List of withdrawn drugs
Encyclopedia
Some drugs
have been withdrawn from the market because of risks to the patients. Usually this has been prompted by unexpected adverse effects that were not detected during Phase III clinical trials and were only apparent from postmarketing surveillance
data from the wider patient community.
This list is not limited to drugs that were ever approved by the FDA. Some of them (Lumiracoxib, Rimonabant, Tolrestat, Ximelagatran and Zimelidine, for example) were approved to be marketed in Europe but had not yet been approved for marketing in the U.S., when side effects became clear and their developers pulled them from the market. Likewise LSD was never approved for marketing in the U.S.
Medication
A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease.- Classification :...
have been withdrawn from the market because of risks to the patients. Usually this has been prompted by unexpected adverse effects that were not detected during Phase III clinical trials and were only apparent from postmarketing surveillance
Postmarketing surveillance
Postmarketing surveillance is the practice of monitoring the safety of a pharmaceutical drug or device after it has been released on the market and is an important part of the science of pharmacovigilance...
data from the wider patient community.
This list is not limited to drugs that were ever approved by the FDA. Some of them (Lumiracoxib, Rimonabant, Tolrestat, Ximelagatran and Zimelidine, for example) were approved to be marketed in Europe but had not yet been approved for marketing in the U.S., when side effects became clear and their developers pulled them from the market. Likewise LSD was never approved for marketing in the U.S.
Significant withdrawals
| Drug name | Withdrawn | Remarks |
|---|---|---|
| Thalidomide Thalidomide Thalidomide was introduced as a sedative drug in the late 1950s that was typically used to cure morning sickness. In 1961, it was withdrawn due to teratogenicity and neuropathy. There is now a growing clinical interest in thalidomide, and it is introduced as an immunomodulatory agent used... |
1950s–1960s | Withdrawn because of risk of teratogenicity; returned to market for use in leprosy Leprosy Leprosy or Hansen's disease is a chronic disease caused by the bacteria Mycobacterium leprae and Mycobacterium lepromatosis. Named after physician Gerhard Armauer Hansen, leprosy is primarily a granulomatous disease of the peripheral nerves and mucosa of the upper respiratory tract; skin lesions... and multiple myeloma Multiple myeloma Multiple myeloma , also known as plasma cell myeloma or Kahler's disease , is a cancer of plasma cells, a type of white blood cell normally responsible for the production of antibodies... under FDA orphan drug Orphan drug An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease... rules |
| Lysergic acid diethylamide (LSD) | 1950s–1960s | Marketed as a psychiatric drug; withdrawn after it became widely used recreationally |
| Diethylstilbestrol Diethylstilbestrol Diethylstilbestrol is a synthetic nonsteroidal estrogen that was first synthesized in 1938. Human exposure to DES occurred through diverse sources, such as dietary ingestion from supplemented cattle feed and medical treatment for certain conditions, including breast and prostate cancers... |
1970s | Withdrawn because of risk of teratogenicity |
| Phenformin Phenformin Phenformin is an anti-diabetic drug from the biguanide class. It was marketed as DBI by Ciba-Geigy but was withdrawn from most markets in the late 1970s due to a high risk of lactic acidosis, which was fatal in 50% of cases.... and Buformin Buformin Buformin is an oral anti-diabetic drug of the biguanide class, chemically related to metformin and phenformin. Buformin was marketed by German pharmaceutical company Grünenthal as Silubin.-Chemistry and Animal Toxicology:... |
1978 | Withdrawn because of risk of lactic acidosis Lactic acidosis Lactic acidosis is a physiological condition characterized by low pH in body tissues and blood accompanied by the buildup of lactate especially D-lactate, and is considered a distinct form of metabolic acidosis. The condition typically occurs when cells receive too little oxygen , for example... |
