanya, Regne Unit, EUA Neurotoxicitat.[3]
Clobutinol 2007 Alemanya Arrítmia ventricular, prolongació QT.ref name=Schubert-Zsilavecz>Schubert-Zsilavecz, Manfred «Arzneimittelrücknahmen Rückrufe im Rückblick». [Consulta: 25 setembre 2013].</ref>
Cloforex 1969 Alemanya Toxicitat cardiovascular.[3]
Clomacron 1982 Regne Unit Hepatotoxicitat.[3]
Clometacin 1987 França Hepatotoxicitat.[3]
Co-proxamol (Distalgesic) 2004 Regne Unit Risc de sobredosi
Ciclobarbital 1980 Noruega Risc de sobredosi[3]
Ciclofenil 1987 França Hepatotoxicitat.[3]
Dantron 1963 Canadà, Regne Unit, EUA Mutagènic.[12] Retirat de l'ús general al Regne Unit però permés en pacients terminals.
Dexfenfluramina 1997 Unió Europea, Regne Unit, EUA Cardiotòxic[3]
Propoxifen (Darvocet/Darvon) 2010 Arreu del món Augment del risc d'atacs del cor i ictus.[13]
Diacetoxidifenolisatin 1971 Austràlia Hepatotoxicitat.[3]
Dietilstilbestrol 1970s EUA Carcinogènic
Difemerina 1986 Alemanya Toxicitat multiorgànica.[3]
Dihidrostreptomicina 1970 EUA Reacció neuropsiquiàtrica.[3]
Dilevalol 1990 Regne Unit Hepatotoxicitat.[3]
Dimazole (Diamthazole) 1972 França, EUA Reacció neuropsiquiàtrica.[3]
Dimetilamilamina (DMAA) 1983 EUA Retirada voluntàriament del mercat per Lily.[14]:12 Reintroduïda com a suplement dietètic en 2006;[14]:13 i en 2013 la FDA la va voler eliminar per causar probelemes cardiovasculars[15]
Dinoprostona 1990 Regne Unit Hipotonia uterina, estrés fetal.[3]
Dipirona (Metamizole) 1975 Regne Unit, EUA, Altres Agranulocitosi, reaccions anafilàctiques. [3]
Iodida de ditiazanina 1964 França, EUA Reaccions cardiovasculars i metabòliques.[3]
Dofetilida 2004 Alemanya Interaccions amb altres medicaments, QT prolongat.[16]
Drotrecogina alfa (Xigris) 2011 Arreu del món Falta d'eficiència segons mostra l'estudi PROWESS-SHOCK[17][18][19]
Ebrotidina 1998 Espanya Hepatotoxicitat.[3]
Efalizumab (Raptiva) 2009 Alemanya Retirat pel risc aumentat de leucoenfepalotia progressiva multifocal.[16]
Encainide 1991 Regne Unit, EUA Ventricular arrhythmias.[2][3]
Ethyl carbamate 1963 Canadà, Regne Unit, EUA, Carcinogen.[20]
Etretinate 1989 França Teratogen.[2][3]
Exifone 1989 França Hepatotoxicitat.[3]
Fen-phen (popular combination of fenfluramine and phentermine) 1997 Cardiotoxicity
Fenclofenac 1984 Regne Unit Cutaneous reactions; animal carcinogenicity.[3]
Fenclozic acid 1970 Regne Unit, EUA Hepatotoxicitat.[3]
Fenfluramine 1997 European Union, Regne Unit, EUA, India, South Africa, others Cardiac valvular disease, pulmonary hypertension, cardiac fibrosis;[3][21] 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 Alemanya, Regne Unit Cutaneous reaction, multiorgan toxicity.[3]
Fipexide 1991 França Hepatotoxicitat.[3]
Flosequinan (Manoplax) 1993 Regne Unit, EUA Increased mortality at higher doses; increased hospitalizations.[2][3]
Flunitrazepam 1991 França Abuse.[3]
Flupirtine 2018 European Union Liver toxicity.[22]
Gatifloxacin 2006 EUA Increased risk of dysglycemia.[2]
Gemtuzumab ozogamicin (Mylotarg) 2010 EUA No improvement in clinical benefit; risk for death.[2] Returned to market in 2017. [23]
Glafenine 1984 França, Germany Anaphylaxis.[3]
