List of withdrawn drugs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Drugs or medicines may be withdrawn from commercial markets because of risks to patients, but also because of commercial reasons (e.g. lack of demand and relatively high production costs).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.
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| Drug name | Withdrawn | Country | Remarks |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| Amphetamine Mix (Adderall XR) | 2005 | Canada | Withdrawn over reports of increased risk of stroke, reinstated after increased risk not found. |
| Alatrofloxacin | 2006 | Worldwide | Serious hepatotoxicity leading to liver transplant or death. |
| Alclofenac | 1979 | UK | Vasculitis |
| Alpidem (Ananxyl) | 1995 | Worldwide | Not approved in the US, withdrawn in France in 1994 and the rest of the market in 1995 because of rare but serious hepatotoxicity. |
| Alosetron (Lotronex) | 2000 | US | Serious gastrointestinal adverse events; ischemic colitis; severe constipation. Reintroduced 2002 with restricted indication and new controls. |
| Alphaxolone/Alphadolone (Althesin) | 1984 | France, Germany, UK | Anaphylaxis, possibly due to carrier oil (Cremophor EL). |
| Amineptine (Survector) | 1999 | France, US | Hepatotoxicity, dermatological side effects, and abuse potential. |
| Aminopyrine | 1999 | France, Thailand | risk of agranulocytosis and severe acne. |
| Amobarbital | 1980 | Norway | Risk of barbiturate toxicity. |
| Amoproxan | 1970 | France | Dermatologic and ophthalmic toxicity. |
| Anagestone acetate | 1969 | Germany | Animal carcinogenicity. |
| Antrafenine | 1984 | France | Unspecific experimental toxicity. |
| Aprotinin (Trasylol) | 2008 | US | Increased risk of death. |
| Ardeparin (Normiflo) | 2001 | US | Withdrawn at request of NDA originator, "not for reason of safety or efficacy." |
| Astemizole (Hismanal) | 1999 | US, Malaysia, Multiple Nonspecified Markets | Fatal arrhythmia |
| Azaribine | 1976 | US | Thromboembolism. |
| Bendazac | 1993 | Spain | Hepatotoxicity. |
| Benoxaprofen (Oraflex, Opren) | 1982 | Germany, Spain, UK, US | Liver and kidney failure; gastrointestinal bleeding; ulcers. |
| Benzarone | 1992 | Germany | Hepatitis. |
| Benziodarone | 1964 | France, UK | Jaundice. |
| Beta-ethoxy-lacetanilanide | 1986 | Germany | Renal toxicity, animal carcinogenicity. |
| Bezitramide | 2004 | Netherlands | Risk of fatal overdose |
| Bithionol | 1967 | US | Dermatologic toxicity. |
| Brotizolam | 1989 | UK | Animal carcinogenicity. |
| Bromfenac | 1998 | US | Severe hepatitis and liver failure (requiring transplantation). |
| Bucetin | 1986 | Germany | Kidney damage |
| Buformin | 1978 | Germany | Metabolic toxicity. |
| Bunamiodyl | 1963 | Canada, UK, US | Nephropathy. |
| Butamben (Efocaine)(Butoforme) | 1964 | US | Dermatologic toxicity; psychiatric reactions. |
| Canrenone | 1986 | Germany | Animal Carcinogenicity. |
| Cerivastatin (Baycol, Lipobay) | 2001 | US | Risk of rhabdomyolysis |
| Chlormadinone (Chlormenadione) | 1970 | UK, US | Animal Carcinogenicity. |
| Chlormezanone (Trancopal) | 1996 | European Union, US, South Africa, Japan | Hepatotoxicity & Steven-Johnson Syndrome |
| Chlorphentermine | 1969 | Germany | Cardiovascular Toxicity. |
| Cianidanol | 1985 | France, Germany, Spain, Sweden | Hemolytic Anemia. |
| Cinepazide | 1988 | Spain | Agranulocytosis. |
| Cisapride (Propulsid) | 2000 | US | Risk of fatal cardiac arrhythmias |
| Clioquinol | 1973 | France, Germany, UK, US | Neurotoxicity. |