| Ticrynafen Ticrynafen Tienilic acid or ticrynafen is a diuretic drug with uric acid-lowering action, formerly marketed for the treatment of hypertension... |
1982 | Withdrawn because of risk of hepatitis Hepatitis Hepatitis is a medical condition defined by the inflammation of the liver and characterized by the presence of inflammatory cells in the tissue of the organ. The name is from the Greek hepar , the root being hepat- , meaning liver, and suffix -itis, meaning "inflammation"... |
| Zimelidine Zimelidine Zimelidine was the first selective serotonin reuptake inhibitor antidepressant to be marketed. It is a pyridylallylamine, and is structurally different from other antidepressants.... |
1983 | Withdrawn worldwide because of risk of Guillain-Barré syndrome Guillain-Barré syndrome Guillain–Barré syndrome , sometimes called Landry's paralysis, is an acute inflammatory demyelinating polyneuropathy , a disorder affecting the peripheral nervous system. Ascending paralysis, weakness beginning in the feet and hands and migrating towards the trunk, is the most typical symptom... |
| Phenacetin Phenacetin Phenacetin is an analgesic, once widely used; its use has declined because of its adverse effects.-History:Phenacetin was introduced in 1887, and was used principally as an analgesic, and was one of the first synthetic fever reducers to go on the market... |
1983 | An ingredient in "A.P.C." tablet; withdrawn because of risk of cancer and kidney disease |
| Methaqualone Methaqualone Methaqualone is a sedative-hypnotic drug that is similar in effect to barbiturates, a general central nervous system depressant. The sedative-hypnotic activity was first noted by Indian researchers in the 1950s and in 1962 methaqualone itself was patented in the US by Wallace and Tiernan... |
1984 | Withdrawn because of risk of addiction Substance dependence The section about substance dependence in the Diagnostic and Statistical Manual of Mental Disorders does not use the word addiction at all. It explains:... and overdose |
| Nomifensine Nomifensine Nomifensine is a norepinephrine-dopamine reuptake inhibitor developed by a team at Hoechst AG in the 1960s.. The drug was test-marketed in the United States by Hoechst AG , i.e. a drug that increases the amount of synaptic norepinephrine and dopamine available to receptors by blocking the dopamine... (Merital) |
1986 | Withdrawn because of risk of hemolytic anemia |
| Triazolam Triazolam Triazolam is a benzodiazepine drug. It possesses pharmacological properties similar to that of other benzodiazepines, but it is generally only used as a sedative to treat severe insomnia... |
1991 | Withdrawn in the United Kingdom United Kingdom The United Kingdom of Great Britain and Northern IrelandIn the United Kingdom and Dependencies, other languages have been officially recognised as legitimate autochthonous languages under the European Charter for Regional or Minority Languages... because of risk of psychiatric adverse drug reaction Adverse drug reaction An adverse drug reaction is an expression that describes harm associated with the use of given medications at a normal dosage. ADRs may occur following a single dose or prolonged administration of a drug or result from the combination of two or more drugs... s. This drug continues to be available in the U.S. |
| Terodiline Terodiline Terodiline is a drug used in urology as an antispasmodic.... (Micturin) |
1991 | Prolonged QT interval |
| Temafloxacin Temafloxacin Temafloxacin , is a fluoroquinolone antibiotic drug which was withdrawn from sale in the United States shortly after its approval in 1992 because of serious adverse effects resulting in three deaths.... |
1992 | Withdrawn in the United States because of allergic reactions and cases of hemolytic anemia Hemolytic anemia Hemolytic anemia is a form of anemia due to hemolysis, the abnormal breakdown of red blood cells , either in the blood vessels or elsewhere in the human body . It has numerous possible causes, ranging from relatively harmless to life-threatening... , leading to three patient deaths.http://www.fda.gov/bbs/topics/NEWS/NEW00279.html |
| Flosequinan Flosequinan Flosequinan is a quinolone vasodilator. It has direct relaxing effects on peripheral arteries and veins. It is administered orally in cases of congestive heart failure in patients who are not responsive to digitalis or ACE inhibitors. It was sold under the trade name Manoplax.It was withdrawn... (Manoplax) |
