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Table 4 Records of drugs withdrawn after ADRs observed in patient

From: Adverse drug reactions monitoring: prospects and impending challenges for pharmacovigilance

Marketed drug Dosage form Withdrawn due to Patient’s effected References
Gatifloxacin Tablets, injectables Causes hyperglycemia and liver damage 1.2% (Carlo and Francesco1978)
Phenylpropanolamine Microcapsules, tablets, sustained release tablets Increased risk of stroke 0.01% (Gaudreault et al.1982)
Propoxyphene (Darvon) Capsule, tablet film coated Caused fatal heart rhythm abnormalities 0.8% (Delini et al.2007)
Sibutramine Capsule Increased cardiovascular risk 0.2% (Schluter1989)
Tegaserod Tablets Causes increased risk of heart attack 0.6% (Marx2006)
Nimesulide (below 13 years age) Tablets, oral suspension, gel, suppositories Caused life threatening hepatotoxic effects 1.3% (Gaudreault et al.1982)
Cisapride Tablets, oral suspension, capsules, medi-melt tablets, injections Risk of cardiac arrhythmias 0.03% (Solomon et al.2004)
Thalidomide Capsules Risk of teratogenicity 6-8% (Ito et al.2010)
Temafloxacin Tablets Caused allergic reactions and haemolyticanaemia 0.002- 0.04% (Delini et al.2007)
Alpidem Tablet- film coated, Proved to be hepatotoxic 0.6% (Gaudreault et al.1982)
Tolrestat (Alredase) Withdrawn not available Proved as severe hepatotoxic agent Not available (Schonthal et al.2003)
Terfenadine (Seldane) Tablet withdrawn Caused cardiac arrhythmias 1.2% (Orlando and Perkins2002)
Mibefradil (Posicor) Tablets Reported to cause drug interaction 123 death in 1 year (Holford1986)
Tolcapone Tablets Hepatotoxic in nature Not available (Delini et al.2007)
Astemizole Tablet Interaction with other drugs 0.2% (Holbrook et al.2005)
Troglitazone   Showed to be hepatotoxic 0.009% (Solomon et al.2004)
Cisapride Tablets, oral suspension, capsules, medi-melt tablets, injections Caused cardiac arrhythmias 80 deaths during clinical trial (Solomon et al.2004)
Trovafloxacin Oral tablets Liver failure cases reported 0.4% (Ito et al.2010)
Cerivastatin Tablets Caused rhadomyolysis Not available (Chyka et al.2007)
Rofecoxib (Vioxx) Tablets Myocardial infarction were reported 2-3% (He et al.2005) (Solomon et al.2004)
Valdecoxib (Bextra) Tablets Heart attack and stroke occurred 0.8% (Halpern2005)
Tegaserod (Zelnorm) Tablets Cardiovascular ischemic events occurred followed by heart attack and stroke 0.03% (Marx2006)
Aprotinin Tablets, injection Death occurred Not available (Marx2006)
Thioridazine Tablets Cardio toxicity occurred by its use Not available (Marx2006)
Sibutramine Capsule Cardiovascular risk increases by its use 0.2% (Schonthal et al.2003)