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
| Drug name |
Withdrawn |
Remarks |
ThalidomideThalidomide is a sedative-hypnotic and multiple myeloma medication. The drug is a potent teratogen in rabbits and primates including humans: severe birth defects may result if the drug is taken during pregnancy....
|
1950s–1960s |
Withdrawn because of risk of teratogenicity; returned to market for use in leprosyLeprosy , or Hansen's disease , is a chronic disease caused by the bacteria Mycobacterium leprae and Mycobacterium lepromatosis. Leprosy is primarily a granulomatous disease of the peripheral nerves and mucosa of the upper respiratory tract; skin lesions are the primary external symptom...
and multiple myelomaMultiple myeloma , also known as MM, myeloma, plasma cell myeloma, or as Kahler's disease is a cancer of the white blood cells known as plasma cells. A type of B cell, plasma cells are a crucial part of the immune system responsible for the production of antibodies in humans and other vertebrates...
under FDA orphan drugAn 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Marketed as a psychiatric cure-all; withdrawn after it became widely used recreationally |
| Diethylstilbestrol Diethylstilbestrol is a drug, an orally active synthetic nonsteroidal estrogen that was first synthesized in 1938. In 1971 it was found to be a teratogen when given to pregnant women.-Synthesis:...
|
1970s |
Withdrawn because of risk of teratogenicity |
PhenforminPhenformin is an anti-diabetic drug from the biguanide class. Marked under the brand name Debeone, it is no longer widely available because it is known to induce lactic acidosis....
and BuforminBuformin is an anti-diabetic drug of the biguanide class, it is chemically related to metformin, and phenformin. It was withdrawn from the market in most countries due to a high risk of causing lactic acidosis....
|
1978 |
Withdrawn because of risk of lactic acidosisLactic acidosis is a condition caused by the buildup of lactic acid in the body. It leads to acidification of the blood , and is considered a distinct form of metabolic acidosis. Tissue hypoxia and hypoperfusion force cells to breakdown glucose anaerobically. The result is lactic acid formation...
|
| 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 hepatitisHepatitis implies injury to the liver characterized by the presence of inflammatory cells in the tissue of the organ. The name is from ancient Greek hepar , the root being hepat- , meaning liver, and suffix -itis, meaning "inflammation"...
|
ZimelidineZimelidine 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 is an acute inflammatory demyelinating polyneuropathy , an autoimmune disorder affecting the peripheral nervous system, usually triggered by an acute infectious process. It is included in the wider group of peripheral neuropathies...
|
PhenacetinPhenacetin is an analgesic, but its use has declined owing to its association with several adverse side effects, some of which are described in the following. Typical doses are 300mg to 500mg a day.-History:...
|
1983 |
An ingredient in "A.P.C." tablet; withdrawn because of risk of cancer and kidney disease |
MethaqualoneMethaqualone is a sedative drug that is similar in effect to barbiturates, a general CNS depressant. Its use peaked in the 1960s and 1970s as a hypnotic, for the treatment of insomnia, and as a sedative and muscle relaxant...
|
1984 |
Withdrawn because of risk of addiction The term "addiction" is used in many contexts to describe an obsession, compulsion, or excessive psychological dependence, such as: drug addiction The term "addiction" is used in many contexts to describe an obsession, compulsion, or excessive psychological dependence, such as: drug addiction The...
and overdose |
NomifensineNomifensine maleate is a norepinephrine-dopamine reuptake inhibitor test-marketed in the United States by Hoechst AG that increases the amount of synaptic dopamine available to receptors by blocking dopamine's re-uptake transporter...
(Merital) |
1986 |
Withdrawn because of risk of hemolytic anemia |
TriazolamTriazolam is a benzodiazepine derivative drug. It possesses pharmacological properties similar to that of other benzodiazepines, but it is generally only used as a sedative to treat insomnia...
|
1991 |
Withdrawn in the United KingdomThe United Kingdom of Great Britain and Northern Ireland is a sovereign state located off the northwestern coast of continental Europe. It is an island country, spanning an archipelago including Great Britain, the northeastern part of Ireland, and many small islands...
because of risk of psychiatric adverse drug reactionAn adverse drug reaction is an expression that describes harm associated with the use of given medications at a normal dose. The meaning of this expression differs from the meaning of "side effect", as this last expression might also imply that the effects can be beneficial...
s. This drug continues to be available in the U.S. |
| Temafloxacin Temafloxacin , is a fluoroquinolone antibiotic drug which was withdrawn from sale in the U.S...
|
1992 |
Withdrawn in the United States because of allergic reactions and cases of hemolytic anemia Hemolytic anemia is anemia due to hemolysis, the abnormal breakdown of red blood cells either in the blood vessels or elsewhere in the body . It has numerous possible causes, ranging from relatively harmless to life-threatening. The general classification of hemolytic anemia is either acquired or...
, leading to three patient deaths.http://www.fda.gov/bbs/topics/NEWS/NEW00279.html |
| 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 |
AlpidemAlpidem 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.Alpidem is a fairly recently...