1993 | Withdrawn in the United States because of an increased risk of hospitalization or death |
| Alpidem Alpidem Alpidem is an anxiolytic drug from the imidazopyridine family, related to the more well known sleeping medication zolpidem. Unlike zolpidem however, alpidem does not produce sedative effects at normal doses, and is instead used specifically for the treatment of anxiety.Alipidem was developed by ... (Ananxyl) |
1996 | Withdrawn because of rare but serious hepatotoxicity Hepatotoxicity Hepatotoxicity implies chemical-driven liver damage.The liver plays a central role in transforming and clearing chemicals and is susceptible to the toxicity from these agents. Certain medicinal agents, when taken in overdoses and sometimes even when introduced within therapeutic ranges, may injure... . |
| Chlormezanone Chlormezanone Chlormezanone is a drug used as an anxiolytic and a muscle relaxant.Its use was discontinued in many countries in 1996, due to rare but serious cases of toxic epidermal necrolysis.- Chemistry :... (Trancopal) |
1996 | Withdrawn because of rare but serious cases of toxic epidermal necrolysis Toxic epidermal necrolysis Toxic epidermal necrolysis is a rare, life-threatening dermatological condition that is usually induced by a reaction to medications... |
| Fen-phen Fen-phen The drug combination fenfluramine/phentermine, usually called fen-phen, is an anti-obesity treatment that utilizes two anorectics. Fenfluramine, its S-enantiomer dexfenfluramine, and a few other serotonin agonists were shown to cause potentially fatal pulmonary hypertension and heart valve... (popular combination of fenfluramine Fenfluramine Fenfluramine is a drug that was part of the Fen-Phen anti-obesity medication . Fenfluramine was introduced on the U.S. market in 1973. It is the racemic mixture of two enantiomers, dextrofenfluramine and levofenfluramine... and phentermine Phentermine Phentermine, a contraction of "phenyl-tertiary-butylamine", is a psychostimulant drug of the phenethylamine class, chemically related to amphetamine. It is used medically as an appetite suppressant.... ) |
1997 | Phentermine remains on the market, dexfenfluramine Dexfenfluramine Dexfenfluramine, marketed as dexfenfluramine hydrochloride under the name Redux, is a serotoninergic anorectic drug: it reduces appetite by increasing the amount of extracellular serotonin in the brain... and fenfluramine – later withdrawn as caused heart valve Heart valve A heart valve normally allows blood flow in only one direction through the heart. The four valves commonly represented in a mammalian heart determine the pathway of blood flow through the heart... disorder |
| Tolrestat Tolrestat Tolrestat is an aldose reductase inhibitor which was approved for the control of certain diabetic complications.While it was approved for marketed in several countries, it failed a Phase III trial in the U.S. due to toxicity and never received FDA approval. It was discontinued by Wyeth in 1997... (Alredase) |
1997 | Withdrawn because of risk of severe hepatotoxicity Hepatotoxicity Hepatotoxicity implies chemical-driven liver damage.The liver plays a central role in transforming and clearing chemicals and is susceptible to the toxicity from these agents. Certain medicinal agents, when taken in overdoses and sometimes even when introduced within therapeutic ranges, may injure... |
| Terfenadine Terfenadine Terfenadine is an antihistamine formerly used for the treatment of allergic conditions. It was brought to market by Hoechst Marion Roussel and marketed under various brand names including Seldane in the United States, Triludan in the United Kingdom, and Teldane in Australia... (Seldane, Triludan) |
1998 | Withdrawn because of risk of cardiac arrhythmias; superseded by fexofenadine Fexofenadine Fexofenadine is an antihistamine drug used in the treatment of hayfever and similar allergy symptoms... |
| Mibefradil Mibefradil Mibefradil is a drug for the treatment of hypertension and chronic angina pectoris. It belongs to a group known as calcium channel blockers.It is nonselective.... (Posicor) |
1998 | Withdrawn because of dangerous interactions with other drugs |
