L1

Safest

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

Safer

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

Moderately Safe

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 non-threatening adverse effects. Drugs should be given only if the potential benefit justifies the potential risk to the infant.

L4

Possibly Hazardous

There is positive evidence of risk to a breastfed infant or to breastmilk 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

Contraindicated

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.

定   義

L1

在授乳婦女的對照研究中，無法證實對嬰兒有風險或是此類藥物不會被嬰兒口服吸收。因此授乳時可以使用。

L2

這類藥品不會對嬰兒造成副作用，但研究數據有限或是臨床上觀察到的副作用微乎其微。因此授乳時可以使用，但必須監測嬰兒是否有副作用產生。

L3

在授乳婦女的對照研究中，顯示對嬰兒有較小而不危及生命的副作用。該藥物只有在對嬰兒可能的利益大於潛在的危險才可使用。

L4

這類藥物對嬰兒會產生副作用或是抑制泌乳，若該藥物用於生命危急狀況或於嚴重疾病並無較安全藥物可替代時，對授乳有益時可使用。

L5

這類藥物會對嬰兒產生危險的副作用，因此授乳婦女禁用