UMEM Educational Pearls

Title: New FDA warning for codeine and tramadol in kids

Keywords: analgesics, Ultram, (PubMed Search)

Posted: 4/28/2017 by Mimi Lu, MD
Click here to contact Mimi Lu, MD

Question

The FDA recently announced restrictions on the use of Tramadol and Codeine in children and breastfeeding mothers due to possible harm in infants. Essentially, codeine will now be contraindicated for the treatment of cough and/or pain, and tramadol contraindicated to treat pain for children under age 12 years. Tramadol will be also be contraindicated in children younger than 18 years for treatment of pain after tonssillectomy/ adenoidectomy.

These medicines carry serious risks, including slowed or difficulty breathing and death. These medicines also should be limited in some older children.

Additional warnings apply for children 12 to 18 years who are obese, have severe lung disease, or sleep apnea as they may increase the risk of serious breathing problems.

Please be aware of these new restrictions to protect the health and safety of our patients.

A summary statement from the American Hospital Association (AHA) is posted below.

Bottom line: Do not prescribe codeine or tramadol for cough or pain in children and breastfeeding moms.

Answer

A summary statement from the American Hospital Association (AHA) is posted below.

FDA RESTRICTS USE OF CODEINE AND TRAMADOL
MEDICINES IN CHILDREN, RECOMMENDS AGAINST USE IN BREASTFEEDING MOTHERS

The Issue:

The Food and Drug Administration (FDA) today announced that it is restricting the use of codeine and tramadol medicines in children, as well as 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 also should be limited in some older children.

The FDA is requiring several changes to the labels of all prescription medicines containing these drugs. These new actions further limit the use of these medicines beyond FDA's 2013 restriction of codeine use in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids. The agency is now adding:

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 is urging health care professionals and patients to report side effects involving codeine-and tramadol-containing medicines to the FDA MedWatch program, through its online form.