| 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. |