Grepafloxacin (Raxar) 1999 Withdrawn Germany, Regne Unit, EUA 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 Regne Unit Hepatotoxicitat, jaundice.[3]
Indalpine 1985 França Agranulocytosis.[3]
Indoprofen 1983 Alemanya, Spain, Regne Unit Animal carcinogenicity, gastrointestinal toxicity.[3]
Ingenol mebutate gel 2020 Suspended in Europe Increased risk of skin cancers.[24][25]
Iodinated casein strophantin 1964 EUA Metabolic reaction.[3]
Iproniazid 1964 Canadà Interactions with food products containing tyrosine.[26]
Isaxonine phosphate 1984 França Hepatotoxicitat.[3]
Isoxicam 1983 França, Germany, Spain, others Stevens johnson syndrome.[3]
Kava Kava 2002 Alemanya Hepatotoxicitat.[16]
Ketorolac 1993 França, Germany, others Hemorrhage, Kidney Failure.[3]
L-tryptophan 1989 Alemanya, Regne Unit 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.[27][28][29]
Levomethadyl acetate 2003 EUA Cardiac arrhythmias and cardiac arrest.[2]
Lorcaserin (Belviq) 2020 EUA Increased risk of cancer. [30]
Lumiracoxib (Prexige) 2007–2008 Arreu del món 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 Regne Unit Hepatotoxicitat, drug intereaction.[3]
Methandrostenolone 1982 França, Germany, Regne Unit, EUA, others Off-label abuse.[3]
Methapyrilene 1979 Alemanya, Regne Unit, EUA Animal carcinogenicity.[3]
Methaqualone 1984 South Africa (1971), India (1984), United Nations (1971–1988) Withdrawn because of risk of addiction and overdose[31][32]
Metipranolol 1990 Regne Unit, others Uveitis.[3]
Metofoline 1965 EUA Unspecific experimental toxicity.[3]
Mibefradil 1998 European Union, Malaysia, EUA, others Fatal arrhythmia, drug interactions.[2][3]
Minaprine 1996 França Convulsions.[3]
Moxisylyte 1993 França Necrotic hepatitis.[3]
Muzolimine 1987 França, Germany, European Union Polyneuropathy.[3]
Natalizumab (Tysabri) 2005–2006 EUA Voluntarily withdrawn from US market because of risk of Progressive multifocal leukoencephalopathy (PML). Returned to market July, 2006.
Nefazodone 2007 EUA, Canada, others Branded version withdrawn by originator in several countries in 2007 for Hepatotoxicitat. Generic versions available.[33]
Nialamide 1974 Regne Unit, EUA Hepatotoxicitat, drug intereaction.[3]
Nikethamide 1988 multiple markets CNS Stimulation.[3]
Nitrefazole 1984 Alemanya Hepatic and hematologic toxicity.[3]
Nomifensine 1981–1986 França, Germany, Spain, Regne Unit, EUA, others Hemolytic Anemia, Hepatotoxicitat, serious hypersensitive reactions.[2][3]
Oxeladin 1976 Canadà, Regne Unit, EUA (1976) Carcinogen.[34]
Oxyphenbutazone 1984–1985 Regne Unit, EUA, Germany, France, Canada Bone marrow suppression, Stevens–Johnson syndrome.[3][35][36]
Oxyphenisatin (Phenisatin) Australia, France, Germany, Regne Unit, EUA Hepatotoxicitat.[3]
Ozogamicin 2010 EUA No improvement in clinical benefit; risk for death; veno-occlusive disease.[2]
Pemoline (Cylert) 1997 Canadà, Regne Unit Withdrawn from US in 2005. Hepatotoxicitat[37] Reason:Hepatotoxicitat.[3]
Pentobarbital 1980 Noruega Risk of fatal overdose[3]
Pentylenetetrazol 1982 EUA Withdrawn for inability to produce effective convulsive therapy, and for causing seizures.
