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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 ...
An FDA warning letter is an official message from the United States Food and Drug Administration (FDA) to a manufacturer or other organization that has violated some rule in a federally regulated activity. The FDA defines an FDA warning letter as:
The drug is also used for narcolepsy.
The report published by the committee noted that while methadone itself was potentially addictive, it produced "considerably" less euphoria, sedation, and respiratory depression than morphine at equianalgesic doses and was thus interesting as a commercial drug. The same report also compared methadone to pethidine.
(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 Food and Drug Administration issued a new warning late Tuesday about supplements that contain the ingredient tianeptine, commonly known as "gas station heroin." The products — sold under the ...
The drug label has a black box warning that the drug may cause serious psychiatric and behavioral changes; it may cause homicidal or suicidal thoughts. [8] Other side effects have included dizziness, somnolence, vertigo, aggression, anger, loss of coordination , blurred vision, irritability, and slurred speech . [ 8 ]
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