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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 ...
Side effects are uncommon and typically mild, [1] and may include stomach pain, abdominal cramps or diarrhea, [1] Efficacy decreases with long-term use, and may cause poor bowel function. [9] Serious allergic reactions may occur with the drug. The most severe side effect of docusate, although very rare, is rectal bleeding. [23]
Escitalopram, sold under the brand names Lexapro and Cipralex, among others, is an antidepressant medication of the selective serotonin reuptake inhibitor (SSRI) class. [9] It is mainly used to treat major depressive disorder and generalized anxiety disorder. [9]
The United States Food and Drugs Administration is warning pet owners about a common medication given to pets to treat arthritis. The F.D.A. now says that the drug Librela may be associated with ...
All antidepressants, including Lexapro (escitalopram), carry a “black box” warning from the FDA that lists potentially serious side effects and provides important safety information about the ...
An earlier petition by Public Citizen in 2008 based on an analysis of 180 reports led to the FDA adding the current black box warning about the risk of Botox's effect spreading to other areas of ...
An auxiliary label (also called cautionary and advisory label or prescription drug warning label) is a label added on to a dispensed medication package by a pharmacist in addition to the usual prescription label. These labels are intended to provide supplementary information regarding the safe administration, use, and storage of the medication. [1]
The US label for sodium oxybate has a black box warning because it is a central nervous system depressant (CNS depressant) and for its potential for abuse.Other potential adverse side effects include respiratory depression, seizures, coma, and death, especially when it is taken in combination with other CNS depressants such as alcohol.