The FDA took more steps Thursday to keep opioids out of children’s medications, announcing changes to labels for nine types of prescription cough and cold medications containing codeine or hydrocodone, indicating that they should not be given to patients younger than 18.
Furthermore, labeling for these products will now include an expanded Boxed Warning, explaining “the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing” that can result — even in adults.
Thursday’s move expands on actions taken in April 2017, when the agency strengthened its warning on products containing codeine or tramadol for the treatment of cough and pain, adding a contraindication for children under the age of 12. 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 new announcement means the restrictions now encompass both groups.
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. The upshot: “Although some pediatric cough symptoms do require treatment, cough due to a cold or upper respiratory infection typically does not require treatment. Moreover, the risks of using prescription opioid cough products in children of all ages generally outweigh the potential benefits,” the FDA said in announcing the new labeling.
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. Brand names include Tuxarin ER, Tuzistra XR, Triacin C, FlowTuss, Rezira, and others. Some are available only in generic form.