Is Paracetamol compatible with breastfeeding? Do we have alternatives for Paracetamol?

Paracetamol

June 10, 2018 (Very Low Risk)

Analgesic and antipyretic. Indicated in the treatment of pain and fever. It has a weak anti-inflammatory effect.
Oral, intravenous and rectal administration, every 4, 6 or 8 hours.

Despite unfavorable pharmacokinetic data, it is excreted in very small quantities in breast milk (AEMPS 2017, GSK 2015, Notarianni 1987, Bitzén 1981, Findlay 1981, Berlin 1980, Hurden 1980).

The amount that the infant can receive through breast milk is much lower than the usual pediatric dose (Lee 1993).

No problems have been observed in infants whose mothers were taking it (AEMPS 2017, Ito 1993), except for one case of mild dermatitis in an infant (Matheson 1985).

The urinary levels of infants have been undetectable (AEMPS 2017, Berlin 1980).
Other authors have measured insignificant levels in urine, but only paracetamol, not their metabolites as in adults (Notarianni 1987).
The hepatotoxicity of paracetamol is lower in newborns and small infants due to hepatic immaturity: the low levels of specific cytochrome P-450 enzymes hinder the conversion of the drug into its toxic metabolites (Reece 2017, Sachs 2013).

Medication commonly used in Pediatrics, with authorized use in neonates, including premature infants.

American Academy of Pediatrics: medication usually compatible with breastfeeding (AAP 2001).
List of essential medicines WHO: compatible with breastfeeding (WHO / UNICEF, 2002).

The manufacturer (AEMPS 2017, GSK 2015) and expert authors and medical associations consider it compatible with breastfeeding (Reece 2017, Davanzo 2014, Rowe 2013, Worthington 2013, Sachs 2013, Amir 2011, Zrour 2010, Chen 2010, Østensen 2007, Bannwarth 2003, Bar-Oz 2003, Janssen 2000, Nice 2000, Spigset 2000, Mitchell 1999, Bodley 1997, Lee 1993, Bitzen 1981, Berlin 1980).

Alternatives

We do not have alternatives for Paracetamol since it is relatively safe.

Very Low Risk

Compatible. Not risky for breastfeeding or infant.

Low Risk

Moderately safe. Mild risk possible. Follow up recommended. Read the Comment.

High Risk

Poorly safe. Evaluate carefully. Use a safer alternative. Read the Comment.

Very High Risk

Not recommended. Cessation of breastfeeding or alternative.

Synonyms

  • Acetaminophen
  • N-Acetyl-P-Aminophenol

Writings

  • Παρακεταμόλη (Greek)
  • باراسيتامول (Arabic)
  • Парацетамол (Cyrillic)
  • 对乙酰氨基酚 (Chinese)
  • アセトアミノフェン (Japanese)
  • Paracétamol (French)
  • C8 H9 NO2 (Molecular formula)
  • 4′-Hydroxyacetanilide; N-(4-Hydroxyphenyl)acetamide (Chemical name)
  • N02BE01 (ATC Code/s)

