Drug withdrawals
From Ganfyd
| Year | Name | Trade Name | Comment |
|---|---|---|---|
| 1961 | thenalidine | Sandostene® | Agranulocytosis |
| 1961[2] | thalidomide | Distavel®, Valgis®, Valgraine®,
Asmaval®, Tensival® | A sedative drug, also marketed for morning sickness that produced fetal malformation. At the time the promotional material in some markets emphasised its safety in pregnancy !. It has recently been reintroduced to the market as an immunosuppressant and is used to treat leprosy. |
| 1961 (FDA) | iproniazid | Marsilid®, Iprozid®, Ipronid®, Rivivol®, Propilniazida® | Hepatotoxic, the first MAOI originally developed to treat tuberculosis. |
| 1964 | benziodarone | Hepatotoxicity | |
| 1966 (FDA) | sulfadimethoxine | Madricidin® | Stevens-Johnson syndrome |
| 1966 (FDA) | aminoglutethimide | Reintroduced for malignant tumours/Cushings | |
| 1968 | ibufenac | Hepatotoxicity | |
| 1970 | chlormadinone | Estalor-21®, C-Quens® | Mammary tumours in dogs (FDA withdrawal 1972) |
| 1970 | megestrol | Animal toxicity | |
| 1971 | diethylstilbestrol (DES) stilboestrol | It induced cervical and vaginal cancer in the female children of treated mothers as well as genital malformation in its previous indication to prevent miscarriage. Now used rarely to treat prostate cancer and breast cancer in postmenopausal woman. DESs use in farming practice is controversial and it has the potential to be an environmental toxin. | |
| 1975 | practolol | Eraldin® | Fibrinous peritonitis & blindness |
| 1975 | aminopyrine | Bone marrow suppression (withdrawn by FDA 1970) | |
| 1975 | polidexide | Long term animal toxicity | |
| 1976 (FDA) | chloroform | Carcinogenic potential | |
| 1977 | dipyrone | Dimethone® | Agranulocytosis |
| 1978 | oxyphenisatine | Lavema® | Hepatitis, jaundice (withdrawn FDA 1973) |
| 1979 | alclofenac | animal toxicity (withdrawn FDA 1973) | |
| 1979 | methapyrilene | Long term animal toxicity | |
| 1980 | phenacetin | Renal tubular necrosis, haemolytic anaemia (FDA withdrawal 1983) | |
| 1981 | clioquinol | Neurotoxicity (withdrawn by FDA 1973) | |
| 1982 | benoxaprofen | Opren® | A NSAID it caused hepatotoxicity and was perhaps the most significant NSAID withdrawals before rofecoxib. There have been ten or more NSAIDs withdrawn |
| 1982 | zimeldine | Zelmid® Normud® | The first SSRI it caused Guillain-Barre syndrome and a hypersensitivity syndrome so was withdrawn the same year as authorised in UK. |
| 1982 | phenformin | Lactic acidosis | |
| 1982 | methandrostenolone | endocrine side effects | |
| 1983 | Indoprofen | Long term animal toxicity | |
| 1983 | propanidid | Anaesthetic agent with hypersensitivity reactions | |
| 1983 | zimeldine | Normud®, Zelmid® | Guillian-Barre syndrome and hypersensitivity reactions killed it within a year of launch as first SSRI |
| 1984 | oxyphenbutazone | Tandearil® | Blood dyscrasias (FDA withdrawal 1985) |
| 1984 | fenclofenac | long term animal toxicity | |
| 1984 | feprazone | multiple toxicities | |
| 1986 | aspirin (paediatric) | Use withdrawn in children due to Reye's syndrome | |
| 1986 | nomifensine | Merital)® | Haemolytic anaemia |
| 1986 | sulphamethoxypyridazine | blood disorders | |
| 1987 | danthron | carcinogenic in animals. Still licensed for terminal illness | |
| 1987 | suprofen | Nephrotoxicity | |
| 1989 | prenylamine | ventricular tachycardia it was the first of many withdrawn because of torsade de pointes | |
| 1990 | metipranolol | eye damage | |
| 1990 | tryptophan | L-tryptophan | eosinophilia-myalgia syndrome due to contamination (most believe) |
| 1991 | triazolam | Halcion® | A benzodiazepine used for sedation that produced psychiatric problems like acute psychosis, paranoia and confusion. Still licensed by FDA |
| 1991 | terodiline | Micturin® | Torsade de pointes |
| 1992 | temafloxacin | Multiple toxicities | |
| 1997 | troglitazone | Romozin® UK, Rezulin® USA | First glitazone on the UK market for a few months it was discontinued by Glaxo Wellcome because of hepatotoxicity. The FDA allowed it to remain until 2000 on the US market earning Warner-Lambert about $2 billion in sales and causing about 90 cases of severe hepatic failure worldwide. |
