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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 ...
Zafirlukast is FDA-approved for the prevention and treatment of asthma in adults and children older than 5 years old. [1] Like other leukotriene receptor antagonists, zafirlukast is thought to be useful for the long-term treatment of asthma, but it is generally less effective than inhaled glucocorticoids as monotherapy (which are the standard of care) or long-acting beta-2 agonists in ...
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.
Postmarketing surveillance has revealed a variety of relatively rare but serious adverse effects associated with all members of the fluoroquinolone antibacterial class. Among these, tendon problems and exacerbation of the symptoms of the neurological disorder myasthenia gravis are the subject of "black box" warnings in the United States. [36] [37]
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 ...
Ozempic carries a black box warning from the FDA (the FDA’s most serious warning). It says that semaglutide has caused thyroid C-cell tumors in rodents after long-term and high dose exposure to ...
Ciprofloxacin is a fluoroquinolone antibiotic used to treat a number of bacterial infections. [5] This includes bone and joint infections, intra-abdominal infections, certain types of infectious diarrhea, respiratory tract infections, skin infections, typhoid fever, and urinary tract infections, among others. [5]
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