List of withdrawn drugs

Short description: None

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Drugs or medicines may be withdrawn from commercial markets because of risks to patients, but also because of commercial reasons (e.g. lack of demand and relatively high production costs).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* 2 Withdrawn clinical trial drugs
* 3 See also
* 4 References
* 5 External links

## Significant withdrawals

Drug name  | Withdrawn  | Country  | Remarks

|
|
|

Amphetamine Mix (Adderall XR)  | 2005  | Canada  | Withdrawn over reports of increased risk of stroke, reinstated after increased risk not found.[1]
Alatrofloxacin | 2006  | Worldwide  | Serious hepatotoxicity leading to liver transplant or death.[2]
Alclofenac | 1979  | UK  | Vasculitis[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Alpidem (Ananxyl)  | 1995  | Worldwide  | Not approved in the US, withdrawn in France in 1994[4] and the rest of the market in 1995 because of rare but serious hepatotoxicity.[3][5]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 with restricted indication and new controls.[6]
Alphaxolone/Alphadolone (Althesin)  | 1984  | France, Germany, UK  | Anaphylaxis, possibly due to carrier oil (Cremophor EL).[3]
Amineptine (Survector)  | 1999  | France, US  | Hepatotoxicity, dermatological side effects, and abuse potential.[7]
Aminopyrine  | 1999  | France, Thailand  | Risk of agranulocytosis and severe acne.[3]
Amobarbital | 1980  | Norway  | Risk of barbiturate toxicity.[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  | Withdrawn at request of NDA originator, "not for reason of safety or efficacy."[8][9]
Astemizole (Hismanal)  | 1999  | US, Malaysia, Multiple Nonspecified Markets  | Fatal arrhythmia[2][3]
Azaribine | 1976  | US  | Thromboembolism.[3]
Bendazac | 1993  | Spain  | Hepatotoxicity.[3]
Benoxaprofen (Oraflex, Opren)  | 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[10]
Bithionol | 1967  | US  | Dermatologic toxicity.[3]
Brotizolam | 1989  | UK  | Animal carcinogenicity.[3]
Bromfenac | 1998  | US  | Severe hepatitis and liver failure (requiring transplantation).[2]
Bucetin | 1986  | Germany  | Kidney damage[3]
Buformin | 1978  | Germany  | Metabolic toxicity.[3]
Bunamiodyl  | 1963  | Canada, UK, US  | Nephropathy.[11]
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 and Stevens–Johnson Syndrome[3]
Chlorphentermine | 1969  | Germany  | Cardiovascular Toxicity.[3]
Cianidanol  | 1985  | France, Germany, Spain, Sweden  | Hemolytic Anemia.[3]
Cinepazide | 1988  | Spain  | Agranulocytosis.[12][13]
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.[14]
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.[15] 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.[16]
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.[17]:12 Reintroduced as a dietary supplement in 2006;[17]:13 in 2013 the FDA started work to ban it due to cardiovascular problems[18]
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.[14]
Drotrecogin alfa (Xigris)  | 2011  | Worldwide  | Lack of efficacy as shown by PROWESS-SHOCK study[19][20][21]
Ebrotidine | 1998  | Spain  | Hepatotoxicity.[3]
Efalizumab (Raptiva)  | 2009  | Germany  | Withdrawn because of increased risk of progressive multifocal leukoencephalopathy[14]
Encainide | 1991  | UK, US  | Ventricular arrhythmias.[2][3]
Ethyl carbamate | 1963  | Canada, UK, US  | Carcinogen.[22]
Etretinate | 1989  | France  | Teratogen.[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][23] 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  | 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.[24]
Gatifloxacin | 2006  | US  | Increased risk of dysglycemia.[2]
Gemtuzumab ozogamicin (Mylotarg)  | 2010  | US  | No improvement in clinical benefit; risk for death.[2] Returned to market in 2017.[25]
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]