| 1998 | mibefradil | Posicor® | A calcium channel blocker. It interacted with far too many other drugs used for cardiological conditions which enhanced its proarrhythmic potential. |
| 2000 | cisapride | Propulsid® | A drug that encouraged gastric motility and fatal arrythmias. |
| 2001 | cerivastatin | Lipobay® | A statin with ten times the rate of myopathy than other marketed drugs of the class. |
| 2004 | rofecoxib | Vioxx® | Withdrawn when a cancer prevention trial confirmed suspicions that in long term use it it had a 2-3 times increased risk of myocardial infarction.[3] Coxibs subsequently have been determined by the EMEA to be contraindicated in those with ischaemic heart disease |
| 2005(FDA) | natalizumab | Tysabri® | An anti-α4,β1 integrin monoclonal antibody which was withdrawn before European approvial but after FDA approvial when 3 cases of progressive multifocal leukoencephalopathy had occurred amongst 3000 treated in RCT and 5000 treated in all. At the time EMEA rules were tighter than FDA rules. |
| 2005 | co-proxamol | Distalgesic®, Cosalgesic® | An analgesic combination of dextropropoxyphene and paracetamol which has been withdrawn because of its toxicity in overdose. Some patients found it beneficial to them, despite little evidence for acute analgesia benefit compared to paracetamol alone. |
| 2005 | valdecoxib | Bextra® | Withdrawn when the combination of skin reactions and not so good cardiovascular safety got too much. A coxib. |
| 2006 | ximelagatran | Exanta® | A potential blockbuster anticoagulant that wasn't. Withdrawn due to hepatic toxicity. License refused by FDA in 2004, but development because of potential to replace warfarin in some common indications had continued. At time of withdrawal not marketed in UK, but licensed in EU (2003) and marketed in 10 Western European countries, Brazil and Argentina. |
| 2007 | tegaserod | Zelmid® | Marketed widely throughout the world for upper gut dysmotility, but not in UK. FDA asked for withdrawal because of reports of cardiac ischaemia [4] |
| 2007 | lumiracoxib | Prexige® | Withdrawn in Australasia and Canada and a few months later in EU[5] A coxib. |
| 2007 | inhaled insulin | Exubera® | Withdrawn October as insufficient market penetration[6] |
| 2007 | carisoprodol | Carisoma® | Withdrawn in EU November 2007 due to abuse potential |
| 2007 | aprotinin | Trasylol® | Withdrawn in EU 2007 as outcomes worse than competing products |
| 2008 | rimonabant | Acomplia® | Withdrawn in EU 2008 as depression and suicide risk not predictable. Never had FDA approval. |
| 2009 | Efalizumab | Raptiva® | Withdrawn in EU Feb 2009 due to 3 cases of progressive multifocal leukoencephalopathy[7] |
| 2010 | Sibutramine | Reductil® | Withdrawn in EU Jan 2010 due to the required post marketing surveillance SCOUT study showing excess cardiovascular mortality [8] |
This list is not meant to be exhaustive and can be made inaccurate by further developments in the evidence base[9]. The issues are often relative, so that a drug such as chloramphenicol has not been available in France since 1978 but is still available in UK and USA despite known risk aplastic anaemia.
References
- ↑ http://www.nuffieldbioethics.org/fileLibrary/pdf/pg_187_88_Box_8.7.pdf UK withdrawals 1961-1992
- ↑ Hayman DJ. Withdrawal of Thalidomide (" Distaval ") BMJ 2 Dec. 1961:1499
- ↑ Bresalier RS, Sandler RS, Quan H, Bolognese JA, Oxenius B, Horgan K, et al. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. The New England journal of medicine. 2005;352:1092-102. (Direct link – subscription may be required.)
- ↑ http://www.cnn.com/2007/HEALTH/03/30/constipation.drug.ap/
- ↑ [1]
- ↑ Official Pfizer announcement
- ↑ MHRA Efalizumab withdrawal
- ↑ MHRA withdrawal of sibutramine
- ↑ Wysowski DK, Swartz L. Adverse Drug Event Surveillance and Drug Withdrawals in the United States, 1969-2002 ,Arch Intern Med 2005;165:1363-1369
