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A comprehensive review of assay methods to determine drugs in breast milk and the safety of breastfeeding when taking drugs


Most of the licit and illicit drugs consumed by the breastfeeding woman pass into the milk and can modify the production, volume and composition of the milk, as well as hypothetically have short- and long-term harmful effects on the infant. There is much confusion in the scientific community regarding this issue: should a woman breastfeed her baby while continuing to use prescription drugs and/or drugs of abuse? There are many case reports of clinically significant toxicity in breast-fed infants from some substances used by mothers (such as irritability, vomiting, sedation, respiratory depression, shock), but there are too few data on studies conducted in breastfeeding women and their infants to make a realistic risk assessment. The objective measurement of a drug and/or metabolites in maternal milk is the first step when investigating the amount of drug exctreted in milk and subsequently calculating the daily dose administered to the breast-fed infant. The present review reports the analytical methods developed to detect different drugs in the breast milk, listing the principal characteristics and validation parameters, advantages and disadvantges. Furthermore, the mechanisms of drug transfer into breast milk are discussed, the correlation between the concentration of the drug in breast milk and potential adverse outcomes on the infant are described for each drug, and suggested harm minimization strategies and approved breastfeeding recommendations are indicated.

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American Academy of Pediatrics


Atmospheric pressure ionization














Diode array detector




Electron capture detection






Ecgonine methyl ester


Enzyme immunoassay


Enzyme multiplied immunoassay technique


Electrospray ionization


Flame ionization detector


Fluorescence polarization immunoassay


Gas chromatography

t 1/2 :



High-performance liquid chromaqtography


Liquid chromatography









M/P ratio:

Milk/plasma ratio




Mass spectrometry


Tandem mass spectrometry


Negative chemical ionization mode




Nitrogen phosphorus detector


Patient-controlled analgesia




Selective serotonin reuptake inhibitors


Solid-phase extraction


Tandem mass spectrometry assay




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Correspondence to Oscar García-Algar.

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Fríguls, B., Joya, X., García-Algar, O. et al. A comprehensive review of assay methods to determine drugs in breast milk and the safety of breastfeeding when taking drugs. Anal Bioanal Chem 397, 1157–1179 (2010).

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  • Biological samples
  • Clinical
  • Biomedical analysis
  • Drug monitoring
  • Drug screening
  • Pharmaceuticals