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Downloaded84 No AMERICAN ACADEMY OF PEDIATRICS Committee on Drugs Transfer of Drugs and Other Chemicals Into Human Milk Since the first publication of this statement,’ ing and/or just before the infant has his or her much new information has been published concern- lengthy sleep periods. ing the transfer of drugs and chemicals into human Data have been obtained from a search of the milk. This information, in addition to other re- medical literature. Because methodologies used to search published before 1983, makes a revision of quantitate drugs in milk continue to improve, this the previous statement necessary. In this revision, current information will require continuous updat- lists of the pharmacologic or chemical agents trans- ing. Brand names are listed in Table 8 in accord- ferred into human milk and their possible effects ance with the current AMA Drug Evaluation, the on the infant or on lactation, if known, are provided USAN and USP Dktionarj of Drug Names. The (Tables 1 to 7). The fact that a pharmacologic or reference list is not inclusive of all articles pub- chemical agent does not appear in the Tables is not lished. meant to imply that it is not transferred into human Physicians who encounter adverse effects in in- milk or that it does not have an effect on the infant fants fed drug-contaminated human milk are urged 0 but indicates that there are no reports in the liter- to document these effects in a communication to ature. These tables should assist the physician in the AAP Committee on Drugs and the US Food counseling a nursing mother regarding breast-feed- and Drug Administration. Such communication ing when the mother has a condition for which a should include: the generic and brand name of the drug is medically indicated. drug, the maternal dose and mode of adininistra- The following questions should be considered tion, the concentration of the drug in milk and when prescribing drug therapy to lactating women. maternal and infant blood in relation to time of (1) Is the drug therapy really necessary? Consul- ingestion, the age of the infant, and the method tation between the pediatrician and th mother’s used for laboratory identification. Such reports may physician can be most useful. (2) Use the safest significantly increase the pediatric community’s drug; for example, acetaminophen rather than as- fund of knowledge regarding drug transfer into pirin for oral analgesia. (3) If there is a possibility human milk and the potential or actual risk to the that a drug may present a risk to the infant (eg, infant. phenytoin, phenobarbital), consideration should be given to measurement of blood concentrations in ACKNOWLEDGMENT the nursing infant. (4) Drug exposure to the nursing We thank Linda Harnden for her work in reference infant may be minimized by having the mother take identification, document retrival, and manuscript prepa- the medication just after completing a breast-feed- ration. Drugs cited in Tables 1 to 7 are listed in alphabetical order by generic name. The recommendations in this statement do not indicate an COMMIrFEE ON DRUGS, 1988-1989 exclusive course of treatment to be followed. Variations, taking Robert J. Roberts, MD, PhD, Chairman into account individual circumstances, may be appropriate. Jeffrey L. Blumer, MD Reprint requests to Publications Department, American Acad- Richard L. Gorman, MD emy of Pediatrics, 141 Northwest Point Blvd, P0 Box 927, Elk George H. Lambert, MD Grove Village, IL 60009-0927. 0 PEDIATRICS (ISSN 0031 4005). Copyright © 1989 by the Barry H. Rumack, MD American Academy of Pediatrics. Wayne Snodgrass, MD 924 PEDIATRICS Vol.Downloaded84 No. from 5 November www.aappublications.org/news 1989 by guest on September 27, 2021 Liaison Representatives lege of Obstetricians and Gynecolo- Donald R. Bennett, MD, PhD, American gists Medical Association Gloria Troendle, MD, Food and Drug Jose F. Cordero, MD, MPH, Centers for Administration 0 Disease Control Sumner J. Yaffe, MD, National Institute John C. Petricciani, MD, Pharmaceuti- of Child Health and Human Develop- cal Manufacturers’ Association ment Sam A. Licata, MD, National Health AAP Section Liaison and Welfare, Health Protection Cheston M. Berlin, MD, Section on Branch, Canada Clinical Pharmacology Mary Lund Mortensen, MD, Centers for Consultant Disease Control Ralph E. Kauffman, MD Martin L. Pernoll, MD, American Col- Anthony R. Temple, MD TABLE 1. Drugs That Are Contraindicated During Breast-Feeding Drug Reported