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Frances Oldham Kelsey Pediatric Pharmacology: Chloramphenicol Death of three newborn infants in 1960 Followed administration of moderately large amounts of chloramphenicol Recommended IM dose of microcrystalline suspension was 100 to 150 mg/kg/day for children of 15 kg or less One death at dose of 220 mg/kg/day for 2.5 days One death at dose of 23o mg for 3 days Recommended oral dose of chloramphenicol palmitate suspension was 50 - 150 mg/kg/day for children of 15 kg or less One death at dose o 50 mg/kg/day for 2.7 days and 10 hr after a single inadvertent dose of 400 mg Kefauver-Harris Amendment Thalidomide: 10,000 deformities in 46 countries Chloramphenicol: Children deaths Initiated 1962 Amendment to US Food, Drug and Cosmetics Act Before marketing firms must prove safety and effectiveness for proposed use, and disclose potential side effects Pediatric pharmacology: Whats unique