| Clobutinol | 2007 | Germany | Ventricular arrhythmia, QT-prolongation. |
| Cloforex | 1969 | Germany | Cardiovascular toxicity. |
| Clomacron | 1982 | UK | Hepatotoxicity. |
| Clometacin | 1987 | France | Hepatotoxicity. |
| Co-proxamol (Distalgesic) | 2004 | UK | Risk of overdose |
| Cyclobarbital | 1980 | Norway | Risk of overdose |
| Cyclofenil | 1987 | France | Hepatotoxicity. |
| Dantron | 1963 | Canada, UK, US | Mutagenic. withdrawn from general use in UK but permitted in terminal patients |
| Dexfenfluramine | 1997 | European Union, UK, US | Cardiotoxic |
| Propoxyphene (Darvocet/Darvon) | 2010 | Worldwide | Increased risk of heart attacks and stroke. |
| Diacetoxydiphenolisatin | 1971 | Australia | Hepatotoxicity. |
| Diethylstilbestrol | 1970s | US | Carcinogen |
| Difemerine | 1986 | Germany | Multi-Organ toxicities. |
| Dihydrostreptomycin | 1970 | US | Neuropsychiatric reaction. |
| Dilevalol | 1990 | UK | Hepatotoxicity. |
| Dimazole (Diamthazole) | 1972 | France, US | Neuropsychiatric reaction. |
| Dimethylamylamine (DMAA) | 1983 | US | Voluntarily withdrawn from market by Lily. Reintroduced as a dietary supplement in 2006; and in 2013 the FDA started work to ban it due to cardiovascular problems |
| Dinoprostone | 1990 | UK | Uterine hypotonus, fetal distress. |
| Dipyrone (Metamizole) | 1975 | UK, US, Others | Agranulocytosis, anaphylactic reactions. |
| Dithiazanine iodide | 1964 | France, US | Cardiovascular and metabolic reaction. |
| Dofetilide | 2004 | Germany | Drug interactions, prolonged QT. |
| Drotrecogin alfa (Xigris) | 2011 | Worldwide | Lack of efficacy as shown by PROWESS-SHOCK study |
| Ebrotidine | 1998 | Spain | Hepatotoxicity. |
| Efalizumab (Raptiva) | 2009 | Germany | Withdrawn because of increased risk of progressive multifocal leukoencephalopathy |
| Encainide | 1991 | UK, US | Ventricular arrhythmias. |
| Ethyl carbamate | 1963 | Canada, UK, US, | Carcinogen. |
| Etretinate | 1989 | France | Teratogen. |
| Exifone | 1989 | France | Hepatotoxicity. |
| Fen-phen (popular combination of fenfluramine and phentermine) | 1997 | Cardiotoxicity | |
| Fenclofenac | 1984 | UK | Cutaneous reactions; animal carcinogenicity. |
| Fenclozic acid | 1970 | UK, US | Hepatotoxicity. |
| Fenfluramine | 1997 | European Union, UK, US, India, South Africa, others | Cardiac valvular disease, pulmonary hypertension, cardiac fibrosis; 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. |
| Feprazone | 1984 | Germany, UK | Cutaneous reaction, multiorgan toxicity. |
| Fipexide | 1991 | France | Hepatotoxicity. |
| Flosequinan (Manoplax) | 1993 | UK, US | Increased mortality at higher doses; increased hospitalizations. |
| Flunitrazepam | 1991 | France | Abuse. |
| Flupirtine | 2018 | European Union | Liver toxicity. |
| Gatifloxacin | 2006 | US | Increased risk of dysglycemia. |
| Gemtuzumab ozogamicin (Mylotarg) | 2010 | US | No improvement in clinical benefit; risk for death. Returned to market in 2017. |
| Glafenine | 1984 | France, Germany | Anaphylaxis. |
| Grepafloxacin (Raxar) | 1999 | Withdrawn Germany, UK, US others | Cardiac repolarization; QT interval prolongation. |
| 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. |
| Indalpine | 1985 | France | Agranulocytosis. |
| Indoprofen | 1983 | Germany, Spain, UK | Animal carcinogenicity, gastrointestinal toxicity. |
| Ingenol mebutate gel | 2020 | Suspended in Europe | Increased risk of skin cancers. |
| Iodinated casein strophantin | 1964 | US | Metabolic reaction. |
| Iproniazid | 1964 | Canada | Interactions with food products containing tyrosine. |
