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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 ...
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.
Tetracycline, sold under various brand names, is an antibiotic in the tetracyclines family of medications, used to treat a number of infections, [3] ...
The black box, or boxed, warning refers to a prominent warning encased in a bold black border in the labeling or pamphlet of some medications. It’s meant to raise awareness of certain risks of ...
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 ...
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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. [35] [36]
Tetracyclines are generally used in the treatment of infections of the urinary tract, respiratory tract, and the intestines and are also used in the treatment of chlamydia, especially in patients allergic to β-lactams and macrolides; however, their use for these indications is less popular than it once was due to widespread development of resistance in the causative organisms.