PhotoThere's a lot of concern about opioid abuse by adults, but the Food and Drug Administration (FDA) says there are also serious risks associated with giving opioids to children.

The agency said today that it is changing the labeling requirements for two types of opioid medications often given to children -- codeine, found in some prescription pain and cough medicines and some over-the-counter cough medicines, and tramadol, found in some prescription pain medicines.

"We are requiring these changes because we know that some children who received codeine or tramadol have experienced life-threatening respiratory depression and death because they metabolize these medicines much faster than usual, causing dangerously high levels of active drug in their bodies," said the FDA's Douglas Throckmorton, M.D.

"This is especially concerning in children under 12 years of age and adolescents who are obese or have conditions that may increase the risk of breathing problems, like obstructive sleep apnea or lung disease," Throckmorton said. Respiratory depression can also occur in nursing babies, when mothers who are ultra-rapid metabolizers take these types of medicines and pass it along to their children through their breast milk, he said.

Additional warnings

Throckmorton noted that since 2013, prescription codeine labeling has contained a Boxed Warning and Contraindication for children up to age 18 years of age regarding the risk of life-threatening respiratory depression following the use of codeine for pain management after the removal of the tonsils (tonsillectomy) and/or adenoids (adenoidectomy).

Now, labels for both codeine and tramadol are being updated to include additional Contraindications and Warnings; among the updates are Contraindications for use of codeine or tramadol in all children younger than 12 years of age, warnings about their use in children 12-18 years of age with certain medical conditions, and a stronger warning recommending against their use in nursing mothers.

In addition to these labeling changes, labeling for tramadol-containing products will also get a Contraindication for post-operative pain management in children up to age 18 years of age who have undergone tonsillectomy and/or adenoidectomy, which is already in labeling for codeine products.

"We urge health care providers, stakeholders and the public to read the Drug Safety Communication that we issued today, which provides more detailed information," Throckmorton added. "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. However, please know that our decision today was made based on the latest evidence and with this goal in mind: keeping our kids safe."


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