The Food and Drug Administration (FDA) has issued a warning about the use of prescription codeine and tramadol medications in children.
According to a health alert, children younger than 12 should never take the medications.
FDA: Don’t give kids prescriptions containing codeine
Codeine is approved to treat pain and cough, and tramadol is approved to treat pain. The FDA says the medications carry serious risks, including slowed or difficult breathing and even death.
The FDA is also recommending that breastfeeding mothers avoid using these medicines.
Since 2013, drugs containing codeine already contain a boxed warning that cautions against children using the medicine to treat pain after surgery to remove tonsils.
Now, the FDA is adding several additional changes to the labels of these prescription medications:
• FDA’s strongest warning, called a Contraindication, to the drug labels of codeine and tramadol alerting 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 years.
• A new Contraindication 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.
• A new Warning to the drug labels of codeine and tramadol to recommend against their use in adolescents between 12 and 18 years who are obese or have conditions such as obstructive sleep apnea or severe lung disease, which may increase the risk of serious breathing problems.
• 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. These can include excess sleepiness, difficulty breastfeeding, or serious breathing problems that could result in death.
The FDA reminds parents and caregivers to always read the labels on prescription bottles to find out if a medicine contains codeine or tramadol.
Tramadol and single-ingredient codeine medicines are still FDA-approved for use in adults.
Prescription codeine and tramadol pain and cough medicines
The FDA says health care professionals should recommend over-the-counter or other FDA-approved prescription medicines for cough and pain management in children.
The agency is considering additional action for OTC codeine products that are available in some states.