(Ananxyl) |
1996 |
Withdrawn because of rare but serious 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...
. |
| Fen-phen Fen-phen was an anti-obesity medication which consisted of two drugs: fenfluramine and phentermine. Fenfluramine, and later, a related drug, dexfenfluramine, was marketed by American Home Products, now known as Wyeth, but were shown to cause potentially fatal pulmonary hypertension and heart valve...
(popular combination of fenfluramineFenfluramine is a drug that was part of the Fen-Phen anti-obesity medication . Also known as Pondimin, fenfluramine was introduced on the U.S. market in 1973. It is the racemic mixture of two enantiomers, dextrofenfluramine and levofenfluramine...
and phenterminePhentermine, a contraction for "phenyl-tertiary-butylamine", is an appetite suppressant of the amphetamine and phenethylamine class....
) |
1997 |
Phentermine remains on the market, dexfenfluramine Dexfenfluramine, also marketed under the name Redux, is a serotoninergic anorectic drug. It was for some years in the mid-1990s approved by the United States Food and Drug Administration for the purposes of weight loss. However, following multiple concerns about the cardiovascular side-effects of...
and fenfluramine – later withdrawn as caused heart valveIn anatomy, the heart valves maintain the unidirectional flow of blood in the heart by opening and closing depending on the difference in pressure on each side...
disorder |
| Tolrestat Tolrestat is an aldose reductase inhibitor which was approved for the control of certain diabetic complications.It was discontinued by Wyeth in 1997 because of the risk of severe liver toxicity and death. It was sold under the tradename Alredase....
(Alredase) |
1997 |
Withdrawn because of risk of severe 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 is an antihistamine formerly used for the treatment of allergic conditions. It was marketed under various brand names including Seldane in the United States, Triludan in the United Kingdom, and Teldane in Australia...
(Seldane) |
1998 |
Withdrawn because of risk of cardiac arrhythmias; superseded by fexofenadineFexofenadine is an antihistamine drug used in the treatment of hayfever and similar allergy symptoms. It was developed as a successor of and alternative to terfenadine , an antihistamine with potentially serious contraindications...
|
| 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 |
EtretinateEtretinate is a medication used to treat severe psoriasis. It was removed from the United States market in 1998 and the Canadian market in 1996, due to the high risk of birth defects....
|
1990s |
Risk of birth defects; narrow therapeutic index |
| Temazepam Temazepam is an intermediate-acting 3-hydroxy benzodiazepine. It is generally prescribed for the short-term treatment of sleeplessness in patients who have difficulty maintaining sleep. Temazepam is not effective for induction of sleep...
(Restoril, Euhypnos, Normison, Remestan, Tenox, Norkotral) |
1999 |
Withdrawn in SwedenSweden , officially the Kingdom of Sweden , is a Nordic country on the Scandinavian Peninsula in Northern Europe...
and NorwayNorway , officially the Kingdom of Norway, is a country in Northern Europe occupying the western portion of the Scandinavian Peninsula, as well as Jan Mayen and the Arctic archipelago of Svalbard under the Spitsbergen Treaty...
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 the U.S. |
AstemizoleAstemizole is a second generation antihistamine drug which has a long duration of action. Astemizole was discovered by Janssen Pharmaceutica in 1977.-Metabolism:It is metabolized by CYP3A4....
(Hismanal) |
1999 |
Arrhythmias because of interactions with other drugs |
| 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.. It was introduced and manufactured by Parke-Davis in the late 1990s but turned out to be associated with an idiosyncratic reaction leading...
(Rezulin) |
2000 |
Withdrawn because of risk of 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 pioglitazonePioglitazone is a prescription drug of the class thiazolidinedione with hypoglycemic action.Pioglitazone is marketed as trademarks Actos in the USA, Glustin in Europe, Zactos in Mexico by Takeda Pharmaceuticals & Piozer in Pakistan by Hilton Pharmaceuticals.-Pharmacology:Pioglitazone selectively...
and rosiglitazoneRosiglitazone is an anti-diabetic drug in the thiazolidinedione class of drugs. It is marketed by the pharmaceutical company GlaxoSmithKline as a stand-alone drug and in combination with metformin or with glimepiride . Annual sales peaked at approx $2.5bn in 2006...
|
AlosetronAlosetron is a 5-HT 3 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 constipationConstipation, costiveness, or irregularity is a condition of the digestive system in which a person experiences hard feces that are difficult to expel. This usually happens because the colon absorbs too much water from the food...
; reintroduced 2002 on a restricted basis |
CisaprideCisapride is a parasympathomimetic and gastroprokinetic agent that acts as a serotonin 5-HT 4 receptor agonist. Stimulation of the serotonin receptors increases acetylcholine release in the enteric nervous system. It is sold under the trade names Prepulsid and Propulsid...
(Propulsid) |
2000s |
Withdrawn in many countries because of risk of cardiac arrhythmias |
AmineptineAmineptine is an atypical tricyclic antidepressant that selectively inhibits the reuptake of dopamine and to a lesser extent norepinephrine, thus exerting a powerful and fast-acting antidepressant effect.Introduced in France in 1978 by the pharmaceutical giant Servier and marketed...
