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nsucurrent.com November 24, 2017


FDA strengthens warning against codeine and tramadol for children

22 April 2017, 01:40 | Violet Powell

FDA: No Codeine or Tramadol for Children Under 12 -- Period

FDA Updates Restrictions of Codeine and Tramadol Use in Children, Nursing Mothers

US regulators are strengthening warnings about the dangers of two types of powerful opioid painkillers, codeine and tramadol, due to risks of slowed breathing and death.

Finally, the FDA said that these drugs should not be used in children 12 to 18 who are obese, suffer from obstructive sleep apnea or have a weakened respiratory system, as they can increase the chances of risky breathing problems.

Additionally, the FDA recommended breastfeeding mothers not use codeine and tramadol medicines "due to possible harm to their infants". A new Contraindication is being added to the tramadol label warning against its use in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids.

"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."

Throckmorton said that the agency was both increasing restrictions on the products' labels and issuing a warning to consumers and pediatricians because of new information and concerns about the drugs' risks.

In the body, opioid painkillers and cough medicines are broken down into morphine.




Codeine and tramadol are opioid medications used to treat pain.

In its statement, the FDA has rounded up a list of codeine-containing drugs to watch out for - such as codeine sulfate, codeine phosphate, Butalbital, Acetaminopen, Tylenol, Promethazine, Prometh VC, Triacin-C, Tuxarin ER, and Tuzistra-XR. FDA has also identified nine cases of severe breathing problems, including three deaths, with the use of tramadol in children younger than 18 years from January 1969 to March 2016, it added. Apparently, narcotics such as codeine and tramadol can be fatal when used by children. However, please know that our decision today was made based on the latest evidence and with this goal in mind: "keeping our kids safe".

"These medicines should also be limited in some older children". Those infants can become too sleepy, have difficulty breastfeeding, or have serious breathing problems. If a codeine-or tramadol-containing product is determined to be appropriate for an adolescent patient, clinicians should provide counseling on how to recognize the signs of opioid toxicity.

Meanwhile, the FDA advises Clinicians to refer parents to seek over-the-counter products or possibly FDA-approved prescription medicines that are not fatal to kids under 12-years old. The FDA doesn't recommend OTC cold and cough medicines for children younger than 2.

Conclusively, parents should actively check for any warning labels on medication that they plan to give to their children.



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