FDA: Do Not Use Codeine, Tramadol in Children

The FDA is adding the following new restrictions to the warning labels of codeine and tramadol (an opiod pain medication sold under the brandname of Ultram):

  • Codeine is contraindicated to treat pain or cough, and tramadol is contraindicated for treating pain in children under 12.
  • Tramadol is contraindicated for treating pain after surgery to remove tonsils and/or adenoids for children under 18. Use of codeine for this purpose was placed under the same restriction in 2013.
  • Codeine and tramadol are not recommended for use in adolescents ages 12-18 who are obese or have conditions such as obstructive sleep apnea or severe lung disease.
  • Mothers should not breastfeed when taking codeine or tramadol.


The FDA gave its recommendation on 4/20/17. The following is taken from an FDA communication found at https://www.fda.gov/Drugs/DrugSafety/ucm549679.htm :


Codeine and tramadol are a type of narcotic medicine called an opioid. Codeine is used to treat mild to moderate pain and also to reduce coughing. It is usually combined with other medicines, such as acetaminophen, in prescription pain medicines. It is frequently combined with other drugs in prescription and over-the-counter (OTC) cough and cold medicines. Tramadol is a prescription medicine approved only for use in adults to treat moderate to moderately severe pain. However, data show it is being used in children and adolescents despite the fact that it is not approved for use in these patients.

In early 2013, FDA added a Boxed Warning to the codeine drug label cautioning against prescribing codeine to children of any age to treat pain after surgery to remove tonsils or adenoids. We also issued Drug Safety Communications in July 2015 and September 2015 warning about the risk of serious breathing problems in some children who metabolized codeine and tramadol much faster to their active form than usual (called ultra-rapid metabolism), causing potentially dangerously high levels in their bodies too quickly. At that time, we said we would continue to evaluate this safety issue. As part of that safety review, the codeine-related safety issues were discussed at an FDA Advisory Committee meeting in December 2015.

Our review of several decades of adverse event reports submitted to FDA* from January 1969 to May 2015 identified 64 cases of serious breathing problems, including 24 deaths, with codeine-containing medicines in children younger than 18 years. This includes only reports submitted to FDA, so there may be additional cases about which we are unaware. We also identified nine cases of serious breathing problems, including three deaths, with the use of tramadol in children younger than 18 years from January 1969 to March 2016 (see Data Summary). The majority of serious side effects with both codeine and tramadol occurred in children younger than 12 years, and some cases occurred after a single dose of the medicine.

In our review of the medical literature1-19 for data regarding codeine use during breastfeeding, we found numerous cases of excess sleepiness and serious breathing problems in breastfed infants, including one death. A review of the available medical literature4,5,23,24 for data regarding tramadol use during breastfeeding did not reveal any cases of adverse events. However, tramadol and its active form are also present in breast milk, and tramadol has the same risks associated with ultra-rapid metabolism as codeine.

Una respuesta a “FDA: Do Not Use Codeine, Tramadol in Children

  1. A sound move! Given how common the «ultra rapid metabolizer» genotypes are (1-2% of the population in the US) this is especially true. https://www.ncbi.nlm.nih.gov/books/NBK100662/
    Honestly, having known more than one person who has had severe adverse reactions to prescribed opioid based medicinies, I am surprised that these drugs are prescribed at all, to anyone, without CYP2D6 activity testing. CYP2D6 is an enzyme that is made by the liver, and that is responsible for metabolizing approximately 25% of all the drugs that are prescribed by doctors, including opioids. It is an enzyme that is responsible for turning codeine into the active ingredient of morphine, and tramadol, which is a weak mu opioid receptor agonist, into the much stronger O-desmethyltramadol. So while tramadol is often considered a safer form of opioids, for a high metabolizer, it can lead to adverse effects. Why are CYP2D6 genotypes not determined for every patient, regardless of age? Are we not in 2017? In addition to high metabolizers, another big proportion of the population metabolizes opioids more slowly than the rest of the population.
    It really hurts to see your child in pain from surgery. Watching my five year old refuse to eat, or drink, after her adenectomy/tonsillectomy, and watching her be in so much pain was distressing. However, we called the on call doctor and he prescribed oral steroids to reduce swelling, in addition to the NSAIDs she was already taking, and that helped her get over the worst of it. Maybe there are situations were exceptions can be made for children with painful chronic illnesses, or serious injuries, but I fully support more caution for «routine» uses such as controlling a bad cough, or post op treatments. Especially when parents are sent home to administer dosages, as opposed to in hospital treatment with monitoring and trained professionals giving the pain meds.

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