Ashworth L
Mercer University's Southern School of Pharmacy, Atlanta, GA 30341-4155, USA.
Home Care Provid. 1997 Jun;2(3):117-20. doi: 10.1016/s1084-628x(97)90134-9.
The Food and Drug Administration (FDA) has announced its intention to withdraw the approval of terfenadine (Seldane), terfenadine with pseudoephedrine (Seldane D), and generic versions of terfenadine. Before granting approval for the marketing of fexofenadine (Allegra), terfenadine's active metabolite, the FDA determined terfenadine's benefits outweight its risks, despite its, known potential for serious cardiac effects.
美国食品药品监督管理局（FDA）已宣布打算撤销对特非那定（息斯敏）、含伪麻黄碱的特非那定（Seldane D）以及特非那定仿制药的批准。在批准特非那定的活性代谢物非索非那定（开瑞坦）上市之前，FDA认定，尽管特非那定已知有严重心脏不良反应的潜在风险，但其益处大于风险。