Ingenol mebutate gel  | 2020  | Suspended in Europe  | Increased risk of skin cancers.[26][27]
Iodinated casein strophantin  | 1964  | US  | Metabolic reaction.[3]
Iproniazid | 1964  | Canada  | Interactions with food products containing tyrosine.[28]
Isaxonine phosphate  | 1984  | France  | Hepatotoxicity.[3]
Isoxicam | 1983  | France, Germany, Spain, others  | Stevens–Johnson syndrome.[3]
Kava Kava  | 2002  | Germany  | Hepatotoxicity.[14]
Ketorolac | 1993  | France, Germany, others  | Hemorrhage, Kidney 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.[29][30][31]
Levomethadyl acetate  | 2003  | US  | Cardiac arrhythmias and cardiac arrest.[2]
Lorcaserin (Belviq)  | 2020  | US  | Increased risk of cancer.[32]
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[33][34]
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 | 2004  | Europe, Australia, New Zealand and Canada[35][36][37] | Branded version withdrawn by originator in several countries in 2007 for hepatotoxicity. Generic versions available. Still available in US market.
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)  | Carcinogen.[38]
Oxyphenbutazone | 1984–1985  | UK, US, Germany, France, Canada  | Bone marrow suppression, Stevens–Johnson syndrome.[3][39][40]
Oxyphenisatin (Phenisatin)  | 1970s  | 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 due to hepatotoxicity.[41][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[42] Germany Denmark, UK, US, others Reason: nephropathy.[3]
Phenformin and Buformin | 1977  | France, Germany US  | Severe lactic acidosis[3]
Phenolphthalein | 1997  | US  | Possible carcinogen.[43]
Phenoxypropazine | 1966  | UK  | Hepatotoxicity, drug intereaction.[3]
Phenylbutazone | 1985  | Germany  | Off-label abuse, hematologic toxicity.[3]
Phenylpropanolamine (Propagest, Dexatrim)  | 2000  | Canada, US  | Hemorrhagic stroke.[44][45]
Pifoxime (=Pixifenide)  | 1976  | France  | Neuropsychiatric reaction.[3]
Pirprofen | 1990  | France, Germany, Spain  | Liver toxicity.[3][12]:223
Prenylamine | 1988  | Canada, France, Germany, UK, US, others  | Cardiac arrythmia[46] 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]
Ranitidine (Zantac)  | 2020  | Worldwide  | Found to spontaneously break down into the carcinogen N-nitrosodimethylamine.
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.[47]
Rimonabant (Acomplia)  | 2008  | Worldwide  | Risk of severe depression and suicide.[14]
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][48]
Sibutramine (Reductil/Meridia)  | 2010  | Australia,[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] and the United States[59] | Increased risk of heart attack and stroke.[2]
Sitaxentan | 2010  | Germany  | Hepatotoxicity.[14]
Sorivudine | 1993  | Japan  | Drug interaction and deaths.[60]
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; returned to market in 2019.
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.[61]
Thalidomide | 1961  | Germany  | Withdrawn because of risk of teratogenicity;[62] returned to market for use in leprosy and multiple myeloma under FDA orphan drug rules
Thenalidine | 1963  | Canada, UK, US  | Neutropenia[3][63]
Thiobutabarbitone  | 1993  | Germany  | Kidney injury.[3]
Thioridazine (Melleril)  | 2005  | Germany, UK  | Withdrawn worldwide due to severe cardiac arrhythmias[64][65] Continues to be available in Russia.
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][66]
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[14]
Zimelidine | 1983  | Worldwide  | Risk of Guillain–Barré syndrome, hypersensitivity reaction, hepatotoxicity[3][67][68] banned worldwide.[69]
Zomepirac | 1983  | UK, Germany, Spain, US  | Anaphylactic reactions and non-fatal allergic reactions, kidney failure[2][3]

## Withdrawn clinical trial drugs

* RG7795, in 2021 discontinued development[70]

## See also

* Adverse drug reaction
* Adverse events
* European Medicines Agency
* Food and Drug Administration

