Codeine, Tramadol Side Effects Too Dangerous For Children, FDA Rules

Federal regulators warn that children should not be prescribed certain opioid-based pain medications, including codeine and tramadol, due to the risk of severe injury or death. 

In a drug safety communication issued on April 20, the FDA outlines a strict stance against the use of both codeine and tramadol pain medications for children under the age of 18. The agency is limiting the use of the drugs among minors, and requiring changes to the warning labels for all products that contain the opioid medications.

Codeine is found in some prescription pain and cough medicines, as well as some over-the-counter medications for children. Tramadol is found in some prescription pain medications.

According to the FDA warning, some children will metabolize opioids much quicker, causing unusually high levels of the active form of the drug to reach their systems much faster. This can cause serious and life-threatening problems, including respiratory depression and death.

The new changes require a contraindication on the labels of both pain medications for use among children under 12. It also calls for strong warnings against the use of the two drugs among children between the ages of 12 to 18, who have certain medical conditions, such as obstructive sleep apnea, lung disease or other conditions that affect the breathing.

The labeling will also include a warning against the use of tramadol after a tonsillectomy or adenoidectomy, because it can also cause respiratory depression, endangering the child’s life.

The new regulations also recommend breastfeeding mothers refrain from using the drugs while nursing. In some cases, the drug can break down much quicker and the mother can pass it along to the child in the breast milk, causing respiratory depression in the unborn child.

Last year the American Academy of Pediatrics warned parents and doctors against giving children drugs with codeine. The medical group said children could suffer serious breathing problems, increasing their risk of death.

The FDA said they enacted the new warnings to ensure the safety of children who may use the medications for pain. Both drugs are only approved by the FDA for use in adults.

The agency encourages parents to review drug labeling ingredients, to ensure the medications do not include codeine or tramadol. Many over-the-counter medications also include these ingredients. Parents should always consult a doctor before using medications which contain either of the drugs in question.

“We understand that there are limited options when it comes to treating pain or cough in children, and that these changes may raise some questions for health care providers and parents,” wrote Douglas Throckmorton, M.D., deputy center director for regulatory programs, Center for Drug Evaluation and Research, in a press statement announcing the labeling changes. “However, please know that our decision today was made based on the latest evidence and with this goal in mind: keeping our kids safe.”

This isn’t the first time the FDA has regulated codeine for use in children. In 2013, the FDA issued a Boxed Warning and contraindications for prescription codeine use for children up to age 18. In 2015, the FDA issued another warning, indicating the use of medications containing codeine could cause severe respiratory problems in children.