Pergolide (Permax) 2007 EUA Risk for heart valve damage.[2]
Perhexiline 1985 Regne Unit, Spain Neurologic and hepatic toxicity.[3]
Phenacetin 1975 Canadà An ingredient in "A.P.C." tablet; withdrawn because of risk of cancer and kidney disease[38] Germany Denmark, Regne Unit, EUA, others Reason: nephropathy.[3]
Phenformin and Buformin 1977 França, Germany US Severe lactic acidosis[3]
Phenolphthalein 1997 EUA Possible carcinogen.[39]
Phenoxypropazine 1966 Regne Unit Hepatotoxicitat, drug intereaction.[3]
Phenylbutazone 1985 Alemanya Off-label abuse, hematologic toxicity.[3]
Phenylpropanolamine (Propagest, Dexatrim) 2000 Canadà, EUA Hemorrhagic stroke.[40][41]
Pifoxime (=Pixifenide) 1976 França Neuropsychiatric reaction.[3]
Pirprofen 1990 França, Germany, Spain Liver toxicity.[3][10]:223
Prenylamine 1988 Canadà, France, Germany, Regne Unit, EUA, others Cardiac arrythmia[42] and death.[3]
Proglumide 1989 Alemanya Respiratory reaction.[3]
Pronethalol 1965 Regne Unit Animal carcinogenicity.[3]
Propanidid 1983 Regne Unit Allergy.[3]
Proxibarbal 1998 Spain, France, Italy, Portugal, Turkey Immunoallergic, thrombocytopenia.[3]
Pyrovalerone 1979 França Abuse.[3]
Rapacuronium (Raplon) 2001 EUA, multiple markets Withdrawn in many countries because of risk of fatal bronchospasm[2]
Remoxipride 1993 Regne Unit, others Aplastic anemia.[3]
rhesus rotavirus vaccine-tetravalent (RotaShield) 1999 EUA Withdrawn due to risk of intussusception[43]
Rimonabant (Acomplia) 2008 Arreu del món Risk of severe depression and suicide[16]
Rofecoxib (Vioxx) 2004 Arreu del món 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 França, Norway, others. Risk of overdose[3]
Sertindole 1998 European Union Arrhythmia and sudden cardiac death[3][44]
Sibutramine (Reductil/Meridia) 2010 Australia,[45] Canada,[46] China,[47] the European Union (EU),[48] Hong Kong,[49] India,[50] Mexico, New Zealand,[51] the Philippines,[52] Thailand,[53] the United Kingdom,[54] and the United States[55] Increased risk of heart attack and stroke.[2]
Sitaxentan 2010 Alemanya Hepatotoxicitat.[16]
Sorivudine 1993 Japan Drug interaction and deaths.[56]
Sparfloxacin 2001 EUA QT prolongation and phototoxicity.[2]
Sulfacarbamide 1988 Alemanya Dermatologic, hematologic and hepatic reactions.[3]
Sulfamethoxydiazine 1988 Alemanya Unknown.[3]
Sulfamethoxypyridazine 1986 Regne Unit Dermatologic and hematologic reactions.[3]
Suloctidil 1985 Alemanya, France, Spain Hepatotoxicitat.[3]
Suprofen 1986–1987 Regne Unit, Spain, EUA Kidney damage.[2][3]
Tegaserod (Zelnorm) 2007 EUA 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 Alemanya, Regne Unit, EUA, others Low blood sugar; hemolytic anemia; kidney, liver dysfunction; allergic reactions[2][3]
Temafloxacin 1992 EUA 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 França, South Africa, Oman, others, EUA Prolonged QT interval; ventricular tachycardia[2][3]
Terodiline (Micturin) 1991 Alemanya, Regne Unit, Spain, others Prolonged QT interval, ventricular tachycardia and arrhythmia.[3]
Tetrazepam 2013 European Union Serious cutaneous reactions.[57]
Thalidomide 1961 Alemanya Withdrawn because of risk of teratogenicity;[58] returned to market for use in leprosy and multiple myeloma under FDA orphan drug rules
Thenalidine 1963 Canadà, Regne Unit, EUA Neutropenia[3][59]
Thiobutabarbitone 1993 Alemanya Kidney injury.[3]
Thioridazine (Melleril) 2005 Alemanya, Regne Unit Withdrawn worldwide due to severe cardiac arrhythmias[60][61]
Ticrynafen (Tienilic acid) 1980 Alemanya, France, Regne Unit, EUA others Liver toxicity and death.[3]
Tolcapone (Tasmar) 1998 European Union, Canada, Australia Hepatotoxicitat[3]
Tolrestat (Alredase) 1996 Argentina, Canada, Italy, others Severe Hepatotoxicitat[3]
Triacetyldiphenolisatin 1971 Australia Hepatotoxicitat.[3]
Triazolam 1991 França, Netherlands, Finland, Argentina, Regne Unit others Psychiatric adverse drug reactions, amnesia.[3][62]
Triparanol 1962 França, EUA Cataracts, alopecia, ichthyosis.[3]
Troglitazone (Rezulin) 2000 EUA, Germany Hepatotoxicitat[2]
Trovafloxacin (Trovan) 1999–2001 European Union, EUA Withdrawn because of risk of liver failure[2][3]
Valdecoxib (Bextra) 2004 EUA Risk of heart attack and stroke.[2]
Vincamine 1987 Alemanya Hematologic toxicity.[3]
Xenazoic acid 1965 França Hepatotoxicitat.[3]
Ximelagatran (Exanta) 2006 Alemanya Hepatotoxicitat[16]
Zimelidine 1983 Arreu del món Risk of Guillain–Barré syndrome, hypersensitivity reaction, Hepatotoxicitat[3][63][64] banned worldwide.[65]
Zomepirac 1983 Regne Unit, Germany, Spain, EUA Anaphylactic reactions and non-fatal allergic reactions, kidney failure[2][3]

Vegeu també[modifica]

Referències[modifica]

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