1983;72;375-383 PediatricsCommittee on Drugs
The Transfer of Drugs and Other Chemicals into Human Breast Milk
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0 PEDIATRICS (ISSN 0031 4005). Copyright © 1983 by the
American Academy of Pediatrics.
0 Committee on Drugs
PEDIATRICS Vol. 72 No. 3 September 1983 375
The Transfer of Drugs and Other Chemicalsinto Human Breast Milk
In this statement, lists of the pharmacologic infant but indicates that there are no reports in the
agents transferred into human breast milk and their literature. These tables should assist the physician
possible effects on the infant or on lactation if in counseling a patient regarding breast-feedingknown are provided (Tables 1 to 4). The fact that when the patient has a condition for which a drug
TABLE 1. Drugs That Are Contraindicated During Breast-Feeding
Drug Reported Sign or Symptom in Infant or Effect on Lactation Reference
Amethopterin* Possible immune suppression; unknown effect on growth or association 1with carcinogenesis
Bromocriptine Suppresses lactation 2Cimetidinet May suppress gastric acidity in infant, inhibit drug metabolism, and 3
cause CNS stimulation
Clemastine Drowsiness, irritability, refusal to feed, high-pitched cry, neck stiffness 4Cyclophosphamide* Possible immune suppression; unknown effect on growth or association 5
with carcinogenesis
Ergotamine Vomiting, diarrhea, convulsions (doses used in migraine medications) 6Gold salts Rash, inflammation of kidney and liver 7, 8
Methimazole Potential for interfering with thyroid function 9Phenindione Hemorrhage 10Thiouracil Decreased thyroid function; does not apply to propylthiouracil 11
* Data not available for other cytotoxic agents. t Drug is concentrated in breast milk.
TABLE 2. Drugs That Require Temporary Cessation of Breast-Feeding
Drug Recommended Alteration in Breast-Feeding Pattern Reference
Metronidazole Discontinue breast-feeding 12-24 h to allow excretion of dose 12, 13Radiopharmaceuticals Radioactivity present in milk, consult nuclear medicine physi-
cian before performing diagnostic study so that radionuclidewhich has shortest excretion time in breast milk can be
used; prior to study the mother should pump her breast andstore enough milk in freezer for feeding the infant; afterstudy the mother should pump her breast to maintain milkproduction but discard all milk pumped for the requiredtime that radioactivity is present in milk.
Gallium-69 (69Ga) Radioactivity in milk present for 2 wk 14
Iodine-125 (125!) � Risk of thyroid cancer; radioactivity in milk present for 12 d 15Iodine-131 (‘�‘I) Radioactivity in milk present 2-14 d depending on study. 16-19Radioactive sodium Radioactivity in milk present 96 h 20Technetium-99m (9SmTc) Radioactivity in milk present 15 h to 3 d 21-25
99mTc macroaggregates,9SmTc 04
a pharmacologic agent does not appear on the listsis not meant to imply that it is not transferred into
breast milk or that it does not have an effect on the
is medically indicated.
These reports have been obtained from a search
of the medical literature. Because methodologies
used to quantitate drugs in breast milk continue to
improve, current information will require continu-
ous updating of the tables. Brand names are listed
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TABLE 3. Maternal Medication Usually Compatible with Breast-Feeding
Drug Reported Sign or Symptom in Infant or Effect Referenceon Lactation
ANESTHETICS, SEDATIVES oAlcohol Drowsiness, diaphoresis, deep sleep, weak- 26, 27
ness, decrease in linear growth, abnormalweight gain; maternal ingestion of 1 g/kg
daily decreases milk ejection reflexBarbiturate None; see antiepileptic drugs 28
Bromide Rash, weakness, absence of cry with mater- 29nal intake of 5.4 g/d
Chloral hydrate Sleepiness 30Chloroform None 31
Halothane None 32Magnesium sulfate None 33Methyprylon Drowsiness 34Secobarbital None 35
ANTICOAGULANTSBishydroxycoumarin None 36Warfarin None 37
ANTIEPILEPTICSCarbamazepine None 38Ethosuximide None 39Phenobarbital Methemoglobmemia (1 case); decreased re- 40, 41
sponsiveness, decreased weight gain, ex-cessive sleeping if mother’s plasma level�30 �g/mL
Phenytoin Methemoglobinemia (1 case) 41Primidone None 40, 42
Thiopental None 28Valproic acid None 43
ANTIHISTAMINES, DECONGESTANTS,AND BRONCHODILATORS
Dexbrompheniramine maleate with d-iso- Crying, poor sleeping patterns, irritability 44ephedrine
Diphenhydramine None 45Dyphyllinet None 46lodides Affects thyroid activity; see miscellaneous 47, 48
iodineTheophylline Irritability 49, 50Trimeprazine None 51
Tripelennamine None 52
ANTIHYPERTENSIVE AND CARDIO-VASCULAR DRUGS
Atenolol None 53Captopril None 54Digoxin None 55Disopyramide None 56Guanethidine None 47Hydralazine None 57Methyldopa None 58Metoprololt None 53Nadololt None 59Propranolol None 60-62Quinidine None 63Reserpine Galactorrhea 64
ANTIINFECTIVE DRUGS (ALL antibioticstransfer into breast milk in limitedamounts)
Amantadine Urinary retention, vomiting, and skin rash 51Cefadroxil None 65Cefazolin None 66Cefotaxime None 65
t Drug is concentrated in breast milk.
