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List of withdrawn drugs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Drugs or medicines may be withdrawn from commercial markets because of risks to patients, but also because of commercial reasons (e.g. lack of demand and relatively high production costs).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| Drug name | Withdrawn | Country | Remarks |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| Amphetamine Mix (Adderall XR) | 2005 | Canada | Withdrawn over reports of increased risk of stroke, reinstated after increased risk not found.[1] |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| Alpidem (Ananxyl) | 1995 | Worldwide | Not approved in the US, withdrawn in France in 1994[4] and the rest of the market in 1995 because of rare but serious hepatotoxicity.[3][5] |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
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