“Boxed warnings” or “black boxes” are the strictest FDA label warnings. They appear on cigarettes, fluoroquinolones (for tendon rupture), Lamictal (for SJS and TEN), Accutane (birth defects), and other products with well-known risks. The industry obviously dislikes black boxes since they reduce sales (though their lobbyists charge the boxes “confuse” and “unnecessarily alarm” patients). So […]
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