| Etretinate Etretinate Etretinate is a medication developed by Hoffmann–La Roche that was approved by the FDA in 1986 to treat severe psoriasis... |
1990s | Risk of birth defects; narrow therapeutic index |
| Tolcapone Tolcapone Tolcapone is a drug that inhibits the enzyme catechol-O-methyl transferase . - Uses :Tolcapone is used in the treatment of Parkinson's disease as an adjunct to levodopa/carbidopa medication.- Chemistry :... (Tasmar) |
1998 | Hepatotoxicity |
| Temazepam Temazepam Temazepam is an intermediate-acting 3-hydroxy benzodiazepine. It is mostly prescribed for the short-term treatment of sleeplessness in patients who have difficulty maintaining sleep... (Restoril, Euhypnos, Normison, Remestan, Tenox, Norkotral) |
1999 | Withdrawn in Sweden Sweden Sweden , officially the Kingdom of Sweden , is a Nordic country on the Scandinavian Peninsula in Northern Europe. Sweden borders with Norway and Finland and is connected to Denmark by a bridge-tunnel across the Öresund.... and Norway Norway Norway , officially the Kingdom of Norway, is a Nordic unitary constitutional monarchy whose territory comprises the western portion of the Scandinavian Peninsula, Jan Mayen, and the Arctic archipelago of Svalbard and Bouvet Island. Norway has a total area of and a population of about 4.9 million... because of 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 U.S., but under strict controls. |
| Astemizole Astemizole Astemizole was a second generation antihistamine drug which has a long duration of action. Astemizole was discovered by Janssen Pharmaceutica in 1977... (Hismanal) |
1999 | Arrhythmias because of interactions with other drugs |
| Grepafloxacin Grepafloxacin Grepafloxacin hydrochloride was a oral broad-spectrum quinoline antibacterial agent used to treat bacterial infections... (Raxar) |
1999 | Prolonged QT interval |
| Levamisole Levamisole Levamisole is an anthelminthic and immunomodulator belonging to a class of synthetic imidazothiazole derivatives. It was discovered at Janssen Pharmaceutica in 1966... (Ergamisol) |
1999 | Still used as veterinary drug; in humans was used to treat melanoma before it was withdrawn for agranulocytosis Agranulocytosis Granulopenia, also known as Agranulosis or Agranulocytosis, is an acute condition involving a severe and dangerous leukopenia , most commonly of neutrophils causing a neutropenia in the circulating blood. It represents a severe lack of one major class of infection-fighting white blood cells... |
| Troglitazone Troglitazone Troglitazone is an anti-diabetic and antiinflammatory drug, and a member of the drug class of the thiazolidinediones. It was developed by Daiichi Sankyo Co.. In the United States, it was introduced and manufactured by Parke-Davis in the late 1990s, but turned out to be associated with an... (Rezulin) |
2000 | Withdrawn because of risk of hepatotoxicity Hepatotoxicity Hepatotoxicity implies chemical-driven liver damage.The liver plays a central role in transforming and clearing chemicals and is susceptible to the toxicity from these agents. Certain medicinal agents, when taken in overdoses and sometimes even when introduced within therapeutic ranges, may injure... ; superseded by pioglitazone Pioglitazone Pioglitazone is a prescription drug of the class thiazolidinedione with hypoglycemic action.Pioglitazone is marketed as trademarks Actos in the USA, Canada, the UK and Germany, Glustin in Europe,"Glizone" and "Pioz" in India by Zydus CND and USV respectively and Zactos in Mexico by Takeda... and rosiglitazone Rosiglitazone Rosiglitazone is an antidiabetic drug in the thiazolidinedione class of drugs. It works as an insulin sensitizer, by binding to the PPAR receptors in fat cells and making the cells more responsive to insulin... |
| Alosetron Alosetron Alosetron is a 5-HT3 antagonist used for the management of severe diarrhea-predominant irritable bowel syndrome in women only. It is currently marketed by Prometheus Laboratories Inc... (Lotronex) |
2000 | Withdrawn because of risk of fatal complications of constipation Constipation Constipation refers to bowel movements that are infrequent or hard to pass. Constipation is a common cause of painful defecation... ; reintroduced 2002 on a restricted basis |
