Last update: Aug. 21, 2021
Moderately safe. Probably compatible.
Mild risk possible. Follow up recommended.
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Oral administration once a day.
It is excreted in breast milk in a small amount (Lopes 2018, Weisskopf 2017, Salazar 2016, Berle 2004, Heikkinen 2003, Suri 2002, Hendrick 2001, Kristensen 1999, Yoshida 1998, Burch 1992, Isenberg 1990), although greater than that of other antidepressants of the same SSRI group with relative dose > 10 % (Pogliani 2019, Sriraman 2015, Sachs 2013, Taddio 1996, Nordeng 2001).
Plasma levels of infants whose mothers took fluoxetine were undetectable or at low therapeutic limits (Weissman 2004, Epperson 2003, Hendrick 2001, Birnbaum 1999, Brent 1998, Yoshida 1998).
Few cases of colicky pain, irritability, insomnia, anorexia and slow weight gain have been described (Kristensen 1999, Chambers 1999, Lester 1993), but most reported cases have failed to show harm effect outside the newborn period (Taddio 1996). Large experience with the use of Fluoxatine did not find harm effect on weight gain and neurological development of infants either at short or long term (Pogliani 2019, Gashlin 2016, Epperson 2003, Heikkinen 2003, Hendrick 2003, Nulman 2002, Hendrick 2001, Birnbaum 1999, Yoshida1998).
Transient troubles in the early neonatal period (poor adaptation or hyperstimulation of serotonin) among newborn or premature infants with high serum levels as a result of treatment with fluoxetine to the mother during pregnancy have been observed (Kieviet 2015, Morris 2015, Hale 2010, Nordeng 2001).
Fluoxetine, like other antidepressants, can cause galactorrhea problems and or hyperprolactinaemia (Suthar 2018, Kaba 2017, Trenque 2011, Papakostas 2006, Peterson 2001, Egberts 1997, Arya 1995).
Several medical societies, experts and expert consensus, consider the use of this medication safe or probably safe during breastfeeding (Hale, Lactmed, Uguz 2021, Amir 2011, Berle 2011, Lanza 2009, ABM 2008, Pomp 2001).
Safer known alternatives may be preferable, especially during the neonatal period and in cases of prematurity (Davanzo 2011, Patil 2011, Gentile 2005, Rubin 2004, Weissman 2004, Gjerdingen 2003, Wisner 2002, Nordeng 2001, Wisner 1996).
Women suffering from depression during pregnancy need more breastfeeding support due to their increased risk of breastfeeding problems and early weaning (Grzeskowiak 2018, Leggett 2017, Gorman 2012).
Suggestions made at e-lactancia are done by APILAM´s pediatricians and pharmacists, and are based on updated scientific publications.
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