How can one tell if the FDA has approved a drug as safe for a particular use?
Only those uses of a drug which are mentioned in the “Indications” section of the package insert are FDA- approved uses of the drug The fact that a use of a drug is mentioned in a section of the package insert other than the “Indications” section does NOT in itself, indicate FDA approval of that use. If, for example, the section of the package insert entitled “Usage in Pregnancy/Obstetrics” mentions the use of the drug during pregnancy, obstetrics (labor and delivery), or lactation but such uses are not specifically mentioned in the “Indications” section, then the FDA has NOT approved the drug as safe for use in pregnancy, labor, delivery, or lactation. Absence of contraindication(s) no guarantee of safety. The absence of a contraindication to a specific use or condition such as infancy, childhood, pregnancy, elderly, etc., in the package insert does not mean that the FDA has approved the drug as safe for that intended use. How does the FDA determine whether a drug is safe? FDA relies
