Hale's Medications & Mothers' Milk Online

■Lactation Risk Categories(LRC)

LRCとは、医薬品を母親が用いた場合に、授乳によって乳児へどのくらいの危険性および有害性が見込まれるかを示す分類。
本書ではL1、L2、L3、L4、L5の5段階に分類しています。

L1 Compatible:
Drug which has been taken by a large number of breastfeeding mothers without any observed increase in adverse effects in the infant. Controlled studies in breastfeeding women fail to demonstrate a risk to the infant and the possibility of harm to the breastfeeding infant is remote, or the product is not orally bioavailable in an infant.

L2 Probably Compatible:
Drug which has been studied in a limited number of breastfeeding women without an increase in adverse effects in the infant, and/or the evidence of a demonstrated risk which is likely to follow use of this medication in a breastfeeding woman is remote.

L3 Presumed Compatible:
There are no controlled studies in breastfeeding women; however, the risk of untoward effects to a breastfed infant is possible, or controlled studies show only minimal nonthreatening adverse effects. Drugs should be given only if the potential benefit justifies the potential risk to the infant. (New medications that have absolutely no published data are automatically categorized in this category, regardless of how safe they may be.)

L4 Potentially Hazardous:
There is positive evidence of risk to a breastfed infant or to breast-milk production, but the benefits from use in breastfeeding mothers may be acceptable despite the risk to the infant (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

L5 Hazardous:
Studies in breastfeeding mothers have demonstrated that there is significant and documented risk to the infant based on human experience, or it is a medication that has a high risk of causing significant damage to an infant. The risk of using the drug in breastfeeding women clearly outweighs any possible benefit from breastfeeding. The drug is contraindicated in women who are breastfeeding an infant.