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...
The U.S. Food and Drug Administration has finalized new warning labels for over-the-counter painkillers, warning consumers of the risks of stomach... Read more »
The U.S. Food and Drug Administration (FDA) has issued warnings to nine companies for selling 14 unapproved narcotic pain medicines as part of an... Read more »
The U.S. Food and Drug Administration (FDA) has ordered a new warning label for the cholesterol medication Zocor (simvastatin), saying that the drug... Read more »
The FDA and CDC warned consumers not to eat any prepackaged Nestle Toll House refrigerated cookie dough because of the risk of contamination with E.... Read more »
Officials at the U.S. Food and Drug Administration (FDA) are warning consumers to avoid eating all products that contain peanut butter or peanut... Read more »