The Food and Drug Administration warned Thursday that children and adolescents should not be prescribed cough and cold medicines containing codeine and hydrocodone because of serious safety risks posed by the opioid ingredients.
The agency said it is requiring manufacturers to change the wording on their labels to make clear that such products should not be used for anyone younger than 18. Common side effects of opioids include headaches, dizziness and vomiting. Greater dangers include breathing difficulties and even death.
The FDA also said it is requiring manufacturers to add new safety warnings for adult use — including an expanded box warning, the most prominent kind — spelling out the risks of using medications with codeine and hydrocodone.
The warnings are consistent with the labels on other drug products with opioids, including painkillers.
Thursday's action expands a previous warning issued by the agency in April against the use of prescription medications containing codeine and tramadol for children younger than 12. At the time, officials expressed concerns that some children are “ultrarapid metabolizers” who process such drugs very quickly, resulting in dangerously high levels that can depress breathing and lead to death.
The new warning follows an extensive FDA review of data and a meeting of the agency's Pediatric Advisory Committee in September. The panel declared that the risks of using certain opioids in children’s cough medications outweigh the benefits.
According to the agency, outside experts said that while some children's coughs require treatment, many get better on their own — including ones that are the result of respiratory infections.
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. “At the same time, we’re taking steps to help reassure parents that treating the common cough and cold is possible without using opioid-containing products,” he said.
The agency urged parents to read the labels on prescription bottles. “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.