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 US Food and Drug Administration (FDA) has issued a warning to physicians that conventional antipsychotic medication, used to treat... Read more »
The FDA has once again informed consumers and healthcare professionals regarding the dangers associated with buying prescription drugs over... Read more »
Last week the U.S. Food and Drug Administration (FDA) announced the approval of revised labeling for the prescription weight-loss drug... Read more »
[Humor] The recent kerfuffle over the diabetes drug Avandia has caused the FDA to ask the drug company that makes Avandia and a similar... Read more »
Over the last several months, there have been reports that the FDA was considering new warnings for neuronal stabilizing agents... Read more »
Q: What is Zicam and how does it work?A: Zicam is an over-the-counter product that contains zinc and is used to reduce both the duration and the... 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 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 »
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 »