Table 1.
Safety withdrawals for new molecular entities approved by FDA in 1997
| New drug | Date approved | Date withdrawn | Reason for withdrawal |
|---|---|---|---|
| Troglitazone | 29 Jan 1997 | 21 Mar 2000 | Liver toxicity |
| Mibefradil | 20 Jun 1997 | 8 Jun 1998 | Fatal arrhythmias |
| Cerivastatin | 26 Jun 1997 | 8 Aug 2001 | Rhabdomyolysis, renal failure |
| Bromfenac | 15 Jul 1997 | 22 Jun 1998 | Severe hepatitis, liver failure |
| Sibutramine | 22 Nov 1997 | 8 Oct 2010 | Risk of heart attack, stroke |
| Trovafloxacin | 18 Dec 1997 | 16 Jun 2006 | Liver toxicity |
| Alatrofloxacin | 18 Dec 1997 | 16 Jun 2006 | Liver toxicity |