Published: 19 December 2018
Revised:  9 August 2019

Safety Information

Monitoring Communication

Medsafe emphasises that patients should NOT stop using any medicine or medical device subject to a monitoring communication. If you have any concerns with a medicine or medical device you are using, please contact your health professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

M2 Logo Tramadol and opioid effects in breastfeeding babies


9 August 2019

Description


Products affected
Additional information
Regulator actions
Reporting
References

Monitoring has been extended to finish on 30 November 2019.

Medsafe is highlighting the possible risk of opioid effects in breastfed babies whose mothers are prescribed tramadol following delivery. The aim is to encourage further reports and increase the information on this safety concern.

The Centre for Adverse Reactions Monitoring received a case report where a neonate suffered feeding disorder, somnolence (sleepiness), respiratory disorder and weight decrease while the breastfeeding mother was taking tramadol (case report 129102). The baby was reported to have recovered.

The Medicines Adverse Reactions Committee (MARC) discussed this case at its 175th meeting on 13 September 2018. The Committee recommended that Medsafe monitor for any opioid-like effects or withdrawal effects in babies exposed to tramadol in breast milk.

Products Affected

Product name Sponsor
Tramal Capsule, Solution for Injection, Sustained Release Tablet, Oral Drops Seqirus
Arrow – Tramadol Capsule Teva Pharma

Additional Information

In July 2017, Medsafe issued an alert communication about the use of tramadol during breastfeeding, based on information known at the time.

Small amounts of tramadol are found in breast milk and the effect this has on infants and newborns has not been studied1. 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 years1. 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 pain1. 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.

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

Regulator Actions

Medsafe is placing this safety concern on the Medicines Monitoring (M2 Logo) scheme to encourage reporting of possible opioid effects in the baby when breastfeeding mothers receive tramadol.

Reporting

Please report any events in breastfed babies whose mothers receive tramadol.

Medsafe will continue to monitor this issue and will produce updated advice for healthcare professionals and consumers as necessary.

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.

References

  1. Medsafe. 2017. Use of Tramadol During Breastfeeding 7 July 2017. URL: www.medsafe.govt.nz/safety/EWS/2017/UseOfTramadolDuringBreastfeeding.asp (accessed 20 September 2018).
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