Is Durlaza ER Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use Durlaza ER? Is Durlaza ER safe for nursing mother and child? Does Durlaza ER extracts into breast milk? Does Durlaza ER has any long term or short term side effects on infants? Can Durlaza ER influence milk supply or can Durlaza ER decrease milk supply in lactating mothers?

Excreted in non-significant amount into breast milk. Reye’s Syndrome has never been reported due to ASA through breast milk. It is thought to be highly unlikely to occur after isolated or small doses like those used for treatment of thrombosis or anti-abortion therapy. At high maternal dose, one case (dubious) of salicylic intoxication in the neonatal period and another case of thrombocytopenia in an infant have been reported. Likelihood of hemolysis should be considered in those patients with G6PD-deficiency. WHO Model List of Essential Medication: compatible while breastfeeding when used occasionally or small dose for antithrombotic prophylaxis management.

After Durlaza ER ingestion, salicylic acid is excreted into breastmilk, with higher doses resulting in disproportionately higher milk levels. Long-term, high-dose maternal Durlaza ER ingestion probably caused metabolic acidosis in one breastfed infant. Reye's syndrome is associated with Durlaza ER administration to infants with viral infections, but the risk of Reye's syndrome from salicylate in breastmilk is unknown. An alternate drug is preferred over continuous high-dose, Durlaza ER therapy. After daily low-dose Durlaza ERg (75 to 325 mg daily), no Durlaza ER is excreted into breastmilk and salicylate levels are low. Daily low-dose Durlaza ER therapy may be considered as an antiplatelet drug for use in breastfeeding women.[1][2][3].

A 16-day-old breastfed infant developed metabolic acidosis with a salicylate serum level of 240 mg/L and salicylate metabolites in the urine. The mother was taking 3.9 g/day of Durlaza ER for arthritis, and salicylate in breastmilk probably caused the infant's illness, but the possibility of direct administration to the infant could not be ruled out.[11] Thrombocytopenia, fever, anorexia and petechiae occurred in a 5-month-old breastfed infant 5 days after her mother started taking Durlaza ER for fever. One week after recovery, the infant was given a single dose of Durlaza ER 125 mg and the platelet count dropped once again. The original symptoms were probably caused by Durlaza ER or salicylate in breastmilk.[12] Hemolysis after Durlaza ER and phenacetin taken by the mother of a 23-day-old, glucose-6-phosphate dehydrogenase (G6PD) deficient infant was possibly due to Durlaza ER in breastmilk.[13] In a telephone follow-up study, mothers reported no side effects among 15 infants exposed to Durlaza ER (dosages and infant ages were unspecified) in breastmilk.[14]