| Isaxonine phosphate | 1984 | France | Hepatotoxicity. |
| Isoxicam | 1983 | France, Germany, Spain, others | Stevens johnson syndrome. |
| Kava Kava | 2002 | Germany | Hepatotoxicity. |
| Ketorolac | 1993 | France, Germany, others | Hemorrhage, Kidney Failure. |
| L-tryptophan | 1989 | Germany, UK | Eosinophilic myalgia syndrome. 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. |
| Levomethadyl acetate | 2003 | US | Cardiac arrhythmias and cardiac arrest. |
| Lorcaserin (Belviq) | 2020 | US | Increased risk of cancer. |
| 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. |
| Methandrostenolone | 1982 | France, Germany, UK, US, others | Off-label abuse. |
| Methapyrilene | 1979 | Germany, UK, US | Animal carcinogenicity. |
| Methaqualone | 1984 | South Africa (1971), India (1984), United Nations (1971–1988) | Withdrawn because of risk of addiction and overdose |
| Metipranolol | 1990 | UK, others | Uveitis. |
| Metofoline | 1965 | US | Unspecific experimental toxicity. |
| Mibefradil | 1998 | European Union, Malaysia, US, others | Fatal arrhythmia, drug interactions. |
| Minaprine | 1996 | France | Convulsions. |
| Moxisylyte | 1993 | France | Necrotic hepatitis. |
| Muzolimine | 1987 | France, Germany, European Union | Polyneuropathy. |
| Natalizumab (Tysabri) | 2005–2006 | US | Voluntarily withdrawn from US market because of risk of Progressive multifocal leukoencephalopathy (PML). Returned to market July, 2006. |
| Nialamide | 1974 | UK, US | Hepatotoxicity, drug intereaction. |
| Nikethamide | 1988 | multiple markets | CNS Stimulation. |
| Nitrefazole | 1984 | Germany | Hepatic and hematologic toxicity. |
| Nomifensine | 1981–1986 | France, Germany, Spain, UK, US, others | Hemolytic Anemia, hepatotoxicity, serious hypersensitive reactions. |
| Oxeladin | 1976 | Canada, UK, US (1976) | Carcinogen. |
| Oxyphenbutazone | 1984–1985 | UK, US, Germany, France, Canada | Bone marrow suppression, Stevens–Johnson syndrome. |
| Oxyphenisatin (Phenisatin) | 1970s | Australia, France, Germany, UK, US | Hepatotoxicity. |
| Ozogamicin | 2010 | US | No improvement in clinical benefit; risk for death; veno-occlusive disease. |
| Pemoline (Cylert) | 1997 | Canada, UK | Withdrawn from US in 2005 due to hepatotoxicity. |
| Pentobarbital | 1980 | Norway | Risk of fatal overdose. |
| Pentylenetetrazol | 1982 | US | Withdrawn for inability to produce effective convulsive therapy, and for causing seizures. |
| Pergolide (Permax) | 2007 | US | Risk for heart valve damage. |
| Perhexiline | 1985 | UK, Spain | Neurologic and hepatic toxicity. |
| Phenacetin | 1975 | Canada | An ingredient in "A.P.C." tablet; withdrawn because of risk of cancer and kidney disease Germany Denmark, UK, US, others Reason: nephropathy. |
| Phenformin and Buformin | 1977 | France, Germany US | Severe lactic acidosis |
| Phenolphthalein | 1997 | US | Possible carcinogen. |
| Phenoxypropazine | 1966 | UK | Hepatotoxicity, drug intereaction. |
| Phenylbutazone | 1985 | Germany | Off-label abuse, hematologic toxicity. |
| Phenylpropanolamine (Propagest, Dexatrim) | 2000 | Canada, US | Hemorrhagic stroke. |
| Pifoxime (=Pixifenide) | 1976 | France | Neuropsychiatric reaction. |
| Pirprofen | 1990 | France, Germany, Spain | Liver toxicity. |
| Prenylamine | 1988 | Canada, France, Germany, UK, US, others | Cardiac arrythmia and death. |
| Proglumide | 1989 | Germany | Respiratory reaction. |
| Pronethalol | 1965 | UK | Animal carcinogenicity. |
| Propanidid | 1983 | UK | Allergy. |
| Proxibarbal | 1998 | Spain, France, Italy, Portugal, Turkey | Immunoallergic, thrombocytopenia. |
