What exactly is a "black box" warning?
Simply put, it's the strongest warning that the U.S. Food and Drug Administration (FDA) can require on a drug's packaging. The FDA requires the black box warning when studies suggest a drug can cause a serious or life-threatening side effect. The text of the warning is set apart from other information in a black box, so that doctors, pharmacists, and patients can easily see it.
What did the FDA advisory panel recommend?
The FDA itself hasn't made a...
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