Breastfeeding and OTC Drugs

General Information 

• In general, breast milk is considered a superior form of nutrition to ensure the health of the infant when compared to infant formulas. However, if a medication is needed to control a symptom, caution may be necessary to prevent exposure to infant during breast-feeding. 
• In most cases, only a small amount of drug (1-2%) ends up in breast milk which is usually harmless to the infant.
• Although, adverse drug reactions during breast feeding are rare, they are more likely to occur in premature infants or in infants 2 months or younger.
• Despite the common misconception the breast is like a bladder where drugs just accumulate, it is a compartment where drugs can diffuse out over time. Thus, in most cases you can minimize exposure to the infant if you just take the medication right after you have breast-fed the baby or right after the baby is due for a long sleep. Note: It is rarely necessary to pump and discard breast milk after a medication has been taken by the mother to reduce infant exposure (only in exceptional circumstances involving a contraindicated drug).
• The drug's characteristics determine how much of  the drug will pass into the mother's breast milk.  For instance, drugs that have a low molecular weight (MW<500), are very lipid soluble, have low protein binding, are weak bases and drugs with long half-lives are more likely to accumulate in breast milk. 
• Read the "Warning" section of the OTC product label for information regarding use of drugs during breastfeeding.

General Guidelines Involving OTC Medication Use During Breastfeeding

• If possible, try not to use any OTC medications to treat symptoms first.
• Avoid alcohol containing medication preparations when possible.
• If you cannot avoid medication therapy, try to use single ingredient OTC products to treat your symptom(s), avoid extra-strength and long-acting/sustained release formulations of the medication to reduce number of medications and overall exposure to the breastfeeding infant.
• Watch the infant closely during breast-feeding to see if adverse reactions occur (i.e. changes in behavior such as irritability, loss of appetite, sleepiness or other reactions like skin rash, vomiting, diarrhea, colic etc.).
• Time medication administration after breast feeding is completed or just after the baby is put to bed for an extended period of time.
• Vitamin and mineral administration is generally fine if taken within normal dosage ranges.
• Please check with pharmacist or doctor regarding all medications and herbal remedies if you do not know the safety of the product during breastfeeding. 
• You may use the following websites to check the safety of common medicines and herbal products during breastfeeding. Drugs and Lactation Database (LactMed) http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT (a peer-reviewed and fully referenced database) along with the following websites that give some basic information about safety of medications/herbal products during breastfeeding http://www.itmonline.org/arts/breast.htm, http://kellymom.com/bf/got-milk/herbs_to_avoid/.
• In general, avoid aspirin and all aspirin containing products (i.e. Pepto Bismal, Alka Seltzer, Anacin, Excedrin, Bayer Aspirin etc.) due to risk of bleeding  and  Reye Syndrome in the infant http://www.reyessyndrome.org/what.html .
• Use acetaminophen (Tylenol) or ibuprofen (Advil) for pain/fever relief since they both have a shorter half-life, enter breast milk at very small concentrations and are considered by most experts to be drugs of choice while breastfeeding. 
• Loratidine (Claritin) is considered by many experts to be the OTC antihistamine of choice. Other antihistimines may decrease milk supply and cause adverse side effects (i.e. drowsiness, irritability, colicky symptoms, refusal to feed etc.). Although not contraindicated, limit exposure to other antihistamines (i.e. chlorpheniramine (Chlor-Trimeton), clemastine (Tavist), diphenhydramine (Benadryl), doxylamine (Nyquil).
• Nasal decongestants (i.e. phenylephrine (Neo-Synephrine), oxymetazolone (Afrin) are preferred over oral decongestants like pseudoephrine (Sudafed) because nasal decongestants are locally administered and have limited absorption into the maternal blood stream.
• Antacids like aluminum hydroxide (Alternagel, Amphojel),magnesium hydroxide, calcium carbonate (Tums) and combinations with simethicone are all compatible with breastfeeding (i.e. Mylanta, Maalox).
• Although H2 antagonists (i.e. ranitidine(Zantac), famotidine(Pepcid), cimetidine(Tagamet), nizatidine(Axid) are not contraindicated during breastfeeding, however, antacids are preferred to treat heartburn/upset stomach symptoms since oral absorption is quite limited.
• Proton pump inhibitors (i.e. omeprazole (Prilosec OTC)) are generally not recommended as a first line treatment during breastfeeding and should be reserved if only deemed necessary by your physician. 
• Antitussives/expectorants (i.e. guafenesin (Robitussin), dextromethorphan (Robitussin DM))are generally compatible with breastfeeding.
• Most topical OTC creams and ointments when used short term are compatible with breastfeeding (except acne creams which have not been studied extensively). Note: If the area of use is the breast itself wipe the area clean prior to breastfeeding.

Lactation Risk Categories

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, bu 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.

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Sources for this post include:

http://pediatrics.aappublications.org/content/108/3/776.full.pdf

Briggs GG,Freeman RK, Yaffe SJ, Drugs in Pregnancy and Lactation 6th edition,Baltimore, MD: Williams & Wilkins,2002.

http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 

http://www.breastfeedingbasics.com/articles/drugs-and-breastfeeding
http://otcsafety.org/en/experts/questions-breastfeeding-moms-ask-about-otc-medicines/
http://www.medsmilk.com/pages/introduction
http://www.uspharmacist.com/content/c/10278/?t=women's_health
http://www.ncbi.nlm.nih.gov/pubmed/18603972
http://www.elpasotimes.com/living/ci_21187589/breast-feeding-is-beneficial-but-be-aware-drug
http://www.infantrisk.com/content/drug-entry-human-milk
http://www.infantrisk.com/content/safely-managing-pain-during-lactation
http://www.medsafe.govt.nz/Profs/PUarticles/lactation.htm#Transfer
http://www.itmonline.org/arts/breast.htm
http://tidsskriftet.no/article/2269161/en_GB/
http://kellymom.com/bf/got-milk/herbs_to_avoid/
http://www.lalecheleague.org/ba/nov97.html
http://pharmacistsletter.therapeuticresearch.com/home.aspx?cs=&s=PL