Published: 19 December 2018
Revised: 8 January 2020
Safety Information
Monitoring Communication
Update -
Tramadol and opioid effects in breastfeeding babies
8 January 2020
Description
Update information
Original communication
Update Information
During the
period
(19 December 2018 to 30 November 2019), the
Centre for Adverse Reactions Monitoring (CARM) received one case
report where a neonate suffered weight decrease, feeding disorder
and somnolence while the breastfeeding mother was taking tramadol
(case report 132061). The baby was reported to have recovered.
The tramadol data sheets state that breastfeeding while taking tramadol is not recommended. Medsafe will continue to monitor this issue through routine pharmacovigilance. The balance of benefits and risks of harm for tramadol remains positive and no further action is required at this time.
Original Communication
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
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 ()
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
- Medsafe. 2017. Use of Tramadol During Breastfeeding 7 July 2017. URL: www.medsafe.govt.nz/safety/EWS/2017/UseOfTramadolDuringBreastfeeding.asp (accessed 20 September 2018).
