FDA announces stricter labeling rules to keep codeine-based meds away from children

The Food and Drug Administration released a statement Thursday saying it will require changes to safety labels on prescription opioid cough and cold medicines that contain codeine or hydrocodone, citing the “serious risks” these medicines pose to children.

The new procedures required of manufacturers come in response to data and expert advice received by the FDA, according to a news release. The administration also addressed the growing epidemic of opioid addiction – which has legislators’ attention after the deaths of nearly 2,000 Californians in 2016.

“It’s become clear that the use of prescription, opioid-containing medicines to treat cough and cold in children comes with serious risks that don’t justify their use in this vulnerable population,” FDA Commissioner Scott Gottlieb says in the news release.

Last April, the FDA required that a contraindication – the administration’s strictest warning – be attached to prescription codeine and tramadol medicines. The contraindication warns not to give these products to children under 12 due to their faster metabolisms. The FDA’s safety announcement also recommended that breastfeeding women avoid the products, “due to possible harm to their infants.”

Though milder side effects include headaches and vomiting, opioids can cause potentially fatal breathing problems, especially in children, the FDA warns.

Previous warnings about opioids have failed to prevent all incidences of prescription to children. After a 2013 warning by the FDA not to give children codeine after tonsillectomy or adenoidectomy procedures, an American Academy of Pediatrics report in November 2017 found that about 5 percent of children were still being prescribed the drug.