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Valproic acid has a black box warning for hepatotoxicity, pancreatitis, and fetal abnormalities. [4] There is evidence that valproic acid may cause premature growth plate ossification in children and adolescents, resulting in decreased height. [36] [37] [38] Valproic acid can also cause mydriasis, a dilation of the pupils. [39]
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 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 ...
The U.S. Food and Drug Administration requires that all atypical antipsychotics carry a black box warning that the medication has been associated with an increased risk of mortality in elderly patients. [46] In 2005, the FDA issued an advisory warning of an increased risk of death when atypical antipsychotics are used in dementia. [47]
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 ...
Anticonvulsants: Depakote and More Several anticonvulsants — medications used to treat and prevent epileptic seizures and conditions such as bipolar disorder — are associated with hair loss.
Dextropropoxyphene subsequently carried a black box warning in the U.S., stating: Propoxyphene should be used with extreme caution, if at all, in patients who have a history of substance/drug/alcohol abuse, depression with suicidal tendency, or who already take medications that cause drowsiness (e.g., antidepressants, muscle relaxants, pain ...
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]