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Safety Information

Trans-Tasman Early Warning System - Alert Communication

Use of tramadol during breastfeeding

7 July 2017

Products Affected
Information for consumers and caregivers
Information for healthcare professionals
Data Summary
What actions are Medsafe taking?
How to report adverse events
Further information

Small amounts of tramadol are found in breast milk and the effect this has on infants and newborns is not fully known. Therefore, the tramadol data sheets state that breastfeeding while taking tramadol is not recommended. 

Tramadol is used for the relief of moderate to severe pain in adults and children from the age of two years. It is sometimes used to help manage pain after a caesarean section.

Tramadol is changed in the body to another substance (active metabolite), which also helps with pain. Small amounts of tramadol and its metabolite are found in breast milk when taken by the mother. The amounts of tramadol and its metabolite are usually too low to cause a problem for the baby. However, there is a risk that the baby’s breathing may be affected or that the baby may be allergic to tramadol or its metabolite.

Products Affected

Product name Sponsor
Arrow - Tramadol Capsule Teva Pharma
Durotram XR Modified release tablet iNova Pharmaceuticals
Tramadol Hydrochloride Capsule AFT Pharmaceuticals
Tramal Capsule, SR Modified release tablet, Solution for injection, Oral Solution Seqirus

 

Information for consumers and caregivers

  • Small amounts of tramadol are found in breast milk and the effect this has on infants and newborns is not fully known.
  • Your specialist doctor (obstetrician), midwife or general practitioner (GP) may prescribe tramadol for you whilst you are breastfeeding. They will have considered the benefits and risks of harm to you and your baby and decided this is the right medicine for you. They will discuss and explain this to you.
  • Tramadol is sometimes used to help manage pain after a caesarean section.
  • Watch your baby closely for signs of breathing problems if you are taking tramadol and breastfeeding. These signs include slow or shallow breathing, difficulty or noisy breathing, more than usual sleepiness, trouble breastfeeding or limpness.
  • Seek immediate medical attention if you notice your baby is having trouble breathing or are worried about your baby.
  • Breast milk is the perfect food for your baby and breastfeeding is perfect for you too.
  • If you have any questions, talk to your specialist doctor (obstetrician), midwife, general practitioner (GP) or pharmacist.

 

Information for healthcare professionals

  • The use of tramadol during breastfeeding is not recommended because its safety in infants and newborns has not been studied.
  • The benefits and risks of harm of treatment with tramadol in both the mother and baby should be considered as well as the benefits and risks of harm of not treating.
  • It is also important to consider the benefits and risks of harm of using an alternative analgesic. Non-steroidal anti-inflammatory drugs (NSAIDs) may not be suitable for some women. Women who are ultra-rapid metabolisers of codeine may have higher morphine levels in their breast milk, which may lead to life-threatening or fatal side effects in newborns. Oxycodone may cause respiratory depression in newborns. Consult the data sheets for more information.
  • Discuss with your patient the benefits and risks of harm of using tramadol during breastfeeding.
  • The exposure of the baby to tramadol is low at around 112 microgram/kg/day (2.24% relative to the mother) and around 30 microgram/kg/day (0.64% relative to the mother) for the active metabolite when the mother is taking tramadol 100 mg orally every six hours.
  • Exposure is likely to be greater the longer the mother takes tramadol since bioavailability increases over time. Advise parents and caregivers to watch closely for signs of breathing problems in infants and newborns exposed to tramadol through breast milk. These signs include slow or shallow breathing, difficulty or noisy breathing, more than usual sleepiness, trouble breastfeeding or limpness.

Data Summary

The United States Food and Drug Administration (FDA) recently published a drug safety communication recommending against the use of tramadol during breastfeeding. In New Zealand, the Medicines Adverse Reactions Committee (MARC) reviewed the use of tramadol in children in June 2016.

The recommended dose of tramadol in adults is 50–100 mg every four to six hours up to a maximum of 400 mg/day [1, 2].

The recommended dose of tramadol in children between the ages of 2 and 12 is 1–2 mg/kg up to a maximum daily dose of the lesser of 8 mg/kg/day or 400 mg/day [1, 2].

Tramadol is rapidly and almost completely absorbed after taking a 50 mg oral dose. The average absolute bioavailability (proportion of a medicine that enters the circulation) is 68–72% after a single oral dose of 100 mg and increases to more than 90% after repeated oral doses[1, 2].

After entering the circulation, very small amounts of tramadol and its active metabolite are found in breast milk (0.1% and 0.02%, respectively, of the administered dose) 1, 2]. A trial involving 75 breastfeeding mothers taking oral tramadol 100 mg every six hours following caesarean section evaluated the transfer of tramadol and its active metabolite into transitional milk at day 2–4 post surgery. The estimated absolute and relative infant doses were 112 microgram/kg/day (2.24%) and 30 microgram/kg/day (0.64%) for tramadol and the active metabolite, respectively  [3]

Although very small amounts of tramadol and its active metabolite are found in breast milk, its safety in newborns and infants has not been studied. There is a theoretical risk of breathing problems in the baby due to the opioid effects of tramadol. The Centre for Adverse Reactions Monitoring (CARM) has received one case report in a one-month-old where exposure to tramadol via breast milk was suspected to have caused a red rash. The mother had taken 25–50 mg of tramadol for a migraine and then breast fed. Approximately one hour later, she noticed a red rash on the baby. The baby was reported to have recovered and the rash was not considered severe or serious.

What actions are Medsafe taking?

Medsafe continues to monitor the safety of tramadol.

Medsafe cannot give advice about an individual’s medical condition. If you have any concerns about a medicine you are taking, Medsafe encourages you to talk to your healthcare professional.

How to report adverse events

Phone + 64 3 479 7247 to speak to a Medical Assessor at the Centre for Adverse Reactions Monitoring (CARM)
  From your iPhone using the ADR online app
Online Submit a report to CARM
Prescribers can submit using the online reporting tool available in patient management software
Yellow Card A completed Yellow card can be submitted to CARM via email, fax or mail
Email carmnz@otago.ac.nz
Fax +64 3 479 7150


Further information

Advice on how to take tramadol and known side effects can be found in the consumer medicine information (CMI) and data sheets.

Search for consumer medicine information and data sheets

United States Food and Drug Administration (FDA) drug safety communication

Medicines Adverse Reactions Committee (MARC) review on use of tramadol in children

References

  1. Teva Pharma (New Zealand) Limited. Arrow - Tramadol 50 mg Capsules New Zealand Data Sheet. 21 March 2017 [Accessed 16 May 2017]; Available from: www.medsafe.govt.nz/profs/Datasheet/a/arrowtramadolcap.pdf.
  2. Seqirus (NZ) Ltd. Tramal New Zealand Data Sheet. 29 March 2017 [Accessed 7 June 2017]; Available from: www.medsafe.govt.nz/profs/Datasheet/t/TramalcapSRtabinjoraldrops.pdf.
  3. Ilett, K.F., et al., Use of a sparse sampling study design to assess transfer of tramadol and its O-desmethyl metabolite into transitional breast milk. Br J Clin Pharmacol, 2008. 65(5): p. 661-6.
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