Innovative thinking of clinical investigation for rare disease drug development

Table 1 Top ten prescribed drugs withdrawn by FDA between 1993 and 2010 (Source: Saluja et al.) [8]

Drug name	Use for	Company	Reasons	Years on market	Visit times\({^a}\)
Rofecoxib	COX-2 selective nonsteroidal anti-inflammatory drug	Merck & Co.	Heart attack and stroke risk	1999–2004	10647
Valdecoxib	Nonsteroidal anti-inflammatory drug	G. D. Searle & Company	Stevens-Johnson syndrome and cardiovascular risk	2001–2005	5612
Cisapride	Gastroprokinetic agent	Janssen Pharmaceuticals	Cardiac toxicity	1993–1999	2196
Troglitazone	Antidiabetic and anti-inflammatory drug	Parke-Davis	Hepatic failure	1997–2000	1976
Gatifloxacin	Antibiotic of the fourth-generation fluoroquinolone family	Kyorin Pharmaceutical Company	Hypoglycemia and hyperglycemia	1999–2003	1332
Tegaserod	A \(\text {5-HT}_4\) agonist	Novartis	Cardiovascular risk	2002–2007	980
Cerivastatin	A synthetic lipid-lowering agent	Bayer A.G.	Kidney failure	1997–2001	968
Trovafloxacin	A broad-spectrum antibiotic	Pfizer	Hepatic toxicity	1997–2000	645
Bromfenac	Nonsteroidal anti-inflammatory drug	ISTA Pharmaceuticals	Hepatic failure	1997–1998	434
Mibefradil	Nonselective calcium channel blocker	Roche	Drug interactions	1997–1998	409

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