Medication Use and Breastfeeding

Recommendations regarding breastfeeding in situations in which the mother is undergoing pharmacologic therapy must balance the benefits to the infant and the mother against the potential risk of drug exposure to the infant.

There are only a limited number of agents that are contraindicated, and an appropriate substitute usually can be found.
The most comprehensive, up-to-date source of information regarding the safety of maternal medications, as well as recommended alternatives to less desirable medications, when the mother is breastfeeding is LactMed, an Internet-accessed source published by the National Library of Medicine/National Institutes of Health.
An AAP policy statement on the transfer of drugs and other chemicals into human milk provides additional recommendations, with particular focus on psychotropic drugs, herbal products, galactagogues, narcotics, and pain medications.
In general, breastfeeding is not recommended when mothers are receiving medication from the following classes of drugs: amphetamines, chemotherapy agents, ergotamines, and statins.¹
Dr. Thomas Hale’s Medications and Mother’s Milk Lactation Risk Categories are used by many for determining the risk of medication use while nursing. The categories are listed below in order from safest to contraindicated during lactation.

Pain Management:

Pain management during breastfeeding illustrates some of the medication and breastfeeding considerations. It is undeniable that labor and delivery is a major event with the potential to inflict trauma on the mother’s body. Following delivery, particularly a cesarean, pain medication is often used. Additionally, mothers who have existing conditions involving pain will still need pain relief while nursing.³⁶ Babies who are unusually sleepy and poor feeders may be associated with moms who are using narcotics chronically and many days after delivery.

Non-steroidal Anti-inflammatory Drugs (NSAIDs):

NSAIDs are compatible with breastfeeding.
Ibuprofen is a better choice than naproxen due to its shorter half-life.
Of the prescription agents, immediate-release diclofenac appears to have low levels in breast milk.
Limited data are available for meloxicam, but drug properties of good bioavailability and long half-life make this an unfavorable choice.
Celecoxib also has limited data, but it appears that milk levels would be low.

Acetaminophen:

Safe in both pregnancy and lactation, with a lactation risk category of L1.
Studies have shown a variable relative infant dose, but the concentration that appears in breast milk is well below the pediatric therapeutic dose.
While pediatric concerns have not been reported, mothers should still be advised of the maximum acetaminophen dosing and warned against using multiple products containing acetaminophen concurrently.

Aspirin:

Lactation risk category of L3, associated with significant side effects and should be given with caution.
Extremely high doses in mother can potentially produce slight bleeding in infant.
Aspirin is associated with Reye Syndrome, and therefore should be avoided in lactating mothers.

Narcotic pain relievers:

Limited data are available for many pain relievers.
Hydrocodone-containing medications are commonly used postpartum. Infants should be monitored for sedation, apnea and constipation.
Oxycodone-containing medications are used after cesarean deliveries or for mothers who have additional surgery or significant pain. Infants should also be monitored for sedation, apnea and constipation.
Fentanyl is used in epidurals and in various forms (patch, spray, lozenge). Concentrations of fentanyl in colostrum following delivery is very low.
The FDA has issued a warning on the use of codeine and Tramadol for the breastfeeding mother. Risks include serious side effects in the infant such as excess sleepiness. difficulty breastfeeding, or serious breathing problems that could resul in death of the infant.

If a mother must take a medication while breastfeeding, there are several ways to minimize her infant’s exposure to that medication. These recommendations include the following:

Avoid recommending sustained-release products.
Suggest that a mother can alter the time she takes a medication.
- Once-daily dosed medications should be administered just before the infant’s longest sleep interval, usually after the bedtime feeding.
- Mothers can also pump before taking their medications, saving the fresh milk for later feedings.
Recommend older generation drugs with more established data over new products.
Recommend the lowest effective dose to minimize the effects on the child.
Note if a medication impacts milk production, particularly if it decreases milk supply.
Consider what may be safe to take when nursing older babies compared with newborns and premature or sick infants.

Hale’s Medications and Mother’s Milk Lactation Risk Categories:

Lactation Category	Description
L1 – Safest	These drugs have 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	These drugs have 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 researching the use of these medications 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. These 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 – Possibly Hazardous	There is positive evidence of risk to a breastfed infant or to breast milk production, but the benefits from use of these drugs 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 these drugs in breastfeeding women clearly outweighs any possible benefit from breastfeeding. The drug is contraindicated in women who are breastfeeding an infant.