FDA warns against giving kids cough and cold medicines with codeine or hydrocodone

THE Food and Drug Administration warned 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 headache, dizziness and vomiting. Greater dangers include breathing difficulties and even death.

Thursday’s action expands a previous warning, issued by the agency last 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.

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 opioidcontaining 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.