Category Archives: FDA Black Box WarningNotice of FDA warning requiring manufacturers of two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a boxed warning on the products’ labels. The agency is requiring this action after receiving reports of bad side effects in children who were exposed to testosterone by accident through contact with another person being treated with these products (secondary exposure).
Experts Suggest Link Between Warnings and Startling New Trend Suicide rates for preteens and teenagers increased sharply when the Food and Drug Administration slapped a “black box” warning on anti-depressants and doctors started writing fewer prescriptions for young people, according to federal data released Thursday. The FDA’s warning, publicly debated in 2003 and enacted in [...]
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