The FDA is requiring change to the labeling of two types of opioid medications — codeine and tramadol — to protect children from the serious risk the medicines pose. Codeine is found in some prescription pain and cough medicines and some over-the-counter cough medicines, and tramadol is 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 (or break down) these medicines much faster than usual (called ultra-rapid metabolism), 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.
“This isn’t the first time we have taken action on codeine to better ensure the safety of our children.” Throckmorton said. “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.
Throckmorton said health care providers and consumers should read the Drug Safety Communication being issued by the FDA tody.