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List of withdrawn drugs









List of withdrawn drugs


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Drugs or medicines may be withdrawn from commercial markets because of risks to patients, but also because of commercial reasons (e.g. lack of demand and relatively high production costs).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


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.




Contents






  • 1 Significant withdrawals


  • 2 See also


  • 3 References


  • 4 External links





Significant withdrawals[edit]









































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































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Withdrawn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
Risk of overdose.[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
Risk of 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
Kidney damage[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 [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
Risk of overdose

Cyclobarbital
1980
Norway
Risk of overdose[3]

Cyclofenil
1987
France
Hepatotoxicity.[3]

Dantron
1963
Canada, UK, US

Mutagenic.[13] withdrawn from general use in UK but permitted in terminal patients

Dexfenfluramine
1997
European Union, UK, US

Cardiotoxic[3]

Propoxyphene (Darvocet/Darvon)
2010
Worldwide
Increased risk of heart attacks and stroke.[14]

Diacetoxydiphenolisatin
1971
Australia
Hepatotoxicity.[3]

Diethylstilbestrol
1970s
US
Carcinogen

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
Hepatotoxicity.[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]

Flupirtine
2018
European Union
Liver toxicity.[22]

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.[23]

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.[24][25][26]

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[27][28]

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.[29]

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.[30]

Oxyphenbutazone
1984–1985
UK, US, Germany, France, Canada
Bone marrow suppression, Stevens–Johnson syndrome.[3][31][32]

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[33] Reason:hepatotoxicity.[3]

Pentobarbital
1980
Norway
Risk of fatal overdose[3]

Pentylenetetrazol
1982
US
Withdrawn for inability to produce effective convulsive therapy, and for causing seizures.

Pergolide (Permax)
2007
US
Risk for heart valve damage.[2]

Perhexiline
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[34] Germany Denmark, UK, US, others Reason: nephropathy.[3]

Phenformin and Buformin
1977
France, Germany US
Severe lactic acidosis[3]

Phenolphthalein
1997
US
Carcinogenicity.[35]

Phenoxypropazine
1966
UK
Hepatotoxicity, drug intereaction.[3]

Phenylbutazone
1985
Germany
Off-label abuse, hematologic toxicity.[3]

Phenylpropanolamine (Propagest, Dexatrim)
2000
Canada, US
Hemorrhagic stroke.[36][37]

Pifoxime (=Pixifenide)
1976
France
Neuropsychiatric reaction.[3]

Pirprofen
1990
France, Germany, Spain
Liver toxicity.[3][10]:223

Prenylamine
1988
Canada, France, Germany, UK, US, others
Cardiac arrythmia[38] 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]
rhesus rotavirus vaccine-tetravalent (RotaShield)
1999
US
Withdrawn due to risk of intussusception[39]

Rimonabant (Acomplia)
2008
Worldwide
Risk of severe depression and suicide[12]

Rofecoxib (Vioxx)
2004
Worldwide
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

France, Norway, others.
Risk of overdose[3]

Sertindole
1998
European Union
Arrhythmia and sudden cardiac death[3][40]

Sibutramine (Reductil/Meridia)
2010
Australia,[41] Canada,[42] China,[43] the European Union (EU),[44] Hong Kong,[45] India,[46] Mexico, New Zealand,[47] the Philippines,[48] Thailand,[49] the United Kingdom,[50] and the United States[51]
Increased risk of heart attack and stroke.[2]

Sitaxentan
2010
Germany
Hepatotoxicity.[12]

Sorivudine
1993
Japan
Drug interaction and deaths.[52]

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]

Suloctidil
1985
Germany, France, Spain
Hepatotoxicity.[3]

Suprofen
1986–1987
UK, Spain, US
Kidney damage.[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.[53]

Thalidomide
1961
Germany
Withdrawn because of risk of teratogenicity;[54] returned to market for use in leprosy and multiple myeloma under FDA orphan drug rules

Thenalidine
1963
Canada, UK, US
Neutropenia[3][55]

Thiobutabarbitone
1993
Germany
Renal insufficiency.[3]

Thioridazine (Melleril)
2005
Germany, UK
Withdrawn worldwide due to severe cardiac arrhythmias[56][57]

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][58]

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][59][60] banned worldwide.[61]

Zomepirac
1983
UK, Germany, Spain, US

Anaphylactic reactions and non-fatal allergic reactions, renal failure[2][3]


See also[edit]



  • Adverse drug reaction

  • Adverse events

  • European Medicines Agency

  • Food and Drug Administration



References[edit]





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External links[edit]



  • CDER Report to the Nation: 2005 Has a list of US withdrawals through 2005.





Retrieved from "https://en.wikipedia.org/w/index.php?title=List_of_withdrawn_drugs&oldid=854527428"





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