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Overview
-Regulation of OTC Drugs
-Regulatory History of Hydrocortisone
-Current Labeling of Hydrocortisone
Regulatory History of Hydrocortisone
Serious Adverse Events (1952-1973)
-1960: Temporary growth retardation in 5.5 year old
1% hydrocortisone for 16 months
-1962: Temporary growth retardation in infant
1% hydrocortisone twice daily for 6 months (total body)
-1966: Rapid gain in body weight in 3-week old
0.25% hydrocortisone three times daily for 8.5 days
2100 mg/m2 body surface area
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