| Cisapride Cisapride Cisapride is a gastroprokinetic agent, a drug which increases motility in the upper gastrointestinal tract. It acts directly as a serotonin 5-HT4 receptor agonist and indirectly as a parasympathomimetic. Stimulation of the serotonin receptors increases acetylcholine release in the enteric nervous... (Propulsid) |
2000s | Withdrawn in many countries because of risk of cardiac arrhythmias |
| Amineptine Amineptine Amineptine was developed by the French Society of Medical research in the 1960s. Under the trade-names is used as an atypical tricyclic antidepressant that selectively inhibits the reuptake of dopamine and to a lesser extent norepinephrine, thus exerting a powerful and fast-acting... (Survector) |
2000 | Withdrawn because of hepatotoxicity Hepatotoxicity Hepatotoxicity implies chemical-driven liver damage.The liver plays a central role in transforming and clearing chemicals and is susceptible to the toxicity from these agents. Certain medicinal agents, when taken in overdoses and sometimes even when introduced within therapeutic ranges, may injure... , dermatological side effects, and abuse Drug abuse Substance abuse, also known as drug abuse, refers to a maladaptive pattern of use of a substance that is not considered dependent. The term "drug abuse" does not exclude dependency, but is otherwise used in a similar manner in nonmedical contexts... potential. |
| Phenylpropanolamine Phenylpropanolamine Phenylpropanolamine , also known as the stereoisomers norephedrine and norpseudoephedrine, is a psychoactive drug of the phenethylamine and amphetamine chemical classes which is used as a stimulant, decongestant, and anorectic agent. It is commonly used in prescription and over-the-counter cough... (Propagest, Dexatrim Dexatrim Dexatrim is an over-the-counter dietary supplement meant to assist with weight loss. Dexatrim claims it “gives you the power to lose weight, curb binges, and keep you in control of your diet.” Current Dexatrim products available are in capsule form and include Dexatrim Max Complex 7, Dexatrim Max... ) |
2000 | Withdrawn because of risk of stroke Stroke A stroke, previously known medically as a cerebrovascular accident , is the rapidly developing loss of brain function due to disturbance in the blood supply to the brain. This can be due to ischemia caused by blockage , or a hemorrhage... in women under 50 years of age when taken at high doses (75 mg twice daily) for weight loss. |
| Trovafloxacin Trovafloxacin Trovafloxacin is a broad spectrum antibiotic that inhibits the uncoiling of supercoiled DNA in various bacteria by blocking the activity of DNA gyrase and topoisomerase IV. It was withdrawn from the market due to the risk of hepatotoxicity... (Trovan) |
2001 | Withdrawn because of risk of liver failure Liver failure Acute liver failure is the appearance of severe complications rapidly after the first signs of liver disease , and indicates that the liver has sustained severe damage . The complications are hepatic encephalopathy and impaired protein synthesis... |
| Cerivastatin Cerivastatin Cerivastatin is a synthetic member of the class of statins used to lower cholesterol and prevent cardiovascular disease. It was marketed by the pharmaceutical company Bayer A.G. in the late 1990s, competing with Pfizer's highly successful atorvastatin... (Baycol, Lipobay) |
2001 | Withdrawn because of risk of rhabdomyolysis Rhabdomyolysis Rhabdomyolysis is a condition in which damaged skeletal muscle tissue breaks down rapidly. Breakdown products of damaged muscle cells are released into the bloodstream; some of these, such as the protein myoglobin, are harmful to the kidneys and may lead to kidney failure... |
| Rapacuronium Rapacuronium Rapacuronium is a rapidly acting, non-depolarizing neuromuscular blocker formerly used in modern anaesthesia, to aid and enable endotracheal intubation, which is often necessary to assist in the controlled ventilation of unconscious patients during surgery and sometimes in intensive care... (Raplon) |
2001 | Withdrawn in many countries because of risk of fatal bronchospasm Bronchospasm Bronchospasm or a bronchial spasm is a sudden constriction of the muscles in the walls of the bronchioles. It is caused by the release of substances from mast cells or basophils under the influence of anaphylatoxins... |
