Drugs or medicines may be withdrawn from commercial markets because of risks to patients, but also because of commercial reasons (e.g. lack of demand and relatively high production costs).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.
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Drug name | Withdrawn | Country | Remarks |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Amphetamine Mix (Adderall XR) | 2005 | Canada | Withdrawn over reports of increased risk of stroke, reinstated after increased risk not found.[1] |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Alpidem (Ananxyl) | 1995 | Worldwide | Not approved in the US, withdrawn in France in 1994[4] and the rest of the market in 1995 because of rare but serious hepatotoxicity.[3][5] |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Ardeparin (Normiflo) | 2001 | US | Withdrawn at request of NDA originator, "not for reason of safety or efficacy."[8][9] |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. |
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
See also
References
- ↑ Branch, Government of Canada, Health Canada, Public Affairs, Consultation and Communications. "Health Canada – Home Page". Archived from the original on 28 June 2005. Retrieved 28 November 2016.
{{cite web}}
: CS1 maint: multiple names: authors list (link) - 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 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. S2CID 23821961.
- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 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. S2CID 73036562.
- ↑ "WHO Drug Information Vol. 8, No. 2, 1994, page 64" (PDF). Archived from the original (PDF) on 3 March 2012. Retrieved 28 November 2016.
- ↑ 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" (PDF). J Pharmacol Exp Ther. 299 (2): 793–800. PMID 11602696.
- ↑ Grady, Denise (2002-06-08). "U.S. Lets Drug Tied to Deaths Back on Market". The New York Times. ISSN 0362-4331. Retrieved 2021-07-20.
- ↑ DrugBank. "Amineptine". Archived from the original on 27 September 2013. Retrieved 24 September 2013.
- ↑ "Determination That Ardeparin Sodium Injection Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness". Federal Register. 2002-05-23. Retrieved 2021-07-20.
- ↑ "FDA Response to Citizen Request re Ardeparin". fda.gov. Archived from the original on 18 January 2017. Retrieved 28 April 2018.
- ↑ DrugBank. "Bezitramide". Archived from the original on 27 September 2013. Retrieved 24 September 2013.
- ↑ DrugBank. "Bunamiodyl". Archived from the original on 27 September 2013. Retrieved 24 September 2013.
- 1 2 WHO. Consolidated List of Products – Whose Consumption and/or Sale Have Been Banned, Withdrawn, Severely Restricted or Not Approved by Governments, Twelfth Issue – Pharmaceuticals Archived 2014-11-09 at Wikiwix. United Nations – New York, 2005
- ↑ 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 Archived 2012-10-23 at the Wayback Machine United Nations – New York, 2005
- 1 2 3 4 5 6 7 Schubert-Zsilavecz, Manfred (2011). "Arzneimittelrücknahmen Rückrufe im Rückblick". Pharmazeutische Zeitung (German). Archived from the original on 27 September 2013. Retrieved 25 September 2013.
- ↑ DrugBank. "Dantron". Archived from the original on 27 September 2013. Retrieved 24 September 2013.
- ↑ "Press Announcements – Xanodyne agrees to withdraw propoxyphene from the U.S. market". Food and Drug Administration. Archived from the original on 13 November 2016. Retrieved 28 November 2016.
- 1 2 Col John Lammie et al. Report of the Department Of Defense: 1,3 Dimethylamylamine (Dmaa) Safety Review Panel Archived 2014-01-19 at the Wayback Machine June 3, 2013
- ↑ FDA. "Stimulant Potentially Dangerous to Health, FDA Warns". Food and Drug Administration. Archived from the original on 1 February 2014. Retrieved 26 January 2014.
- ↑ Drotrecogin Alfa (Activated) in Adults with Septic Shock Archived 2015-09-29 at the Wayback Machine, N Engl J Med 2012; 366:2055–2064, May 31, 2012, doi:10.1056/NEJMoa1202290
- ↑ "Xigris (drotrecogin alfa (activated)) to be withdrawn due to lack of efficacy". Press release. London, UK: European Medicines Agency. 25 October 2011. Archived from the original on 28 October 2011. Retrieved 26 October 2011.
- ↑ Armstrong, Drew (25 October 2011). "Lilly Pulls Xigris Off Markets After Sepsis Drug Fails Study". Bloomberg Businessweek. Archived from the original on 2011-10-29. Retrieved 2011-10-25.
- ↑ DrugBank. "Ethyl carbamate". Archived from the original on 27 September 2013. Retrieved 24 September 2013.
- ↑ DrugBank. "Fenfluramine". Archived from the original on 27 September 2013. Retrieved 24 September 2013.
- ↑ "Withdrawal of pain medicine flupirtine endorsed". Retrieved 13 July 2018.
- ↑ FDA. "FDA approves Mylotarg for treatment of acute myeloid leukemia". Food and Drug Administration. Retrieved 17 February 2020.
- ↑ European medicines Agency. "EMA suspends Picato as a precaution while review of skin cancer risk continues" (PDF).
