摘要: 1While the FDA acted within days of receiving heart valve data, fenfluramine had been approved 24 years earlier. 2 In December 1997, popular nonsedating antihistamine terfenadine was withdrawn because a safer alternative existed without terfenadine’s risk potentially lethal cardiac arrhythmia. 3 Terfenadine on market for 12 years. Discovering new dangers drugs after marketing is common. Overall, 51% have serious adverse effects not detected prior to approval. 4 Merely discovering by itself sufficient protect public. Each year prescription injure 1.5 million people so severely they require hospitalization and 100 000 die, making leading cause death in United States. 5