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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 ...
Quinolone antibiotics constitute a large group of broad-spectrum bacteriocidals that share a bicyclic core structure related to the substance 4-quinolone. [1] They are used in human and veterinary medicine to treat bacterial infections , as well as in animal husbandry, specifically poultry production.
Prominent among these are adverse effects that became the subject of a black box warning by the FDA in 2016. [9] The FDA wrote: "An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious adverse effects that can occur together.
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 ...
Amoxicillin is an antibiotic that’s used to treat bacterial infections like pneumonia, bronchitis, and infections of the ears, nose, throat, urinary tract, and skin, according to Medline Plus ...
Similarly, the Canadian label includes a warning of the risk of liver injury. [54] The U.S. label does not contain restrictions similar to the European label, but a carries a "black box" warning of the risk of tendon damage and/or rupture and warnings regarding the risk of irreversible peripheral neuropathy. [55]
In addition, the FDA worked with the manufacturer to update the product labeling with a "black box warning," their strongest form of warning. Ketek's warning states that it should not be used in patients with myasthenia gravis , a disease that causes muscle weakness. [ 15 ]
Other antibiotics, such as chloramphenicol or amoxicillin may also be used. [21] Chloramphenicol is used successfully in many parts of the world, but contains a black box warning in the United States due to concerns about aplastic anemia , which on rare occasions can be fatal.