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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 its ...
Clindamycin is a lincosamide antibiotic medication used for the treatment of a number of bacterial infections, including osteomyelitis (bone) or joint infections, pelvic inflammatory disease, strep throat, pneumonia, acute otitis media (middle ear infections), and endocarditis. [5]
The US Food and Drug Administration has placed its most serious warning – a so-called black-box warning – on a drug used to relieve menopausal hot flashes.
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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 ...
(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 FDA issued a black box warning in September 2010, for tigecycline regarding an increased risk of death compared to other appropriate treatment. [26] [3] [28] As a result of increase in total death rate (cause is unknown) in individuals taking this drug, tigecycline is reserved for situations in which alternative treatment is not suitable.
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 ...