FDA Commissioner Scott Gottlieb, who has made battling the opioid epidemic a top priority, said in a statement Thursday that it is critical "to protect children from unnecessary exposure" to prescription cough medicines containing codeine or hydrocodone.
The U.S. Food and Drug Administration will now require safety labeling changes to limit the use of prescription opioid cough and cold medicines. Instead, they will be labeled for use only in adults aged 18 and older.
The FDA also said it is requiring manufacturers to add new safety warnings for adult use - including an expanded boxed warning, the most prominent kind - spelling out the risks of using medications with codeine and hydrocodone. We know that any exposure to opioid drugs can lead to future addiction. Consider recommending over-the-counter (OTC) or other FDA-approved prescription medicines for cough and pain management in children younger than 12 years and in adolescents younger than 18 years, especially those with certain genetic factors, obesity, or obstructive sleep apnea and other breathing problems. Previous year the restrictions were expanded to include safety labels that carried the contraindication warning, the FDA's most severe warning, to say that it should not be used for patients under the age of 12.
Do you reach for the cough syrup when your little one catches a cold?
Common side effects of opioids include drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache. Moreover, the risks of using prescription opioid cough products in children of all ages generally outweigh the potential benefits. Experts and pediatricians advised that while coughs in those under 18 sometimes do require treatment, usually the coughs were caused by a cold or upper respiratory infection; the risks of the opioid medication would outweigh benefits.
"The opioid epidemic has many origins, but can begin with exposure to [opioids] at young ages", he said. "If the medicine prescribed for your child contains an opioid, talk to your child's health care professional about a different, non-opioid medicine", it said. For those children in whom cough treatment is necessary, alternative medicines are available.
Parents whose children are now prescribed cold or cough medication containing codeine or hydrocodone are encouraged to talk with their doctors about other treatment options.
Caregivers and patients should always read the label on prescription bottles to find out if a medicine contains codeine or tramadol.