Last update April 26, 2022

Propylthiouracil (PTU)

Compatible

Safe substance and/or breastfeeding is the best option.

Anti-thyroid drug that blocks the production of thyroid hormones. Indicated in hyperthyroidism. Oral administration in one to two daily doses.

Small amount of Propylthiouracil can reach the breast milk and it doesn't cause harm to the thyroid function.(Low 1979, Kampmann 1980, Cooper 1987)

Several medical societies, experts and expert consensus, consider the use of this medication to be safe during breastfeeding. (Hale, LactMed, Peng 2022, Dumitrascu 2021, Amino 2020, Alexander 2017, Stagnaro 2011, Inoue 2009, Glatstein 2009, Marx 2008, Azizi 2006, Bartalena 2005, Mandel 2001, Momotani 2000 & 1989, Cooper 1987, McDougall 1986, Kampmann 1980 )

The American Thyroid Association and other authors (Amino 2020, Alexander 2017, Stagnaro 2011, Mandel 2001) stated that a daily dose as high as 450 mg is safe while breastfeeding. However, some studies have shown no harmful effect at a daily dose as high as 750 mg (Inoue 2009, Glatstein 2009, Marx 2008, Azizi 2006, Bartalena 2005, Momotani 2000 y 1989, Cooper 1987, McDougall 1986, Kampmann 1980). Some author recommend a maximum of 300 mg daily during breastfeeding. (Dumitrascu 2021)

Routine laboratory monitoring of thyroid function is not recommended in healthy infants who are developing well clinically. (Alexander 2017)

Methimazole or Carbimazole is preferred since liver toxicity has been found among patients who were treated with Propylthiouracil. (Karras 2009, 2010 y 2012, Azizi 2011, Serrano 2014, Hudzik 2016)

No se precisa 

The American Academy of Pediatrics has rated it as compatible with breastfeeding. (AAP 2001)

Eleventh WHO Model List of Essential Drugs 2002: Compatible with breastfeeding. (OMS 2002)

Alternatives

  • Methimazole (Safe substance and/or breastfeeding is the best option.)

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Propylthiouracil (PTU) in other languages or writings:

Group

Propylthiouracil (PTU) belongs to this group or family:

Tradenames

Main tradenames from several countries containing Propylthiouracil (PTU) in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 95 %
Molecular weight 170 daltons
Protein Binding 80 %
VD 0.87 l/Kg
Tmax 1 - 2 hours
1 - 2 hours
M/P ratio 0.09 -
Theoretical Dose 0.1 mg/Kg/d
Relative Dose 2.1 %
Ped.Relat.Dose 1 - 2 %

