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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.
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 ...
Montelukast is used for a number of conditions including asthma, exercise induced bronchospasm, allergic rhinitis, and urticaria. [11] It is mainly used as a complementary therapy in adults in addition to inhaled corticosteroids, if inhaled steroids alone do not bring the desired effect.
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In 2002 the United States Food and Drug Administration (FDA) obligated BMS to add a black box warning about potential fatal liver toxicity to the drug label. [ 43 ] [ 13 ] Worldwide sales in 2002 were $409 million.
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