FDA recommends against use of codeine, tramadol in breastfeeding women, younger children

Medicines containing codeine and tramadol should not be used in breastfeeding mothers or children younger than 12 years and should be limited in some older children, according to a press release issued by the FDA.

Codeine and tramadol may increase the risk for serious adverse reactions in infants of breastfeeding women, including excess sleepiness, difficulty breastfeeding or serious breathing issues that may result in death. In addition, these drugs pose serious health effects in children, such as slowed or difficult breathing and death, with children aged 12 years or younger at the greatest risk.

Tramadol and single-ingredient codeine products are only approved by the FDA for use in adults.

The FDA is now requiring several changes to prescription medications containing codeine and tramadol, including the addition of a contraindication warning to drug labels to alert consumers that codeine should not be used to treat pain or cough; tramadol should not be used to treat pain in children younger than 12 years; and tramadol should not be used for pain after the surgical removal of tonsils and/or adenoids in children younger than 18 years. The FDA will also add a new warning to drug labels recommending against the use of codeine and tramadol in adolescents aged 12 to 18 years with obesity or conditions that may heighten the risk for serious breathing problems, such as obstructive sleep apnea or severe lung disease. Furthermore, the FDA will include a strengthened warning for breastfeeding mothers against the use of codeine or tramadol due to the increased risk of serious adverse reactions in infants.