Table 4 Records of drugs withdrawn after ADRs observed in patient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Marketed drug | Dosage form | Withdrawn due to | Patient’s effected | References |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 13Â 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Tolrestat (Alredase) | Withdrawn not available | Proved as severe hepatotoxic agent | Not available | (Schonthal et al.2003) |
Terfenadine (Seldane) | Tablet withdrawn | Caused cardiac arrhythmias | 1.2% | (Orlando and Perkins2002) |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 1Â 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 | Â | 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% | |
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) |