Last update: May 1, 2019
Increased level of risk
New scientific evidences have driven the Apilam staff to update the level of risk associated to this product.
Former level of risk, which was Low Risk probable, is now set to High Risk probable.
Level of risk reviewed on April 8, 2019
Poorly safe. Evaluate carefully.
Use safer alternative or interrupt breastfeeding several 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 breast milk at a concentration lower than what is considered to be significant: 6.2% versus 10%(Zylber 1986, Rizzoni 1984). It has been detected in plasma or urine of infants whose mothers were taking it (Rizzoni 1984).
No side effects have been reported in infants of mothers who take it except for a cyanotic crisis (Rizzoni 1984).
Increased risk of acute lymphocytic leukemia has been found in children whose mothers took metamizole during pregnancy and breastfeeding, whereas 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 of Europe and America (Witschi 2019, Bordini 2016, Chaves 2009, Sabo 2001, DUP 1992). This has not been the case in the USA and UK since the 1970s due to the risk of exanthemas, 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 uncommon (none in relation to breastfeeding), but there have been significant variations in the risk of agranulocytosis: from 1 per 1,400 treatments in Sweden to 1 in half a million in Greece, suggesting that the risk would be linked to ethnicity with a specific HLA allele, being the highest among descendants of Celto-Briton populations (Shah 2019, Mérida 2009).
The risk is lower in the pediatric age and its analgesic effect is not higher than that of intravenous paracetamol (Ziesenitz 2018, de Leeuw 2017).
The European Medicines Agency has unified the Metamizol information for European countries, limiting the dose and use, both in adults and infants and children and during breastfeeding (EMA 2019 and 2018).
American Academy of Pediatrics: medication which is usually compatible with breastfeeding (AAP 2001).
Until there is more published data on this drug in relation to breastfeeding, it is recommended a punctual and limited use, being preferable safer known alternatives (Bar-Oz 2003), especially during the neonatal period and in case of prematurity.
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.
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