"These include over-the-counter (OTC) products such as dextromethorphan, as well as prescription benzonatate products", the safety communication said. The makers of these medicines also will need to update their labeling to provide safety warnings consistent with the labeling of other opioid-containing drugs, and will feature an expanded Boxed Warning for adult use.
The label change also proceeds a pediatric restriction set previous year that required a contraindication to prescription codeine product labels.
The FDA said it conducted extensive reviews of available data and sought expert advice on opioid use in the treatment of childhood pain and cough.Читайте также: T25-Rutgers-Michigan St, 1st Ld-Writethru,429
"The U.S. Food and Drug Administration is requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older because the risks of these medicines outweigh their benefits in children younger than 18", it said in a statement. "At the same time we're taking steps to help reassure parents that treating the common cough and cold is possible without using opioid-containing products", he said. Common side effects of opioids include headache, dizziness and vomiting.
The move comes after a 2017 decision by the FDA to add its strongest warning - a "contraindication" - to labeling for prescription products containing codeine. According to the FDA, they should talk to their child's doctor about alternative therapies. Experts say parents should always read labels before giving their children any medicine, even if it's purchased over the counter.
The agency said it is requiring manufacturers to change the wording on their labels to make clear that such products should not be used for anyone younger than 18.При любом использовании материалов сайта и дочерних проектов, гиперссылка на обязательна.
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