The FDA will require label changes that limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone to adults aged 18 years and older. In addition, the agency will require added safety information highlighting the risks of misuse, abuse, addiction, overdose, death, and slowed or difficult breathing to the “boxed warning” on labels of these medicines.
The FDA advises healthcare professionals to reassure parents that cough due to a cold or upper respiratory tract infection is self-limited and generally does not need to be treated. For children in whom cough treatment is necessary, alternative medicines are available. These include over-the-counter products, such as dextromethorphan, as well as prescription benzonatate products.