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TABLE 3.-Continued
Drug Reported Sign or Symptom in Infant or Effect Referenceon Lactation
0 Chloramphenicol None 67, 68Chloroquine None 69Clindamycin None 70Ethambutol None 71
Isoniazid None 72Nalidixic acid Hemolysis in infant with glucose-6-phos- 73
phate deficiency (G-6-PD)Nitrofurantoin Hemolysis in infant with G-6-PD 74Pyrimethamine None 75Quinine None 76Rifampin None 71Salicylazosulfapyridine (sulfasalazine) None 77, 78
Sulfapyridine Caution in infant with jaundice or G-6-PD, 77and ill, stressed, or premature infant
Sulfathiazole None; nonabsorbable by mother 79Sulfisoxazole Caution in infant with jaundice or G-6-PD, 80
and ill, stressed, or premature infantTetracycline None; negligible absorption by infant 81, 82Trimethoprim None 83
ANTITHYROID DRUGSCarbimazole Goiter 47, 51Propylthiouracil None 84
CATHARTICS (Drugs that cause abdominal Abdominal cramping, colic-like syndromecramping in mother)
Danthron Increased bowel activity 85
DIAGNOSTIC AGENTSIodine Goiter; see miscellaneous, iodine 16lopanoic None 86Metrizamide None 87
0 DIURETICSBendroflumethiazide Suppresses lactation, thrombocytopenia (1 88
case)Chlorothiazide May suppress lactation, therefore avoid 89, 90
prescribing in 1st month of lactation; thismay also apply to other thiazides; ques-tionably dose related
Chlorthalidone Excreted slowly 91Methyclothiazide None 92Spironolactone None 93
HORMONESChlorotrianisene None 513H-norethynodrel None 9419 norsteroid None 95Contraceptive pill with estrogen/progester- Breast enlargement, dose related; decrease 96-101one in milk production and protein contentEstradiol Withdrawal, vaginal bleeding 102, 103
MUSCLE RELAXANTSBaclofen None 104Carisoprodol Drowsiness, intestinal upset 105Methocarbamol None 106
NARCOTICS, NON-NARCOTIC ANALGE-SICS, ANTIINFLAMMATORYAGENTS
Acetaminophen None 107-109Butorphanol None 110Codeine None 79Flufenamic acid None 111Heroin None 112
O Ibuprofen None 113Indomethacin Seizure (1 case) 114, 115
AMERICAN ACADEMY OF PEDIATRICS 377 by on August 20, 2009 www.pediatrics.orgDownloaded from
Drug Reported Sign or Symptom in Infant or Effect Reference
on Lactation
Conflicting reports of drowsiness
None
51
51, 128-132
0
0
0
153
TABLE 3.-Continued
378 AGENTS TRANSFERRED INTO HUMAN BREAST MILK
Mefenamic acidMeperidine
MethadoneMorphine
NaproxenPhenylbutazone
Prednisolone, prednisonePropoxyphene
Salicylates
PSYCHOTROPIC AGENTSAntianxiety
ChlordiazepoxideClorazepate
DiazepamMeprobamatetOxazepamPrazepamt
AntidepressantsAmitriptyline
AmoxapineDesipramineDothiepin
ImipramineLithium
Tranylcypromine
Antipsychotic
Chlorpromazine
HaloperidolMesoridazine
PiperacetazineProchlorperazineThioridazineTrifluoperazine
Other
Marijuanat
STIMULANTSAmphetamineCaffeine
Nicotine (excess)
VITAMINSB1B12DFolic acidK1PyridoxineRiboflavin
Thiamin
MISCELLANEOUS
Atropine, scopolamineBethanecholDiphenoxylate with atropineIodine (providone-iodine/vaginal douche)
Tolbutamide
None
None
None if mother receiving �20 mg/24 hNone
