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While most cases of coughing up blood in children are mild and self-limited, there is a risk of potentially life-threatening hemoptysis related to arteriovenous malformations, pulmonary vascular anomalies, congenital heart disease (for example, valvular heart disease such as mitral stenosis)

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"This authorization is a departure from FDA's longstanding recognition in its review of these products that flavors pose significant risks to youth, setting a concerning precedent and leaving pediatricians deeply alarmed that these products will end up in the hands of young people," said American Academy of Pediatrics President Dr

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