| Rofecoxib Rofecoxib Rofecoxib is a nonsteroidal anti-inflammatory drug that has now been withdrawn over safety concerns. It was marketed by Merck & Co. to treat osteoarthritis, acute pain conditions, and dysmenorrhoea... (Vioxx) |
2004 | Withdrawn because of risk of myocardial infarction Myocardial infarction Myocardial infarction or acute myocardial infarction , commonly known as a heart attack, results from the interruption of blood supply to a part of the heart, causing heart cells to die... |
| Co-proxamol (Distalgesic) | 2004 | Withdrawn in the UK due to overdose dangers. |
| mixed amphetamine salts (Adderall XR) Adderall Adderall is a brand name of amphetamine salts–based medication used for attention-deficit hyperactivity disorder and narcolepsy. It is a brand-name psychostimulant medication composed of racemic amphetamine aspartate monohydrate, racemic amphetamine sulfate, dextroamphetamine saccharide, and... |
2005 | Withdrawn in Canada Canada Canada is a North American country consisting of ten provinces and three territories. Located in the northern part of the continent, it extends from the Atlantic Ocean in the east to the Pacific Ocean in the west, and northward into the Arctic Ocean... because of risk of stroke Stroke A stroke, previously known medically as a cerebrovascular accident , is the rapidly developing loss of brain function due to disturbance in the blood supply to the brain. This can be due to ischemia caused by blockage , or a hemorrhage... . See Health Canada press release. 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. |
| hydromorphone extended-release (Palladone) Hydromorphone Hydromorphone, a more common synonym for dihydromorphinone, commonly a hydrochloride is a very potent centrally-acting analgesic drug of the opioid class. It is a derivative of morphine, to be specific, a hydrogenated ketone thereof and, therefore, a semi-synthetic drug... |
2005 | Withdrawn because of a high risk of accidental overdose when administered with alcohol |
| Thioridazine Thioridazine Thioridazine is a piperidine typical antipsychotic drug belonging to the phenothiazine drug group and was previously widely used in the treatment of schizophrenia and psychosis... (Melleril) |
2005 | Withdrawn from U.K. market because of cardiotoxicity |
| Pemoline Pemoline Pemoline was first synthesized in 1913 but it's activity was not discovered until the 1930s. Under the names it was used as a medication used to treat attention-deficit hyperactivity disorder and narcolepsy. Under the Convention on Psychotropic Substances, it is a Schedule IV drug... (Cylert) |
2005 | Withdrawn from U.S. market because of hepatotoxicity |
| Natalizumab Natalizumab Natalizumab is a humanized monoclonal antibody against the cellular adhesion molecule α4-integrin. Natalizumab is used in the treatment of multiple sclerosis and Crohn's disease. It is co-marketed by Biogen Idec and Élan as Tysabri, and was previously named Antegren. Natalizumab is administered by... (Tysabri) |
2005–2006 | Voluntarily withdrawn from U.S. market because of risk of Progressive multifocal leukoencephalopathy Progressive multifocal leukoencephalopathy Progressive multifocal leukoencephalopathy , also known as progressive multifocal leukoencephalitis, is a rare and usually fatal viral disease that is characterized by progressive damage or inflammation of the white matter of the brain at multiple locations .It occurs almost exclusively in... (PML). Returned to market July, 2006. |
| Ximelagatran Ximelagatran Ximelagatran is an anticoagulant that has been investigated extensively as a replacement for warfarin that would overcome the problematic dietary, drug interaction, and monitoring issues associated with warfarin therapy... (Exanta) |
2006 | Withdrawn because of risk of hepatotoxicity Hepatotoxicity Hepatotoxicity implies chemical-driven liver damage.The liver plays a central role in transforming and clearing chemicals and is susceptible to the toxicity from these agents. Certain medicinal agents, when taken in overdoses and sometimes even when introduced within therapeutic ranges, may injure... (liver damage). |
| Pergolide Pergolide Pergolide is an ergoline-based dopamine receptor agonist used in some countries for the treatment of Parkinson's disease.... (Permax) |