## References

1. ↑ Branch, Government of Canada, Health Canada, Public Affairs, Consultation and Communications. "Health Canada – Home Page". http://www.hc-sc.gc.ca/english/protection/warnings/2005/2005_01.html.
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 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. ↑ 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 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". http://whqlibdoc.who.int/druginfo/DRUG_INFO_8_2_1994.pdf.
5. ↑ Berson, A (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. PMID 11602696. http://jpet.aspetjournals.org/content/299/2/793.full.pdf.
6. ↑ Grady, Denise (2002-06-08). "U.S. Lets Drug Tied to Deaths Back on Market" (in en-US). The New York Times. ISSN 0362-4331. https://www.nytimes.com/2002/06/08/us/us-lets-drug-tied-to-deaths-back-on-market.html.
7. ↑ DrugBank. "Amineptine". http://www.drugbank.ca/drugs/DB04836.
8. ↑ "Determination That Ardeparin Sodium Injection Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness". 2002-05-23. https://www.federalregister.gov/documents/2002/05/23/02-12874/determination-that-ardeparin-sodium-injection-was-not-withdrawn-from-sale-for-reasons-of-safety-or.
9. ↑ "FDA Response to Citizen Request re Ardeparin". https://www.fda.gov/ohrms/dockets/98fr/052302b.htm.
10. ↑ DrugBank. "Bezitramide". http://www.drugbank.ca/drugs/DB01459.
11. ↑ DrugBank. "Bunamiodyl". http://www.drugbank.ca/drugs/DB04814.
12. ↑ 12.0 12.1 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
13. ↑ 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
14. ↑ 14.0 14.1 14.2 14.3 14.4 14.5 14.6 Schubert-Zsilavecz, Manfred (2011). "Arzneimittelrücknahmen Rückrufe im Rückblick". Pharmazeutische Zeitung (German). http://www.pharmazeutische-zeitung.de/index.php?id=38778.
15. ↑ DrugBank. "Dantron". http://www.drugbank.ca/drugs/DB04816.
16. ↑ "Press Announcements – Xanodyne agrees to withdraw propoxyphene from the U.S. market". https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm234350.htm.
17. ↑ 17.0 17.1 Col John Lammie et al. Report of the Department Of Defense: 1,3 Dimethylamylamine (Dmaa) Safety Review Panel June 3, 2013
18. ↑ FDA. "Stimulant Potentially Dangerous to Health, FDA Warns". https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm347270.htm.
19. ↑ Drotrecogin Alfa (Activated) in Adults with Septic Shock  , N Engl J Med 2012; 366:2055–2064, May 31, 2012, doi:10.1056/NEJMoa1202290
20. ↑ "Xigris (drotrecogin alfa (activated)) to be withdrawn due to lack of efficacy". Press release. London, UK: European Medicines Agency. 25 October 2011. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/10/news_detail_001373.jsp&mid=WC0b01ac058004d5c1.
21. ↑ Armstrong, Drew (25 October 2011). "Lilly Pulls Xigris Off Markets After Sepsis Drug Fails Study". http://www.businessweek.com/news/2011-10-25/lilly-pulls-xigris-off-markets-after-sepsis-drug-fails-study.html.
22. ↑ DrugBank. "Ethyl carbamate". http://www.drugbank.ca/drugs/DB04827.
23. ↑ DrugBank. "Fenfluramine". http://www.drugbank.ca/drugs/DB00574.
24. ↑ "Withdrawal of pain medicine flupirtine endorsed". http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/03/news_detail_002930.jsp&mid=WC0b01ac058004d5c1.
25. ↑ FDA. "FDA approves Mylotarg for treatment of acute myeloid leukemia". https://www.fda.gov/news-events/press-announcements/fda-approves-mylotarg-treatment-acute-myeloid-leukemia.
