FDA – Codeine and Tramadol in children and breastfeeding women

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

The Food and Drug Administration (FDA) is restricting the use of codeine and tramadol medicines in children. 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 should also be limited in some older children. Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults. We are also recommending against the use of codeine and tramadol medicines in breastfeeding mothers due to possible harm to their infants.

As a result, we are requiring several changes to the labels of all prescription medicines containing these drugs. These new actions further limit the use of these medicines beyond our 2013 restriction of codeine use in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids. We are 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.

More information available from the FDA website.

AnSafe Meeting Friday 21st April

(posted on behalf of Alison Herdman)

The next Ansafe Meeting will be held on the Friday after Easter which is April 21st.

The meeting will be held as usual at the Southport Anaesthetic Services HQ at Minnie St and will start at 6pm promptly.

If you have any agenda items for Pindara, GCPH, GCSH or any issue which is bothering you please email me directly, or;

  • For Pindara James Derrick
  • For GCPH Adrian Skidmore or Stuart Green
  • For the GCSH Phil Lo
  • JFH have their own Anaesthetic Meetings which are chaired by Di Sapwell but very often Pindara issues are Ramsay issues so items overlap. Andrew Cairncross is the Anaesthetic MAC representative at JFH

You can also submit agenda items online from the GCAPE AnSafe page.

Alison Herdman.