2007 | Voluntarily withdrawn in the U.S. because of the risk of heart valve Heart valve A heart valve normally allows blood flow in only one direction through the heart. The four valves commonly represented in a mammalian heart determine the pathway of blood flow through the heart... damage. Still available elsewhere. |
| Tegaserod Tegaserod Tegaserod is a 5-HT4 agonist manufactured by Novartis and sold under the name Zelnorm for the management of irritable bowel syndrome and constipation. Approved by the FDA in 2002, it was subsequently removed from the market in 2007 due to FDA concerns about possible adverse cardiovascular effects... (Zelnorm) |
2007 | Withdrawn because of imbalance of cardiovascular ischemic events, including heart attack and stroke. Was available through a restricted access program until April 2008. |
| Aprotinin Aprotinin The drug aprotinin , is the bovine version of the small protein basic pancreatic trypsin inhibitor, or BPTI, which inhibits trypsin and related proteolytic enzymes. Under the trade name Trasylol, aprotinin was used as a medication administered by injection to reduce bleeding during complex surgery,... (Trasylol) |
2007 | Withdrawn because of increased risk of complications or death; permanently withdrawn in 2008 except for research use |
| Inhaled insulin (Exubera) | 2007 | Withdrawn in the UK due to poor sales caused by national restrictions on prescribing, doubts over long term safety and too high a cost |
| Lumiracoxib Lumiracoxib Lumiracoxib is a COX-2 selective inhibitor non-steroidal anti-inflammatory drug, manufactured by Novartis and still sold in few countries, including Mexico, Ecuador and the Dominican Republic, under the trade name Prexige .Lumiracoxib has several distinctive features... (Prexige) |
2007–2008 | Progressively withdrawn around the world because of serious side effects, mainly liver damage |
| Rimonabant Rimonabant Rimonabant is an anorectic antiobesity drug that has been withdrawn from the market. It is an inverse agonist for the cannabinoid receptor CB1... (Acomplia) |
2008 | Withdrawn around the world because of risk of severe depression and suicide |
| Efalizumab Efalizumab Efalizumab is a formerly available medication designed to treat autoimmune diseases, origianally marketed to treat psoriasis. As implied by the suffix -zumab, it is a recombinant humanized monoclonal antibody administered once weekly by subcutaneous injection... (Raptiva) |
2009 | Withdrawn because of increased risk of progressive multifocal leukoencephalopathy; to be completely withdrawn from market by June 2009 |
| Sibutramine Sibutramine Sibutramine is an oral anorexiant. Until 2010 it was marketed and prescribed as an adjunct in the treatment of exogenous obesity along with diet and exercise... (Reductil/Meridia) |
2010 | Withdrawn in Europe, Australasia, Canada, and the U.S. because of increased cardiovascular risk |
| Gemtuzumab ozogamicin Gemtuzumab ozogamicin Gemtuzumab ozogamicin is a drug-linked monoclonal antibody that was used to treat acute myelogenous leukemia from 2000-2010... (Mylotarg) |
2010 | Withdrawn in the U.S. due to increased risks of veno-occlusive disease and based on results of a clinical trial in which it showed no benefit in acute myeloid leukemia (AML) |
| Rosiglitazone Rosiglitazone Rosiglitazone is an antidiabetic drug in the thiazolidinedione class of drugs. It works as an insulin sensitizer, by binding to the PPAR receptors in fat cells and making the cells more responsive to insulin... (Avandia) |
2010 | Withdrawn in Europe because of increased risk of heart attacks and death. This drug continues to be available in the U.S. |
| Drotrecogin alfa Drotrecogin alfa Drotrecogin alfa is a recombinant form of human activated protein C that has anti-thrombotic, anti-inflammatory, and profibrinolytic properties. Drotrecogin alpha belongs to the class of serine proteases. Drotrecogin alfa has not been found to improve outcomes in people with severe sepsis... (Xigris) |
2011 | Withdrawn by Lily worldwide following results of the PROWESS-SHOCK study that showed lack of efficacy (not because of toxicity like other drugs that have been withdrawn). |
External links
- CDER Report to the Nation: 2005 Has a list of U.S. withdrawals through 2005.
- Drug Recalls