- ↑ "Ingenol mebutate gel (Picato▼): Increased incidence of skin tumours seen in some clinical studies".
- ↑ DrugBank. "Iproniazid". Archived from the original on 27 September 2013. Retrieved 24 September 2013.
- ↑ 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. Archived from the original on 2017-06-25.
- ↑ 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.
- ↑ 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. Archived from the original on 2015-12-24. Retrieved 2009-08-18.
- ↑ FDA (13 February 2020). "FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market". FDA. Retrieved 17 February 2020.
- ↑ Central Drugs Standard Control Organization. "Drugs Banned In India". Ministry of Health and Family Welfare, Government of India. Archived from the original on 21 February 2015. Retrieved 24 September 2013.
- ↑ "Drug Effects – Methaqualone". South African Police Service. Archived from the original on 29 August 2003. Retrieved 24 September 2013.
- ↑ Cosgrove-Mather, Bootie (December 5, 2007). "Anti-Depressant Taken Off Market". CBS NEWS. Archived from the original on 2 October 2013. Retrieved 29 September 2013.
- ↑ 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.
- ↑ Lexchin, Joel (15 March 2005). "Drug withdrawals from the Canadian market for safety reasons, 1963–2004". CMAJ. pp. 765–767. doi:10.1503/cmaj.045021. Retrieved 29 October 2023.
- ↑ DrugBank. "Oxeladin". Archived from the original on 27 September 2013. Retrieved 24 September 2013.
- ↑ DrugBank. "Oxyphenbutazone". Archived from the original on 27 September 2013. Retrieved 24 September 2013.
- ↑ Biron, P (15 May 1986). "Withdrawal of oxyphenbutazone: what about phenylbutazone?". CMAJ: Canadian Medical Association Journal. 134 (10): 1119–20. PMC 1491052. PMID 3697857.
- ↑ DrugBank. "Pemoline". Archived from the original on 27 September 2013. Retrieved 24 September 2013.
- ↑ DrugBank. "Phenacetin". Archived from the original on 27 September 2013. Retrieved 24 September 2013.
- ↑ 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.
- ↑ Commissioner, Office of the. "Safety Alerts for Human Medical Products – Phenylpropanolamine hydrochloride (PPA)". Food and Drug Administration. Archived from the original on 23 October 2016. Retrieved 28 November 2016.
- ↑ DrugBank. "Phenylpropanolamine". Archived from the original on 27 September 2013. Retrieved 24 September 2013.
- ↑ DrugBank. "Prenylamine". Archived from the original on 27 September 2013. Retrieved 24 September 2013.
- ↑ "Withdrawal of Rotavirus Vaccine Recommendation". www.cdc.gov.
- ↑ DrugBank. "Sertindole". Archived from the original on 27 September 2013. Retrieved 24 September 2013.
- ↑ "Sibutramine (brand name Reductil) Information – Australia". Abbott Laboratories. 2010. Archived from the original on 2010-10-14. Retrieved 2010-10-08.
- ↑ Health Canada Endorsed Important Safety Information on MERIDIA (Sibutramine Hydrochloride Monohydrate) Archived 2013-01-11 at the Wayback Machine: Subject: Voluntary withdrawal of Meridia (sibutramine) capsules from the Canadian market.
- ↑ "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. Archived from the original on October 7, 2011. Retrieved 2011-05-21.
- ↑ (in German) Sibutramin-Vertrieb in der Europäischen Union ausgesetzt . Abbott Laboratories in Germany. Press Release 2010-01-21. Retrieved 2010-01-27
- ↑ "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.
- ↑ "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.
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- ↑ H. Gurdon: Japan bans shingles drug after deaths Archived 2003-06-26 at the Wayback Machine BMJ 1994;309:627
- ↑ Paar, W.D; Müller-Jakic. "Ruhen der Zulassung Tetrazepam haltiger Arzneimittel in der EU (German)" (PDF). Sanofi-Aventis Deutschland GmbH. Archived from the original (PDF) on 27 September 2013. Retrieved 25 September 2013.
- ↑ Luippold, Gerd (2006). "Renaissance des Contergan-Wirkstoffs". Pharmazeutische Zeitung (German). Archived from the original on 27 September 2013. Retrieved 25 September 2013.
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- ↑ 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. S2CID 19560432.
- ↑ "SHARED CARE PROTOCOL Thioridazine" (PDF). NHS Lothian Joint Formulary. March 2012. Archived from the original (PDF) on 2015-05-18.
- ↑ DrugBank. "Triazolam". Archived from the original on 27 September 2013. Retrieved 24 September 2013.
- ↑ 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. PMC 1028185. PMID 3156214.
- ↑ Pubchem record Archived 2015-06-10 at the Wayback Machine says "withdrawn in 1983"
- ↑ DrugBank. "Zimelidine". Archived from the original on 27 September 2013. Retrieved 24 September 2013.
- ↑ 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. PMC 9003539. PMID 34058283.
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External links
- CDER Report to the Nation: 2005 Has a list of US withdrawals through 2005.