Last update: Aug. 7, 2019

Метамизол Натрий

High Risk for breastfeeding


Poorly safe. Evaluate carefully.
Use safer alternative or interrupt breastfeeding 3 to 7 T½.
Read the Comment.

Metamizole or dipyrone is an analgesic and antipyretic drug derived from pyrazolone. Oral, rectal, intramuscular or intravenous administration every 6 to 8 hours.

It is excreted in breastmilk at concentrations which are lower than those that would be considered significant: 6.2% versus 10% (Zylber 1986, Rizzoni 1984). It has been detected in plasma or in the urine of infants whose mothers were taking it (Rizzoni 1984).

No side effects have been observed in infants of mothers taking it except for a cyanotic crisis (Rizzoni 1984).

An increased risk of acute lymphocytic leukemia has been found in children whose mothers took metamizole during pregnancy and breastfeeding, while the use of paracetamol during pregnancy was a protective factor (Couto 2015).

Authorized and widely used in childbirth, puerperium and pediatric analgesia in several countries in Europe and America (Witschi 2019, Bordini 2016, Chaves 2009, Sabo 2001, DUP 1992); this is not the case in the US and UK since the 1970s due to risk of skin rashes, anaphylaxis and agranulocytosis (<2 per million), which is actually lower than other medicines (Bordini 2016).

Serious complications reported in Germany, Spain, Poland, Switzerland and Latin America have been very rare (none in relation to breastfeeding), but significant variations in the risk of agranulocytosis have been observed: from 1 per 1,400 treatments in Sweden to 1 in half a million in Greece, suggesting that the risk could be linked to ethnicity with a specific HLA allele, being maximum among descendants of Celtic-British populations (Shah 2019, Mérida 2009). The risk is lower in the pediatric age group and its analgesic effect is not greater than that of intravenous paracetamol (Ziesenitz 2018, from Leeuw 2017).

The European Medicines Agency has standardized information on metamizole for European countries, limiting its dose and use, both in adults and in infants and children and during breastfeeding (EMA 2019 and 2018).

American Academy of Pediatrics: this medication is usually compatible with breastfeeding (AAP 2001).

Until there is more published data on this drug in relation to breastfeeding, occasional and limited use is recommended, and safer known alternatives are preferable (Bar-Oz 2003), especially during the neonatal period and in cases of prematurity.

Alternatives

Suggestions made at e-lactancia are done by APILAM´s pediatricians and pharmacists, and are based on updated scientific publications.
It is not intended to replace the relationship you have with your doctor but to compound it.

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

Метамизол Натрий is Metamizole in Cyrillic.

Is written in other languages:

Метамизол Натрий is also known as

Group

Метамизол Натрий belongs to this group or family:

Tradenames

Main tradenames from several countries containing Метамизол Натрий in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 85 %
Molecular weight 311 daltons
Protein Binding 60 %
VD 1,15 l/Kg
Tmax 1 - 2 hours
T1/2 10 - 11,2 hours
M/P ratio 1,5 -
Theoretical Dose 3,1 mg/Kg/d
Relative Dose 3,1 - 6,2 %
Relat.Ped.Dose 6,2 %

References

  1. Shah RR. Metamizole (dipyrone)-induced agranulocytosis: Does the risk vary according to ethnicity? J Clin Pharm Ther. 2019 Feb;44(1):129-133. Abstract Full text (link to original source) Full text (in our servers)
  2. Witschi L, Reist L, Stammschulte T, Erlenwein J, Becke K, Stamer U. [Perioperative use of metamizole and other nonopioid analgesics in children : Results of a survey]. Anaesthesist. 2019 Mar;68(3):152-160. Abstract
  3. EMA. Committee for Medicinal Products for Human Use (CHMP). Referral under Article 31 of Directive 2001/83/EC metamizole-containing medicinal products. https://www.ema.europa.eu/en/documents/referral/metamizole-article-31-referral-chmp-assessment-report_en.pdf Full text (link to original source) Full text (in our servers)
  4. Ziesenitz VC, Erb TO, Trachsel D, van den Anker JN. Safety of dipyrone (metamizole) in children-What's the risk of agranulocytosis? Paediatr Anaesth. 2018 Feb;28(2):186-187. Abstract
  5. EMA. Metamizol. Anexo II. Conclusiones científicas. 2018 Full text (in our servers)
  6. EMA. Metamizole. Annex II. Scientific conclusions. 2018 Full text (in our servers)
  7. de Leeuw TG, Dirckx M, Gonzalez Candel A, Scoones GP, Huygen FJPM, de Wildt SN. The use of dipyrone (metamizol) as an analgesic in children: What is the evidence? A review. Paediatr Anaesth. 2017 Dec;27(12):1193-1201. Abstract
  8. Bordini CA, Roesler C, Carvalho Dde S, Macedo DD, Piovesan É, Melhado EM, Dach F, Kowacs F, Silva Júnior HM, Souza JA, Maciel JA Jr, Carvalho JJ, Speciali JG, Barea LM, Queiroz LP, Ciciarelli MC, Valença MM, Lima MM, Vincent MB. Recommendations for the treatment of migraine attacks - a Brazilian consensus. Arq Neuropsiquiatr. 2016 Abstract Full text (link to original source) Full text (in our servers)
  9. Couto AC, Ferreira JD, Pombo-de-Oliveira MS, Koifman S. Pregnancy, maternal exposure to analgesic medicines, and leukemia in Brazilian children below 2 years of age. Eur J Cancer Prev. 2015 Abstract
  10. Chaves RG, Lamounier JA, César CC. Self-medication in nursing mothers and its influence on the duration of breastfeeding. J Pediatr (Rio J). 2009 Abstract
  11. Mérida Rodrigo L, Faus Felipe V, Poveda Gómez F, García Alegría J. [Agranulocytosis from metamizole: a potential problem for the British population]. Rev Clin Esp. 2009 Apr;209(4):176-9. Spanish. Abstract
  12. 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. 2003 Abstract
  13. 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)
  14. Sabo A, Stanulović M, Jakovljević V, Grujić Z. Collaborative study on drug use in pregnancy: the results of the follow-up 10 years after (Novi Sad Centre). Pharmacoepidemiol Drug Saf. 2001 Abstract
  15. Levy M, Zylber-Katz E, Rosenkranz B. Clinical pharmacokinetics of dipyrone and its metabolites. Clin Pharmacokinet. 1995 Abstract
  16. Grupo de Trabajo DUP España. [The DUP Working Group Spain]. Estudio multicéntrico sobre el uso de medicamentos durante el embarazo en España (IV). Los fármacos utilizados durante la lactancia. [A multicenter study of drug use during pregnancy in Spain (IV). The drugs used during lactation]. Med Clin (Barc). 1992 Abstract
  17. Zylber-Katz E, Linder N, Granit L, Levy M. Excretion of dipyrone metabolites in human breast milk. Eur J Clin Pharmacol. 1986 Abstract
  18. Rizzoni G, Furlanut M. Cyanotic crises in a breast-fed infant from mother taking dipyrone. Hum Toxicol. 1984 Abstract

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