(Survector) |
2000 |
Withdrawn because of 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 abuseDrug abuse has a huge range of definitions related to taking a psychoactive drug or performance enhancing drug for a non-therapeutic or non-medical effect. All of these definitions imply a negative judgement of the drug use in question...
potential. |
| Phenylpropanolamine Phenylpropanolamine , also known as norephedrine and oxyamphetamine, 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 and cold preparations...
(Propagest, DexatrimDexatrim is a dietary supplement meant to assist with weight loss. Its formula has changed over the years and at times Dexatrim has contained phenylpropanolamine and ephedra. As of 2007, it contains 200 milligrams caffeine per pill and extracts of cocoa and green tea leaf as well as several...
) |
2000 |
Withdrawn because of risk of strokeA stroke 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 thrombosis or embolism or due to a hemorrhage...
in women under 50 years of age when taken at high doses (75mg twice daily) for weight loss. |
TrovafloxacinTrovafloxacin 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 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...
|
cerivastatinIn pharmacology, cerivastatin was a synthetic member of the class of statins, used to lower cholesterol and prevent cardiovascular disease. Cerivastatin was marketed by the pharmaceutical company Bayer A.G. in the late 1990s as a new synthetic statin, to compete with Pfizer's highly successful...
(Baycol, Lipobay) |
2001 |
Withdrawn because of risk of rhabdomyolysisRhabdomyolysis is the rapid breakdown of skeletal muscle due to injury to muscle tissue. The muscle damage may be caused by physical , chemical, or biological factors...
|
| Rapacuronium Rapacuronium bromide is a rapidly acting, non-depolarizing neuromuscular blocker 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 bronchospasmBronchospasm 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...
|
RofecoxibRofecoxib 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 infarctionMyocardial infarction or acute myocardial infarction , commonly known as a heart attack, is the interruption of blood supply to part of the heart, causing some heart cells to die...
|
| mixed amphetamine salts (Adderall XR) Adderall is a brand-name psychostimulant medication composed of amphetamine and dextroamphetamine, which is thought to work by increasing the amount of dopamine and norepinephrine in the brain. Adderall is widely reported to increase alertness, libido, concentration and overall cognitive...
|
2005 |
Withdrawn in CanadaCanada is a country occupying most of northern North America, extending from the Atlantic Ocean in the east to the Pacific Ocean in the west and northward into the Arctic Ocean...
because of risk of strokeA stroke 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 thrombosis or embolism or due to 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, a more common synonym for dihydromorphinone and dimorphone, commonly a hydrochloride is a potent centrally-acting analgesic drug of the opioid class. It is a derivative of morphine, specifically a hydrogenated ketone thereof and therefore a semi-synthetic drug...
|
2005 |
Withdrawn because of a high risk of accidental overdose when administered with alcohol |
| Pemoline Pemoline is 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 |
NatalizumabNatalizumab 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 , 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...
(PML). Returned to market July, 2006. |
| 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 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). |
PergolidePergolide is an ergoline-based dopamine receptor agonist used for the treatment of Parkinson's disease.Parkinson's disease is associated with low levels of the neurotransmitter dopamine in the brain...
(Permax) |
2007 |
Voluntarily withdrawn in the U.S. because of the risk of heart valve In anatomy, the heart valves maintain the unidirectional flow of blood in the heart by opening and closing depending on the difference in pressure on each side...
damage. Still available elsewhere. |
TegaserodTegaserod is a 5-HT 4 agonist manufactured by Novartis and used for the management of irritable bowel syndrome and constipation. Its use was the only drug approved by the United States Food and Drug Administration to help relieve the abdominal discomfort, bloating and constipation...
(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, also known as bovine pancreatic trypsin inhibitor, BPTI is a protein, that is used as medication administered by injection to reduce bleeding during complex surgery, such as heart and liver surgery. Its main effect is the slowing down of fibrinolysis, the process that leads to the...
(Trasylol) |
2007 |
Withdrawn because of increased risk of complications or death; permanently withdrawn in 2008 except for research use |
LumiracoxibLumiracoxib 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...
|
2007-2008 |
Progressively withdrawn around the world because of serious side effects, mainly liver damage |
RimonabantRimonabant is an anorectic anti-obesity drug. It is an inverse agonist for the cannabinoid receptor CB1...
(Accomplia) |
2008 |
Withdrawn around the world because of risk of severe depression and suicide |
| Efalizumab Efalizumab is a medication designed to treat psoriasis. As its name implies, it is a recombinant humanized monoclonal antibody that binds to CD11a and acts as an immunosuppressant. It is administered once weekly by subcutaneous injection. It acts to inhibit white blood cell migration out of blood...
(Raptiva) |
2009 |
Withdrawn because of increased risk of progressive multifocal leukoencephalopathy; to be completely withdrawn from market by June 2009 |
Has a list of U.S. withdrawals through 2005 [