List of withdrawn drugs
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Some drugs have been withdrawn from the market because of risks to the patients.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.
[edit] Significant withdrawals
| Drug name | Withdrawn | Remarks |
|---|---|---|
| Thalidomide | 1950s–1960s | Withdrawn because of risk of teratogenicity; returned to market for use in leprosy and multiple myeloma under FDA orphan drug rules |
| Lysergic acid diethylamide (LSD) | 1950s–1960s | Marketed as a psychiatric drug; withdrawn after it became widely used recreationally |
| Diethylstilbestrol | 1970s | Withdrawn because of risk of teratogenicity |
| Phenformin and Buformin | 1978 | Withdrawn because of risk of lactic acidosis |
| Ticrynafen | 1982 | Withdrawn because of risk of hepatitis |
| Zimelidine | 1983 | Withdrawn worldwide because of risk of Guillain-Barré syndrome |
| Phenacetin | 1983 | An ingredient in "A.P.C." tablet; withdrawn because of risk of cancer and kidney disease |
| Methaqualone | 1984 | Withdrawn because of risk of addiction and overdose |
| Nomifensine (Merital) | 1986 | Withdrawn because of risk of hemolytic anemia |
| Triazolam | 1991 | Withdrawn in the United Kingdom because of risk of psychiatric adverse drug reactions. This drug continues to be available in the U.S. |
| Terodiline (Micturin) | 1991 | Prolonged QT interval |
| Temafloxacin | 1992 | Withdrawn in the United States because of allergic reactions and cases of hemolytic anemia, leading to three patient deaths.[1] |
| Flosequinan (Manoplax) | 1993 | Withdrawn in the United States because of an increased risk of hospitalization or death |
| Alpidem (Ananxyl) | 1996 | Withdrawn because of rare but serious hepatotoxicity. |
| Chlormezanone (Trancopal) | 1996 | Withdrawn because of rare but serious cases of toxic epidermal necrolysis |
| Fen-phen (popular combination of fenfluramine and phentermine) | 1997 | Phentermine remains on the market, dexfenfluramine and fenfluramine – later withdrawn as caused heart valve disorder |
| Tolrestat (Alredase) | 1997 | Withdrawn because of risk of severe hepatotoxicity |
| Terfenadine (Seldane, Triludan) | 1998 | Withdrawn because of risk of cardiac arrhythmias; superseded by fexofenadine |
| Mibefradil (Posicor) | 1998 | Withdrawn because of dangerous interactions with other drugs |
| Etretinate | 1990s | Risk of birth defects; narrow therapeutic index |
| Tolcapone (Tasmar) | 1998 | Hepatotoxicity |
| Temazepam (Restoril, Euhypnos, Normison, Remestan, Tenox, Norkotral) | 1999 | Withdrawn in Sweden and Norway 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 (Hismanal) | 1999 | Arrhythmias because of interactions with other drugs |
| Grepafloxacin (Raxar) | 1999 | Prolonged QT interval |
| Troglitazone (Rezulin) | 2000 | Withdrawn because of risk of hepatotoxicity; superseded by pioglitazone and rosiglitazone |
| Alosetron (Lotronex) | 2000 | Withdrawn because of risk of fatal complications of constipation; reintroduced 2002 on a restricted basis |
| Cisapride (Propulsid) | 2000s | Withdrawn in many countries because of risk of cardiac arrhythmias |
| Amineptine (Survector) | 2000 | Withdrawn because of hepatotoxicity, dermatological side effects, and abuse potential. |
| Phenylpropanolamine (Propagest, Dexatrim) | 2000 | Withdrawn because of risk of stroke in women under 50 years of age when taken at high doses (75 mg twice daily) for weight loss. |
| Trovafloxacin (Trovan) | 2001 | Withdrawn because of risk of liver failure |
| Cerivastatin (Baycol, Lipobay) | 2001 | Withdrawn because of risk of rhabdomyolysis |
| Rapacuronium (Raplon) | 2001 | Withdrawn in many countries because of risk of fatal bronchospasm |
| Rofecoxib (Vioxx) | 2004 | Withdrawn because of risk of myocardial infarction |
| Co-proxamol (Distalgesic) | 2004 | Withdrawn in the UK due to overdose dangers. |
| mixed amphetamine salts (Adderall XR) | 2005 | Withdrawn in Canada because of risk of stroke. 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) | 2005 | Withdrawn because of a high risk of accidental overdose when administered with alcohol |
| Thioridazine (Melleril) | 2005 | Withdrawn from U.K. market because of cardiotoxicity |
| Pemoline (Cylert) | 2005 | Withdrawn from U.S. market because of hepatotoxicity |
| Natalizumab (Tysabri) | 2005–2006 | Voluntarily withdrawn from U.S. market because of risk of Progressive multifocal leukoencephalopathy (PML). Returned to market July, 2006. |
| Ximelagatran (Exanta) | 2006 | Withdrawn because of risk of hepatotoxicity (liver damage). |
| Pergolide (Permax) | 2007 | Voluntarily withdrawn in the U.S. because of the risk of heart valve damage. Still available elsewhere. |
| Tegaserod (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 (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 (Prexige) | 2007–2008 | Progressively withdrawn around the world because of serious side effects, mainly liver damage |
| Rimonabant (Acomplia) | 2008 | Withdrawn around the world because of risk of severe depression and suicide |
| Efalizumab (Raptiva) | 2009 | Withdrawn because of increased risk of progressive multifocal leukoencephalopathy; to be completely withdrawn from market by June 2009 |
| Sibutramine (Reductil/Meridia) | 2010 | Withdrawn in Europe, Australasia, Canada, and the U.S. because of increased cardiovascular risk |
| Gemtuzumab ozogamicin (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 (Avandia) | 2010 | Withdrawn in Europe because of increased risk of heart attacks and death. This drug continues to be available in the U.S. |
[edit] External links
- CDER Report to the Nation: 2005 Has a list of U.S. withdrawals through 2005.
- Drug Recalls