None
None
None
None
Metabolic acidosis (dose related); may af-fect platelet function, rash
Galactorrhea in adult; drowsiness and leth-argy in infant
None
None
Unknown, only 1 report in literature
Irritability, poor sleeping patternIrritability, poor sleeping pattern excreted
slowlyShock, vomiting, diarrhea, rapid heart rate,
restlessness; decreased milk production
None
None
Increased calcium levels
None
None
None
NoneNone
None
Abdominal pain, diarrheaNone
Elevated iodine levels in breast milk, odorof iodine on infant’s skin
Jaundice
116
51
117
76
118
119
120, 121
122
123, 124
47, 125-127
133-135
51
136, 137
138
139
140
141
50, 142, 143
27
45
144
145
146147
148, 149
150
150
79, 151
34
152
48
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Reference
154
29, 155
156
50, 157
158159-162
TABLE 4. Food and Environmental Agents: Effect on Breast-Feeding
AMERICAN ACADEMY OF PEDIATRICS 379
Agent
AspartameBromide (photographic labora-
0 tory)ChlordaneChocolate
CyclamateDDT, benzenehexachlorides,
dieldrin, aldrin, hepatachlore-poxide
Fava beans
Fluorides
Hexachlorobenzene
Hexachlorophene
LeadMethyl mercuryMonosodium glutamate (MSG)Polychlorinated biphenyls and
polybrominated biphenylsSaccharinTetrachlorethylene (cleaning
fluid)Vegetarian diet
t Drug is concentrated in breast milk.
Reported Sign or Symptom in Infant or Effect on Lactation
Caution in patient carrier of phenylketonuriaPotential absorption and bromide transfer into milk;
see “Anesthetics, Sedatives”None reportedIrritability or increased bowel activity if excess
amounts ( 16 oz/d) consumed by motherNoneNone
Hemolysis in patient with glucose-6-phosphate defi-ciency (G-6-PD)
NoneSkin rash, diarrhea, vomiting, dark urine, neurotoxic-
ity, deathNone; contamination of milk from nipple washingNeurotoxicityAffects neurodevelopment
NoneLack of endurance, hypotonia, sullen expressionless
facies
NoneObstructive jaundice, dark urine
Signs of B12 deficiency
163
164165
166
167
168, 169
170
171-173
51
174
175
at the end of the tables in accordance with the 4th
Edition AMA Drug Evaluation. The reference list
is not inclusive of all articles published.
Physicians who encounter adverse effects in in-
fants fed breast milk due to exposure to drugs thatare not included here are urged to document the
effects in a communication to the Committee on
Drugs of the American Academy of Pediatrics in
Evanston. Such communication should include: the
generic and brand name of the drug; the maternal
dose and mode of administration; the concentrationof the drug in breast milk and maternal and infant
blood in relation to time of ingestion; the age of the
infant; and the method used for laboratory identi-fication. Such reports may significantly increase
the pediatric community’s fund of knowledge re-
garding drug transfer into breast milk and the
potential risk to the infant.
Drugs cited in Tables 1 to 4 are listed here by
category, in alphabetical order by generic name. For
convenience, one or more examples are also given.
