Obstetric Anaesthesia SIG Tramadol Statement

Obstetric Anaesthesia SIG statement regarding the use of Tramadol in breastfeeding women


July 2017

On June 15, 2017, the Society of Paediatric Anaesthesia in Australia and New Zealand (SPANZA) released an “Advisory on Tramadol - Use of”.  The advisory can be found on their website here. This advisory was made in response to a drug safety communication made by the FDA here on the April 20, 2017 that recommended against the use of codeine and tramadol medicines in breastfeeding mothers due to possible harm to their infants. Subsequently, on July 7, 2017 (after consultation with ANZCA), MEDSAFE (the New Zealand Medicines and Medical Devices Safety Authority) published an “Alert Communication” on the use of tramadol during breastfeeding here.

 

The Obstetric Anaesthesia (OA) Special Interest Group supports the comprehensive document produced by SPANZA. The OA Special Interest Group does not support restricting the use of tramadol in breastfeeding women and would like to add the following information for anaesthetists providing obstetric anaesthesia services in Australia and New Zealand:

  • Effective analgesia for breastfeeding women is required after caesarean delivery, to facilitate mobility and early recovery from surgery. Breastfeeding women may also require analgesia for moderate to severe pain, after non-obstetric surgery. Current evidence-based analgesia recommendations for post-caesarean section pain relief advocate an opioid-sparing analgesic plan to reduce the dose requirement of strong opioid-based analgesics. For post-caesarean pain relief, analgesics such as tramadol are usually required for short periods only (48-72 hours).

  • Tramadol has a long history of safe widespread national and international use in women following caesarean section with over half a million women in Australia and New Zealand undergoing this operation in the last five years. Tramadol has been demonstrated to be an effective analgesic after caesarean section. It is one of the key components of multimodal analgesia, used in parenteral (IV) and oral forms, and is therefore widely used in breast feeding women.

  • The Pregnancy and Breastfeeding Medicines Guide (PBMG) from the Department of Health and Human Services (Victoria), states that the small amounts of tramadol and its active metabolite that are found in breast milk are unlikely to pose harmful effects to breastfed infants. Tramadol is considered safe to use at the lowest effective doses for the shortest duration possible during breastfeeding. The usual precautions regarding dose reduction in renal impairment should be followed.

  • Restrictions on the use of tramadol in breastfeeding women postpartum may have serious safety implications for the neonate, due to a resultant increase in the use of other opioid-based medications, for effective pain relief after caesarean section.

 

References

1.  Acute Pain Management Scientific Evidence 4th Edition, ed. S.A. Schug, et al. 2015, Melbourne: FPM and ANZCA.
2.  Australian Institute of Health and Welfare 2016. Australia’s mothers and babies 2014—in brief. Perinatal statistics series no. 32. Cat no. PER 87. Canberra: AIHW.
3. New Zealand Government Ministry of Health. Report on Maternity 2014.  Accessed July 10, 2017 at: http://www.health.govt.nz/publication/report-maternity-2014
4. Wilder-Smith, C.H., Hill, L., Dyer, R.A., Torr, G. and Coetzee, E., 2003. Postoperative sensitization and pain after cesarean delivery and the effects of single IM doses of tramadol and diclofenac alone and in combination. Anesthesia and Analgesia; 97(2): 526-533.
5. Department of Health and Human Services (Victoria).  Pregnancy and Breastfeeding Medicines Guide. Accessed July 3, 2017 website.
 
This document has been prepared in good faith and having regard to general circumstances and is intended for information only.  It is entirely the responsibility of the practitioner as to the manner in which s/he follows this document, having express regard to the circumstances of each case, and in the application of this document in each case.
 
The information contained in this document is not intended to constitute specific medical or other professional advice. The College and Societies, their officers and employees, take no responsibility in relation to the application of use of this document in any particular circumstance.
 
While the Obstetric Anaesthesia SIG endeavours to ensure that resource documents and statements are as current as possible at the time of their preparation, it takes no responsibility for matters arising from changed circumstances or information or material which may have become available subsequently.
 

Promulgated:2017

Date of current document: 2017

 
© This document is copyright; if it is reproduced in whole or in part, due acknowledgement is to be given.

 

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