List of withdrawn drugs
Significant withdrawals

List of withdrawn drugs

Section Title: Significant withdrawals
Table Section Text: None

Drug name	Withdrawn	Country	Remarks

Adderall XR	2005	Canada	Risk of stroke 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.

Alclofenac	1979	UK	Vasculitis, Rash.

Alpidem (Ananxyl)	1995	Worldwide	Not approved in the US, withdrawn in France in 1994 and the rest of the market in 1995 because of rare but serious hepatotoxicity.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 on a restricted basis

Althesin (=Alphaxolone amineptine + Alphadolone)	1984	France, Germany, UK	Anaphylaxis.

Amineptine (Survector)	1999	France, US	Hepatotoxicity, dermatological side effects, and abuse potential. Reason:

Aminopyrine	1999	France, Thailand	risk of agranulocytosis; severe acne.

Amobarbital	1980	Norway	Risk of overdose.

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	Not for reasons of safety or efficacy.

Astemizole (Hismanal)	1999	US, Malaysia, Multiple Nonspecified Markets	Fatal arrhythmia

Azaribine	1976	US	Thromboembolism.

Bendazac	1993	Spain	Hepatotoxicity.

Benoxaprofen	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.

Broazolam	1989	UK	Animal carcinogenicity.

Bromfenac	1998	US	Severe hepatitis and liver failure (some 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,	Carcinogenicity.

Etretinate	1989	France	Withdrawn US (1999). Risk for birth defects.

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.

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.

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.

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, renal 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.

Levomethadyl acetate	2003	US	Cardiac arrhythmias and cardiac arrest.

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.

Nefazodone	2007	US, Canada, others	Branded version withdrawn by originator in several countries in 2007 for hepatotoxicity. Generic versions available.

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)	Carcinogenicity.

Oxyphenbutazone	1984–1985	UK, US, Germany, France, Canada	Bone marrow suppression, Stevens–Johnson syndrome.

Oxyphenisatin (Phenisatin)	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. Hepatotoxicity Reason: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	Carcinogenicity.

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.

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.

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	Renal insufficiency.

Thioridazine (Melleril)	2005	Germany, UK	Withdrawn worldwide due to severe cardiac arrhythmias

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, renal failure

Sentence(s)

In 1995, Alpidem was withdrawn from the market in most of the world following reports of severe liver damage.

final_sentence: In 1995, Alpidem was withdrawn from the market in most of the world following reports of severe liver damage.