ANESTHETICS, SEDATIVESmethyprylon-Noludar
secobarbital-Seconal, Seco-8
ANTICOAGULANTSbishydroxycoumarin-Dicumarol
0 phenindione-Hedulin, Eridionewarfarin-Coumadin, Panwarfin
ANTIEPILEPTICS
carbamazepine-Tegretolethosuximide-Zarontinphenytoin-Dilantinprimidone-Mysolinethiopental-Pentothalvalproic acid-Depakene
ANTIHISTAMINES, DECONGESTANTS, ANDBRONCHODILATORS
clemastine-Tavegil, Tavistdexbrompheniramine maleate with d-isoephedrine-Drix-
oral, Disophrol Chronotabdiphenhydramine-Benadryl, Benylin cough syrupdyphylline-Dilortheophylline-Theo-Dur, Elixophyllin, Slo-Phyllin, Bron-
kodyltrimeprazine tartrate-Temariltripelennamine-Pyribenzamine
ANTIHYPERTENSIVE AND CARDIOVASCULARAGENTS
atenolol-Tenormincaptopril-Capotendigoxin-Lanoxin, SK-Digoxindisopyramide-Norpaceguanethidine sulfate-Ismelinhydralazine-Apresolinemethyldopa-Aldometmetoprolol-Lopressornadolol-Corgardpropranolol-Inderalreserpine-Serpasil, Reserpoid, Hiserpia
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380 AGENTS TRANSFERRED INTO HUMAN BREAST MILK
ANTIINFECTIVE AGENTSamantadine-Symmetrelcefadroxil-Duricef
cefazolin-Ancef, Kefzolcefotaxime-Claforanchloramphenicol-Chloromycetinchloroquine-Aralenclindamycin-Cleocinethambutol-Myambutolisoniazid-INHmetronidazole-Flagylnalidixic acid-NegGramnitrofurantoin-Furadantin, Nitrofor, Macrodantinpyrimethainine-Daraprimquinine-Quinerifampin-Rifamycin, Rifadin, Rimactanesalicylazosulfapyridine-Azulfidinesulfisoxazole-Gantrisintetracycline-Achromycin, SK-Tetracyclinetrimethoprim with sulfamethoxazole-Bactrim, Septra,
Septra DS
ANTITHYROID AGENTScarbimazole-Neo-mercazolemethimazole-Tapazolepropylthiouracil-Propacilthiouracil-Thiouracil
CANCER CHEMOTHERAPY AGENTSamethopterin-Methotrexatecyclophosphamide-Cytoxan
CATHARTICSdanthron-Dorbane, Modane
DIAGNOSTIC AGENTSiopanoic acid-Telepaquemetrizamide-Amipaque
DIURETICSbendroflumethiazide-Naturetinchlorothiazide-Diuril, Chlotridechlorthalidone-Hygroton, Combipresmethyclothiazide-Aquatensen, Enduronspironolactone-Aldactone
HORMONESchlorotrianisene-TACEestradiol-Estrace3H-norethynodrel-Enovidprednisone-Deltasone, Meticorten, SK-Prednisone
MUSCLE RELAXANTSbaclofen-Lioresalcarisoprodol-Rela, Somamethocarbamal-Robaxin
NARCOTICS, NON -NARCOTIC ANALGESICS,ANTIINFLAMMATORY AGENTS
acetaminophen-Tylenol, Tylenol Extra Strength, Tern-pra, Phenaphen
butorphanol-Stadolflufenamic acid-Arlefgold sodium thiomalate-Myochrysineibuprofen-Motrinindomethacin-Indocinmefenamic acid-Ponstelmeperidine-Demerol, Pethadolmethadone-Westadonenaproxen-Naprosynphenylbutazone-Azolid, Butazolidin
prednisolone-Delta-Cortef, Steranepropoxyphene-Darvon, SK65, Dolene
PSYCHOTROPIC AGENTSamitriptyline-Elavil, Endepamoxapine-Asendinchlordiazepoxide-Librium, Libritabs, Menrium, SK-Ly-
genchlorpromazine-Thorazineclorazepate-Tranxenedesipramine-Norpramin, Pertofrane
diazepam-Valiumdichloralphenazone-Fenzal, Welldormdothiepin-Prothiadenhaloperidol-Haldolimipramine-Tofranil, SK-Pramine, Imavatemeprobamate-Equanil, Miltown, Meprospan, 5K-Ba-
matemesoridazine-Lidanaroxazepam-Seraxpiperacetazine-Quideprazepam-Centraxprochlorperazine-Compazine
thioridazine-Mellariltranylcypromine-Parnatetrifluoperazine-Stelazine
STIMULANTS
amphetamine (dexamphetamine sulfate)-Dexedrinebromocriptine-Parlodelergotamine tartrate with caffeine-Cafergot
MISCELLANEOUSacetamide-Colchicinebethanechol chloride-Urecholinecimetidine-Tagametdiphenoxylate with atropine-Lomotiltolbutamide-Orinase, SK-Tolbutamide
FOOD ADDITIVESmonosodium glutamate-MSGsaccharin-Sucaryl
COMMITTEE ON DRUGS, 1982-1983
Albert W. Pruitt, MD, Chairman
Walter R. Anyan, Jr, MD
Reba M. Hill, MDRalph E. Kauffman, MDHoward C. Mofenson, MD
Harvey S. Singer, MD
Stephen P. Spielberg, MD, PhD
Liaison Representatives
John C. Ballin, PhDCharlotte Catz, MD
Louis Farchione, MD
Martha M. Freeman, MD
Jennifer Niebyl, MD
Dorothy L. Smith, PharmD
Sam A. Licata, MD
Godfrey Oakley, MD
Steven Sawchuk, MS
Section Representatives
Earl J. Brewer, MD 0John A. Leer, MD
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AMERICAN ACADEMY OF PEDIATRICS 381
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