The FDA has issued a drug safety communication regarding new restrictions for the use of codeine and tramadol medications in children and nursing mothers.
According to the announcement, the FDA has issued labeling changes to help protect children from the serious risks associated with use. The updated changes include:
- A contraindication to the codeine and tramadol labels alerting users that codeine should not be used to treat pain or cough and tramadol should not be used to treat pain in children younger than 12 year sold.
- A new contraindication to the tramadol label warning against its use in children younger than 18 years old to treat pain after surgery to remove the tonsils and/or adenoids.
- A new warning to codeine and tramadol labels recommending against their use in adolescents between 12-18 years old who are obese and have conditions such as obstructive sleep apnea or severe lung disease.
- A strengthened warning to mothers that breastfeeding is not recommended when taking codeine or tramadol medicines due to the risk of serious adverse reactions in breastfed infants, which can include excess sleepiness, difficulty breastfeeding, or serious breathing problems that could result in death.
A review of medical literature for data regarding the use of codeine in nursing mothers found several cases of excess sleepiness and serious breathing problems in breastfed infants, including 1 reported death. No cases of adverse events were reported in a review of tramadol use in nursing mothers.
Additionally, the FDA reviewed adverse events reports submitted to the agency spanning from 1969 to 2015, and found 64 cases of serious breathing problems, including 24 deaths, associated with codeine-containing medicines in children younger than 18 years old. Nine cases, including 3 deaths, were identified with the use of tramadol.
FDA officials are also considering additional regulatory actions for over-the-counter codeine products, as well as an FDA Advisory Committee meeting to address the role of prescription opioid cough-and-cold medicines to treat cough in children.
FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women [news release]. FDA’s website. https://www.fda.gov/Drugs/DrugSafety/ucm549679.htm
. Accessed April 20, 2017.