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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 ...
Lacosamide, sold under the brand name Vimpat among others, is a medication used for the treatment of partial-onset seizures and primary generalized tonic-clonic seizures. [2] It is used by mouth or intravenously .
Lamotrigine prescribing information has a black box warning about life-threatening skin reactions, including Stevens–Johnson syndrome (SJS), DRESS syndrome, and toxic epidermal necrolysis (TEN). [5] The manufacturer states that nearly all cases appear in the first two to eight weeks of therapy. [5]
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 ...
When in December 2023, the FDA approved Bluebird Bio's Lyfgenia (lovotibeglogene autotemcel (lovo-cel)) cell-based gene therapy for sickle cell disease, a black box warning was included in the ...
(Reuters) -The U.S. health regulator on Monday asked a host of drugmakers, including Gilead Sciences, Johnson & Johnson and Novartis, to add a serious warning on the label of their cancer ...
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] Other side effects have included dizziness, somnolence, vertigo, aggression, anger, loss of coordination, blurred vision, irritability, and slurred speech. [8]
An earlier petition by Public Citizen in 2008 based on an analysis of 180 reports led to the FDA adding the current black box warning about the risk of Botox's effect spreading to other areas of ...