Why the Time Has Come to Withdraw Seldane from the Market

Seldane (terfenadine) and Hismanal (astemizole) were introduced to clinical practice approximately 12 years ago as the first non-sedating antihistamines. This benefit -- lack of sedation -- changed the way we thought of antihistamine safety, but created new problems. Because antihistamine dosing was no longer limited by unwanted sedation, dosages often were increased above approved limits to achieve therapeutic goals. However, dose-dependent cardiac toxicity from an overdose of terfenadine was first reported in 1989.

This past January, the Food and Drug Administration proposed the removal of terfenadine (Seldane and other brands) from the market, stating that "terfenadine's benefits are no longer considered to outweigh its risks."1 This prop…