Products covered by Thursday's announcement included four with codeine, in combination with other agents such as chorpheniramine and promethazine, and five with hydrocodone along with other ingredients.
Officials with the FDA have announced labeling changes to prescription opioid cough and cold medications that contain codeine or hydrocodone.
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The revised safety warnings on these products will be consistent with the labeling of other opioid-containing drug products, such as immediate-release opioid analgesics and extended-release and long-acting opioid analgesics, according to the FDA.
FDA Commissioner Scott Gottlieb, MD, expressed concern for young children's unnecessary exposure to opioids in a statement. Notably, the FDA advisory committees that have been responsible for assessing the suitability of utilizing opioids as treatment options for coughs and colds in pediatric populations have focused on two age groups: those 6 to 12, and those 12 to 18. The contraindication - FDA's strongest warning - alerted patients that codeine should not be used to treat pain or cough in children younger than 12 years old, due to ultra-rapid metabolism being reported in patients.
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In 2015, the FDA also announced an investigation into the possible risks of using codeine-containing medicines to treat coughs and colds in children under 18.
The FDA also recommended against the use of these medications by women who are breastfeeding. Experts noted that most pediatric cough symptoms that are caused by a cold or upper respiratory do not typically require treatment with these products.
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The affected products are sold by certain generic drug makers.