FDA Drug Safety Communication on codeine pain and cough medicines and tramadol pain medicines
FDA is restricting the use of codeine and tramadol medicines in children. We are also recommending against using codeine and tramadol medicines in breastfeeding mothers due to possible harm to their infants.
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.
As a result, we are requiring several changes to the labels of all prescription medicines containing these drugs. These new actions further limit the use of these medicines beyond our 2013 restriction of codeine use in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids.