FDA Warns Against Using Codeine and Tramadol in Children

According to an FDA Safety Announcement released 4/20/17, "The Food and Drug Administration (FDA) is restricting the use of codeine and tramadol medicines in children. Codeine is approved to treat pain and cough, and tramadol is approved to treat pain. These medicines carry serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used in these children. These medicines should also be limited in some older children. Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults. We are also recommending against the use of codeine and tramadol medicines in breastfeeding mothers due to possible harm to their infants."

The FDA is adding the following new restrictions to the warning labels of codeine and tramadol:

  • Codeine is contraindicated to treat pain or cough, and tramadol is contraindicated for treating pain in children under 12.
  • Tramadol is contraindicated for treating pain after surgery to remove tonsils and/or adenoids for children under 18. Use of codeine for this purpose was placed under the same restriction in 2013.
  • Codeine and tramadol are not recommended for use in adolescents ages 12-18 who are obese or have conditions such as obstructive sleep apnea or severe lung disease.
  • Mothers should not breastfeed when taking codeine or tramadol.

According to an AAP news article, "Since 1969, codeine has been linked to 64 cases of serious breathing problems, including 24 deaths in children and adolescents. Tramadol is not approved for pediatric use but has been tied to nine cases of serious breathing problems, including three deaths in children and adolescents, according to the FDA. There also have been cases of breathing problems in breastfed infants whose mothers were taking codeine."

Click here to read the full FDA drug safety communication.

Click here for a statement by Douglas Throckmorton, M.D., deputy center director for regulatory programs in the FDA's Center for Drug Evaluation and Research.

Click here to read the article in AAP News.