| Pyrovalerone | 1979 | France | Abuse. |
| 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. |
| Remoxipride | 1993 | UK, others | Aplastic anemia. |
| rhesus rotavirus vaccine-tetravalent (RotaShield) | 1999 | US | Withdrawn due to risk of intussusception. |
| Rimonabant (Acomplia) | 2008 | Worldwide | Risk of severe depression and suicide. |
| Rofecoxib (Vioxx) | 2004 | Worldwide | Withdrawn by Merck & Co. Risk of myocardial infarction and stroke. |
| 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 | |
| Sertindole | 1998 | European Union | Arrhythmia and sudden cardiac death |
| Sibutramine (Reductil/Meridia) | 2010 | Australia, Canada, China, the European Union (EU), Hong Kong, India, Mexico, New Zealand, the Philippines, Thailand, the United Kingdom, and the United States | Increased risk of heart attack and stroke. |
| Sitaxentan | 2010 | Germany | Hepatotoxicity. |
| Sorivudine | 1993 | Japan | Drug interaction and deaths. |
| Sparfloxacin | 2001 | US | QT prolongation and phototoxicity. |
| Sulfacarbamide | 1988 | Germany | Dermatologic, hematologic and hepatic reactions. |
| Sulfamethoxydiazine | 1988 | Germany | Unknown. |
| Sulfamethoxypyridazine | 1986 | UK | Dermatologic and hematologic reactions. |
| Suloctidil | 1985 | Germany, France, Spain | Hepatotoxicity. |
| Suprofen | 1986–1987 | UK, Spain, US | Kidney damage. |
| Tegaserod (Zelnorm) | 2007 | US | Risk for heart attack, stroke, and unstable angina. 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 |
| 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 |
| Terodiline (Micturin) | 1991 | Germany, UK, Spain, others | Prolonged QT interval, ventricular tachycardia and arrhythmia. |
| Tetrazepam | 2013 | European Union | Serious cutaneous reactions. |
| Thalidomide | 1961 | Germany | Withdrawn because of risk of teratogenicity; returned to market for use in leprosy and multiple myeloma under FDA orphan drug rules |
| Thenalidine | 1963 | Canada, UK, US | Neutropenia |
| Thiobutabarbitone | 1993 | Germany | Kidney injury. |
| Thioridazine (Melleril) | 2005 | Germany, UK | Withdrawn worldwide due to severe cardiac arrhythmias Continues to be available in Russia. |
| Ticrynafen (Tienilic acid) | 1980 | Germany, France, UK, US others | Liver toxicity and death. |
| Tolcapone (Tasmar) | 1998 | European Union, Canada, Australia | Hepatotoxicity |
| Tolrestat (Alredase) | 1996 | Argentina, Canada, Italy, others | Severe hepatotoxicity |
| Triacetyldiphenolisatin | 1971 | Australia | Hepatotoxicity. |
| Triazolam | 1991 | France, Netherlands, Finland, Argentina, UK others | Psychiatric adverse drug reactions, amnesia. |
| Triparanol | 1962 | France, US | Cataracts, alopecia, ichthyosis. |
| Troglitazone (Rezulin) | 2000 | US, Germany | Hepatotoxicity |
| Trovafloxacin (Trovan) | 1999–2001 | European Union, US | Withdrawn because of risk of liver failure |
| Valdecoxib (Bextra) | 2004 | US | Risk of heart attack and stroke. |
| Vincamine | 1987 | Germany | Hematologic toxicity. |
| Xenazoic acid | 1965 | France | Hepatotoxicity. |
| Ximelagatran (Exanta) | 2006 | Germany | Hepatotoxicity |
| Zimelidine | 1983 | Worldwide | Risk of Guillain–Barré syndrome, hypersensitivity reaction, hepatotoxicity banned worldwide. |
| Zomepirac | 1983 | UK, Germany, Spain, US | Anaphylactic reactions and non-fatal allergic reactions, kidney failure |
Withdrawn clinical trial drugs
- RG7795, in 2021 discontinued development
See also
External links
- CDER Report to the Nation: 2005 Has a list of US withdrawals through 2005.