26. ↑ European medicines Agency. "EMA suspends Picato as a precaution while review of skin cancer risk continues". https://www.ema.europa.eu/en/documents/referral/picato-article-20-referral-ema-suspends-picato-precaution-while-review-skin-cancer-risk-continues_en.pdf.
27. ↑ "Ingenol mebutate gel (Picato▼): Increased incidence of skin tumours seen in some clinical studies". https://www.gov.uk/drug-safety-update/ingenol-mebutate-gel-picato-increased-incidence-of-skin-tumours-seen-in-some-clinical-studies.
28. ↑ DrugBank. "Iproniazid". http://www.drugbank.ca/drugs/DB04818.
29. ↑ Centers for Disease Control and Prevention (CDC) (December 2009). "Agranulocytosis associated with cocaine use – four States, March 2008 – November 2009". Morb. Mortal. Wkly. Rep. 58 (49): 1381–5. PMID 20019655. https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5849a3.htm.
30. ↑ Nancy Y Zhu; Donald F. LeGatt; A Robert Turner (February 2009). "Agranulocytosis After Consumption of Cocaine Adulterated With Levamisole". Annals of Internal Medicine 150 (4): 287–289. doi:10.7326/0003-4819-150-4-200902170-00102. PMID 19153405.
31. ↑ Kinzie, Erik (April 2009). "Levamisole Found in Patients Using Cocaine". Annals of Emergency Medicine 53 (4): 546–7. doi:10.1016/j.annemergmed.2008.10.017. PMID 19303517. http://www.mdconsult.com/das/article/body/154945316-2/jorg=journal&source=&sp=21877276&sid=0/N/691072/1.html?issn=01960644. Retrieved 2009-08-18.
32. ↑ FDA (13 February 2020). "FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market". FDA. https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-weight-loss-drug-belviq-belviq-xr-lorcaserin-market. Retrieved 17 February 2020.
33. ↑ Central Drugs Standard Control Organization. "Drugs Banned In India". Ministry of Health and Family Welfare, Government of India. http://cdsco.nic.in/html/drugsbanned.html.
34. ↑ "Drug Effects – Methaqualone". South African Police Service. http://www.saps.gov.za/drugs/meth.htm.
35. ↑ Cosgrove-Mather, Bootie (December 5, 2007). "Anti-Depressant Taken Off Market". CBS NEWS. http://www.cbsnews.com/8301-18563_162-612150.html.
36. ↑ Babai, S; Auclert, L; Le-Louët, H (November 2021). "Safety data and withdrawal of hepatotoxic drugs.". Therapie 76 (6): 715-723. doi:10.1016/j.therap.2018.02.004. PMID 29609830.
37. ↑ Lexchin, Joel (15 March 2005). "Drug withdrawals from the Canadian market for safety reasons, 1963–2004" (in en). pp. 765–767. doi:10.1503/cmaj.045021. https://www.cmaj.ca/content/172/6/765.
38. ↑ DrugBank. "Oxeladin". http://www.drugbank.ca/drugs/DB04822.
39. ↑ DrugBank. "Oxyphenbutazone". http://www.drugbank.ca/drugs/DB03585.
40. ↑ Biron, P (15 May 1986). "Withdrawal of oxyphenbutazone: what about phenylbutazone?". CMAJ: Canadian Medical Association Journal 134 (10): 1119–20. PMID 3697857.
41. ↑ DrugBank. "Pemoline". http://www.drugbank.ca/drugs/DB01230.
42. ↑ DrugBank. "Phenacetin". http://www.drugbank.ca/drugs/DB03783.
43. ↑ Wysowski, Diane K.; Swartz, L (2005). "Adverse Drug Event Surveillance and Drug Withdrawals in the United States, 1969–2002: The Importance of Reporting Suspected Reactions". Archives of Internal Medicine 165 (12): 1363–9. doi:10.1001/archinte.165.12.1363. PMID 15983284.
44. ↑ Commissioner, Office of the. "Safety Alerts for Human Medical Products – Phenylpropanolamine hydrochloride (PPA)". https://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm172959.htm.
45. ↑ DrugBank. "Phenylpropanolamine". http://www.drugbank.ca/drugs/DB00397.