Drug trade names

References

  1. Reece-Stremtan Sarah, Campos Matilde, Kokajko Lauren, and The Academy of Breastfeeding Medicine. Breastfeeding Medicine. ABM Clinical Protocol #15: Analgesia and Anesthesia for the Breastfeeding Mother, Revised 2017. Breastfeeding Medicine. 2017 Full text (link to original source) Full text (in our servers)
  2. AEMPS. Paracetamol. Ficha técnica. 2017 Full text (in our servers)
  3. GSK. Paracetamol (Panadol). Drug Summary. 2015 Full text (in our servers)
  4. Davanzo R, Bua J, Paloni G, Facchina G. Breastfeeding and migraine drugs. Eur J Clin Pharmacol. 2014Abstract
  5. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. 2013Abstract
  6. Athavale MA, Maitra A, Patel S, Bhate VR, Toddywalla VS. Development of an in vitro cell culture model to study milk to plasma ratios of therapeutic drugs. Indian J Pharmacol. 2013Abstract Full text (link to original source) Full text (in our servers)
  7. Worthington I, Pringsheim T, Gawel MJ, Gladstone J, Cooper P, Dilli E, Aube M, Leroux E, Becker WJ; Canadian Headache Society Acute Migraine Treatment Guideline Development Group. Canadian Headache Society Guideline: acute drug therapy for migraine headache. Can J Neurol Sci. 2013Abstract Full text (in our servers)
  8. Sachs HC; Committee On Drugs. The transfer of drugs and therapeutics into human breast milk: an update on selected topics. Pediatrics. 2013Abstract Full text (link to original source) Full text (in our servers)
  9. Amir LH, Pirotta MV, Raval M. Breastfeeding--evidence based guidelines for the use of medicines. Aust Fam Physician. 2011Abstract Full text (link to original source) Full text (in our servers)
  10. Zrour-Hassen S, Jguirim M, Aouam K, Korbaa W, Younes M, Bejia I, Touzi M, Bergaoui N. [Safety of rheumatic disease drugs at childbearing age]. Therapie. 2010Abstract
  11. Zrour-Hassen S, Jguirim M, Aouam K, Korbaa W, Younes M, Bejia I, Touzi M, Bergaoui N. [Safety of rheumatic disease drugs at childbearing age]. Therapie. 2010Abstract
  12. Chen LH, Zeind C, Mackell S, LaPointe T, Mutsch M, Wilson ME. Breastfeeding travelers: precautions and recommendations. J Travel Med. 2010Abstract Full text (link to original source) Full text (in our servers)
  13. Østensen M, Motta M. Therapy insight: the use of antirheumatic drugs during nursing. Nat Clin Pract Rheumatol. 2007Abstract
  14. Bar-Oz B, Bulkowstein M, Benyamini L, Greenberg R, Soriano I, Zimmerman D, Bortnik O, Berkovitch M. Use of antibiotic and analgesic drugs during lactation. Drug Saf. 2003Abstract
  15. Bannwarth B, Péhourcq F. [Pharmacologic basis for using paracetamol: pharmacokinetic and pharmacodynamic issues]. Drugs. 2003Abstract
  16. WHO / UNICEF. BREASTFEEDING AND MATERNAL MEDICATION Recommendations for Drugs in the Eleventh WHO Model List of Essential Drugs. Department of Child and Adolescent Health and Development (WHO/UNICEF) 2002 Full text (link to original source) Full text (in our servers)
  17. AAP - American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001Abstract Full text (link to original source) Full text (in our servers)
  18. Janssen NM, Genta MS. The effects of immunosuppressive and anti-inflammatory medications on fertility, pregnancy, and lactation. Arch Intern Med. 2000Abstract Full text (link to original source) Full text (in our servers)
  19. Spigset O, Hägg S. Analgesics and breast-feeding: safety considerations. Paediatr Drugs. 2000Abstract
  20. Nice FJ, Snyder JL, Kotansky BC. Breastfeeding and over-the-counter medications. J Hum Lact. 2000Abstract
  21. Mitchell JL. Use of cough and cold preparations during breastfeeding. J Hum Lact. 1999Abstract
  22. Bodley V, Powers D. Long-term treatment of a breastfeeding mother with fluconazole-resolved nipple pain caused by yeast: a case study. J Hum Lact. 1997Abstract
  23. Lee JJ, Rubin AP. Breast feeding and anaesthesia. Anaesthesia. 1993Abstract Full text (link to original source) Full text (in our servers)
  24. Ito S, Blajchman A, Stephenson M, Eliopoulos C, Koren G. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993Abstract
  25. Notarianni LJ, Oldham HG, Bennett PN. Passage of paracetamol into breast milk and its subsequent metabolism by the neonate. Br J Clin Pharmacol. 1987Abstract Full text (link to original source)
  26. Matheson I, Lunde PK, Notarianni L. Infant rash caused by paracetamol in breast milk? Pediatrics. 1985Abstract
  27. Bitzén PO, Gustafsson B, Jostell KG, Melander A, Wåhlin-Boll E. Excretion of paracetamol in human breast milk. Eur J Clin Pharmacol. 1981Abstract
  28. Findlay JW, DeAngelis RL, Kearney MF, Welch RM, Findlay JM. Analgesic drugs in breast milk and plasma. Clin Pharmacol Ther. 1981Abstract
  29. Berlin CM Jr, Yaffe SJ, Ragni M. Disposition of acetaminophen in milk, saliva, and plasma of lactating women. Pediatr Pharmacol (New York). 1980Abstract
  30. Hurden E L, Harvey D R, Lewis P J. Excretion of paracetamol in human breast milk. In: Neonatal Society Meeting held on 4 July 1980 in Southampton. Arch Dis Child. 1980Abstract Full text (link to original source) Full text (in our servers)