References

  1. LactMed. Drugs and Lactation Database (LactMed). Internet. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/ 2006 - Consulted on April 16, 2024 Full text (link to original source)
  2. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Consulted on April 10, 2024 Full text (link to original source)
  3. Peng CC, Pearce EN. An update on thyroid disorders in the postpartum period. J Endocrinol Invest. 2022 Feb 18. Consulted on April 26, 2022 Abstract
  4. Dumitrascu MC, Nenciu AE, Florica S, Nenciu CG, Petca A, Petca RC, Comănici AV. Hyperthyroidism management during pregnancy and lactation (Review). Exp Ther Med. 2021 Sep;22(3):960. Abstract
  5. Amino N, Arata N. Thyroid dysfunction following pregnancy and implications for breastfeeding. Best Pract Res Clin Endocrinol Metab. 2020 Jul;34(4):101438. Abstract
  6. Alexander EK, Pearce EN, Brent GA, Brown RS, Chen H, Dosiou C, Grobman WA, Laurberg P, Lazarus JH, Mandel SJ, Peeters RP, Sullivan S. 2017 Guidelines of the American Thyroid Association for the Diagnosis and Management of Thyroid Disease During Pregnancy and the Postpartum. Thyroid. 2017 Abstract Full text (link to original source) Full text (in our servers)
  7. Hudzik B, Zubelewicz-Szkodzinska B. Antithyroid drugs during breastfeeding. Clin Endocrinol (Oxf). 2016 Abstract
  8. Serrano Aguayo P, García de Quirós Muñoz JM, Bretón Lesmes I, Cózar León MV. Tratamiento de enfermedades endocrinológicas durante la lactancia. [Endocrinologic diseases management during breastfeeding.] Med Clin (Barc). 2015 Jan 20;144(2):73-9. Abstract
  9. Lazarus JH. Pre-conception counselling in graves' disease. Eur Thyroid J. 2012 Abstract Full text (link to original source) Full text (in our servers)
  10. Karras S, Krassas GE. Breastfeeding and antithyroid drugs: a view from within. Eur Thyroid J. 2012 Abstract Full text (link to original source) Full text (in our servers)
  11. Azizi F, Amouzegar A. Management of hyperthyroidism during pregnancy and lactation. Eur J Endocrinol. 2011 Abstract Full text (link to original source) Full text (in our servers)
  12. Stagnaro-Green A, Abalovich M, Alexander E, Azizi F, Mestman J, Negro R, Nixon A, Pearce EN, Soldin OP, Sullivan S, Wiersinga W; American Thyroid Association Taskforce on Thyroid Disease During Pregnancy and Postpartum.. Guidelines of the American Thyroid Association for the diagnosis and management of thyroid disease during pregnancy and postpartum. Thyroid. 2011 Abstract Full text (link to original source) Full text (in our servers)
  13. Karras S, Tzotzas T, Kaltsas T, Krassas GE. Pharmacological treatment of hyperthyroidism during lactation: review of the literature and novel data. Pediatr Endocrinol Rev. 2010 Abstract
  14. Inoue M, Arata N, Koren G, Ito S. Hyperthyroidism during pregnancy. Can Fam Physician. 2009 Abstract Full text (link to original source) Full text (in our servers)
  15. Karras S, Tzotzas T, Krassas GE. Antithyroid drugs used in the treatment of hyperthyroidism during breast feeding. An update and new perspectives. Hormones (Athens). 2009 Abstract Full text (link to original source) Full text (in our servers)
  16. Fumarola A, Calvanese A, Di Fiore A, Dainelli M, D'Armiento M. [Antithyroid drugs therapy]. Clin Ter. 2009 Abstract
  17. Glatstein MM, Garcia-Bournissen F, Giglio N, Finkelstein Y, Koren G. Pharmacologic treatment of hyperthyroidism during lactation. Can Fam Physician. 2009 Abstract Full text (link to original source) Full text (in our servers)
  18. Azizi F. The safety and efficacy of antithyroid drugs. Expert Opin Drug Saf. 2006 Abstract
  19. Koren G, Soldin O. Therapeutic drug monitoring of antithyroid drugs in pregnancy: the knowledge gaps. Ther Drug Monit. 2006 Abstract Full text (link to original source) Full text (in our servers)
  20. Azizi F. Treatment of post-partum thyrotoxicosis. J Endocrinol Invest. 2006 Abstract
  21. Clark SM, Saade GR, Snodgrass WR, Hankins GD. Pharmacokinetics and pharmacotherapy of thionamides in pregnancy. Ther Drug Monit. 2006 Abstract
  22. Bartalena L, Tanda ML, Bogazzi F, Piantanida E, Lai A, Martino E. An update on the pharmacological management of hyperthyroidism due to Graves' disease. Expert Opin Pharmacother. 2005 Abstract Full text (link to original source) Full text (in our servers)
  23. Nice FJ, De Eugenio D, Dimino TA, Freeny IC, Rovnack MB, Gromelski JS. Medications and Breast-Feeding: A Guide for Pharmacists, Pharmacy Technicians, and Other Healthcare Professionals. Part I. J Pharm Technol 2004;20:17-27. doi: 10.1177/875512250402000106.
  24. 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 Abstract Full text (link to original source) Full text (in our servers)
  25. AAP - American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89. Abstract Full text (link to original source) Full text (in our servers)
  26. Mandel SJ, Cooper DS. The use of antithyroid drugs in pregnancy and lactation. J Clin Endocrinol Metab. 2001 Abstract Full text (link to original source) Full text (in our servers)
  27. Lee A, Moretti ME, Collantes A, Chong D, Mazzotta P, Koren G, Merchant SS, Ito S. Choice of breastfeeding and physicians' advice: a cohort study of women receiving propylthiouracil. Pediatrics. 2000 Abstract Full text (link to original source) Full text (in our servers)
  28. Azizi F, Khoshniat M, Bahrainian M, Hedayati M. Thyroid function and intellectual development of infants nursed by mothers taking methimazole. J Clin Endocrinol Metab. 2000 Abstract Full text (link to original source) Full text (in our servers)
  29. Momotani N, Yamashita R, Makino F, Noh JY, Ishikawa N, Ito K. Thyroid function in wholly breast-feeding infants whose mothers take high doses of propylthiouracil. Clin Endocrinol (Oxf). 2000 Abstract
  30. Momotani N, Yamashita R, Yoshimoto M, Noh J, Ishikawa N, Ito K. Recovery from foetal hypothyroidism: evidence for the safety of breast-feeding while taking propylthiouracil. Clin Endocrinol (Oxf). 1989 Abstract
  31. Goldman JM. Propylthiouracil and breast-feeding. CMAJ. 1987 Abstract
  32. Cooper DS. Antithyroid drugs: to breast-feed or not to breast-feed. Am J Obstet Gynecol. 1987 Abstract
  33. McDougall IR, Bayer MF. Should a woman taking propylthiouracil breast-feed? Clin Nucl Med. 1986 Abstract
  34. Lamberg BA, Ikonen E, Osterlund K, Teramo K, Pekonen F, Peltola J, Välimäki M. Antithyroid treatment of maternal hyperthyroidism during lactation. Clin Endocrinol (Oxf). 1984 Abstract
  35. Kampmann JP, Hansen JM. Clinical pharmacokinetics of antithyroid drugs. Clin Pharmacokinet. 1981 Abstract
  36. Tegler L, Lindström B. Antithyroid drugs in milk. Lancet. 1980 Abstract
  37. Kampmann JP, Johansen K, Hansen JM, Helweg J. Propylthiouracil in human milk. Revision of a dogma. Lancet. 1980 Abstract
  38. Low LC, Lang J, Alexander WD. Excretion of carbimazole and propylthiouracil in breast milk. Lancet. 1979 Abstract

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