46. ↑ DrugBank. "Prenylamine". http://www.drugbank.ca/drugs/DB04825.
47. ↑ "Withdrawal of Rotavirus Vaccine Recommendation". https://www.cdc.gov/mmwr/preview/mmwrhtml/mm4843a5.htm.
48. ↑ DrugBank. "Sertindole". http://www.drugbank.ca/drugs/DB06144.
49. ↑ "Sibutramine (brand name Reductil) Information – Australia". Abbott Laboratories. 2010. http://sibutramine.com/australia/en-au/.
50. ↑ Health Canada Endorsed Important Safety Information on MERIDIA (Sibutramine Hydrochloride Monohydrate) : Subject: Voluntary withdrawal of Meridia (sibutramine) capsules from the Canadian market.
51. ↑ "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. http://www.sda.gov.cn/WS01/CL0195/55333.html.
52. ↑ (in German) Sibutramin-Vertrieb in der Europäischen Union ausgesetzt [1]. Abbott Laboratories in Germany. Press Release 2010-01-21. Retrieved 2010-01-27
53. ↑ "De-registration of pharmaceutical products containing sibutramine" (Press release). info.gov in Hong Kong. November 2, 2010. Archived from the original on October 21, 2011. Retrieved 2010-11-08.
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. http://business.inquirer.net/159883/fda-warns-online-sellers-of-banned-slimming-pills.
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.
58. ↑ "Top obesity drug sibutramine being suspended". BBC News. 2010-01-22. http://news.bbc.co.uk/1/hi/health/8473555.stm.
59. ↑ Rockoff, Jonathan D.; Dooren, Jennifer Corbett (October 8, 2010). "Abbott Pulls Diet Drug Meridia Off US Shelves". The Wall Street Journal. https://online.wsj.com/article/BT-CO-20101008-710904.html.
60. ↑ H. Gurdon: Japan bans shingles drug after deaths BMJ 1994;309:627
61. ↑ Paar, W.D; Müller-Jakic. "Ruhen der Zulassung Tetrazepam haltiger Arzneimittel in der EU (German)". Sanofi-Aventis Deutschland GmbH. http://www.akdae.de/Arzneimittelsicherheit/RHB/20130624.pdf.
62. ↑ Luippold, Gerd (2006). "Renaissance des Contergan-Wirkstoffs". Pharmazeutische Zeitung (German). http://www.pharmazeutische-zeitung.de/index.php?id=586.
63. ↑ Drugbank. "Thenalidine". http://www.drugbank.ca/drugs/DB04826.
64. ↑ Purhonen, M; Koponen, H; Tiihonen, J; Tanskanen, A (November 2012). "Outcome of patients after market withdrawal of thioridazine: A retrospective analysis in a nationwide cohort". Pharmacoepidemiology and Drug Safety 21 (11): 1227–1231. doi:10.1002/pds.3346. PMID 22941581.
65. ↑ "SHARED CARE PROTOCOL Thioridazine". NHS Lothian Joint Formulary. March 2012. http://www.ljf.scot.nhs.uk/SharedCareofMedicines/Shared Care Agreements/SCA/SCA Thioridazine v1 0 Final.pdf.
66. ↑ DrugBank. "Triazolam". http://www.drugbank.ca/drugs/DB00897.
67. ↑ Fagius, J.; Osterman, P. O.; Sidén, A.; Wiholm, B. E. (1985). "Guillain-Barré syndrome following zimeldine treatment". Journal of Neurology, Neurosurgery, and Psychiatry 48 (1): 65–69. doi:10.1136/jnnp.48.1.65. PMID 3156214.
68. ↑ Pubchem record says "withdrawn in 1983"
69. ↑ DrugBank. "Zimelidine". http://www.drugbank.ca/drugs/DB04832.
70. ↑ Sachin Bhagchandani, Jeremiah A.Johnson, and Darrell J.Irvine (2021). "Evolution of Toll-like receptor 7/8 agonist therapeutics and their delivery approaches: From antiviral formulations to vaccine adjuvants". Advanced Drug Delivery Reviews 175: 113803. doi:10.1016/j.addr.2021.05.013. PMID 34058283.

## External links

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

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