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In the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears near the beginning of the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a 'box' or border around the text [1] to emphasize it is of ...
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The US Food and Drug Administration has warned that antidepressants may be linked with suicidal thoughts and behaviors among youth since 2003, leading to a black box warning for minors in 2005 and ...
The recall covers over 112,000 bottles distributed nationwide.
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Antidepressants could increase the risk of suicidal thoughts and behavior in people with depression under the age of 25. In 2004, the U.S. Food and Drug Administration along with the Neuro-Psychopharmacologic Advisory Committee and the Anti-Infective Drugs Advisory Committee, concluded that there was a causal link between newer antidepressants and pediatric suicidality. [7]
Last November, the U.S Food and Drug Administration said it had received reports of patients developing a type of T-cell blood cancer after being treated with CAR-T therapies.Truist Securities ...
It was the first antiepileptic drug in the class of selective non-competitive antagonist of AMPA receptors. [11] The drug label has a black box warning that the drug may cause serious psychiatric and behavioral changes; it may cause homicidal or suicidal thoughts. [8]