Sign or Symptom in Infant or Effect on Lactation Reference No. Bromocriptine Suppresses lactation 2 Cocaine Cocaine intoxication 3 Cyclophosphamide Possible immune suppression; unknown effect on growth or association 4,5 with carcinogenesis; neutropenia Cyclosporine Possible immune suppression; unknown effect on growth or association 6 with carcinogenesis Doxorubicin* Possible immune suppression; unknown effect on growth or association 7 with carcinogenesis 0 Ergotamine Vomiting, diarrhea, convulsions (doses used in migraine medications) 8 Lithium 1/3 to 1/2 therapeutic blood concentration in infants 9-11 Methotrexate Possible immune suppression; unknown effect on growth or association 12 with carcinogenesis; neutropenia Phencycidine (PCP) Potent hallucinogen 13 Phenindione Anticoagulant; increased prothrombin and partial thromboplastin time in 14 1 infant (not used in USA) * Drug is concentrated in human milk. TABLE 2. Drugs of Abuse That Are Contraindicated During Breast-Feedings Reference Drug Effect No. Amphetamine Irritability, poor sleep pattern 15 Cocaine Cocaine intoxication 3 Heroin 16 Marijuana Only one report in literature; no effect mentioned 17 Nicotine (smoking) Shock, vomiting, diarrhea, rapid heart rate, restlessness; 18-20 decreased milk production Phencyclidine Potent hallucinogen 13 * The Committee on Drugs believes strongly that nursing mothers should not ingest any of these compounds. Not only are they hazardous to the nursing infant but they are detrimental to the physical and emotional health of the 0 mother. t Drug is concentrated in human milk. Downloaded from www.aappublications.org/newsAMERICAN by guest on ACADEMY September 27, 2021 OF PEDIATRICS 925 TABLE 3. Radiopharmaceuticals That Require Temporary Cessation of BreastFeeding* ... Reference Drug Recommended Alteration in Breast-Feeding Pattern No. Gallium-67 (67Ga) Radioactivity in milk present for 2 wk 21 Indium-ill (“In) Small amount present at 20 h 22 Iodine-125 (1251) Risk of thyroid cancer; radioactivity in milk pres- 23 0 ent for 12 d Iodine-131 (131J) Radioactivity in milk present 2-14 d depending on 24-27 study Radioactive sodium Radioactivity in milk present 96 h 28 Technetium-99m (“Tc), ‘Tc macroaggregates, Radioactivity in milk present 15 h to 3 d 29-34 TcO4 * Consult nuclear medicine physician before performing diagnostic study so that a radionuclide with the shortest excretion time in breast milk can be used. Before study, the mother should pump her breast and store enough milk in freezer for feeding the infant; after study, the mother should pump her breast to maintain milk production but discard all milk pumped for the required time that radioactivity is present in milk. TABLE 4. Drugs Whose Effect on Nursing Infants Is Unknown but May Be of Concern Drug Effect Reference No. Psychotropic Special concern when given to nursing mothers for long 35 drugs periods of time Antianxiety Diazepam None 36, 37 Lorazepam None 38 Prazepam* None 39 Quazepam None 40 Antidepressant Amitriptyline None 41, 42 Amoxapine None 43 Desipramine None 44,45 Dothiepin None 46 Doxepin None 47 Imipramine None 44 Trazodone None 48 0 Antipsychotic Chlor- Galactorrhea in adult; drowsiness and lethargy in infant 49, 50 promazine Chiorpro- None 51 thixene Haloperidol None 52, 53 Mesoridazine None 54 Chioramphenicol Possible idiosyncratic bone marrow suppression 55, 56 Metoclopram- None described potent central nervous system drug 57,58 ide*K Metronidazole In vitro mutagen; may discontinue breast-feeding 12-24 59, 60 h to allow excretion of dose when single-dose therapy given to mother Tinidazole See Metronidazole 61 * Drug is concentrated in human milk. TABLE 5. Drugs That Have Caused Significant Effects on Some Nursing Infants and Should Be Given to Nursing Mothers With Caution* Reference Drug Effect No. Aspirin (salicylates) Metabolic acidosis (dose related); may affect 62-64 platelet function; rash Clemastine Drowsiness, irritability, refusal to feed, high- 65 pitched cry, neck stiffness (1 case) Phenobarbital Sedation; infantile spasms after weaning from 66-70 milk containing phenobarbital, methemo- globinemia (1 case) Primidone Sedation, feeding problems 66, 67 Salicylazosulfapyridine (sulfasalazine) Bloody diarrhea in 1 infant 71 0 * Measure blood concentration in the infant when possible. 926 DRUG AND CHEMICALDownloaded from TRANSFER www.aappublications.org/news by guest on September 27, 2021 TABLE 6. Maternal Medication Usually Compatible With Breast-Feedings Drug Reported Sign or Symptom in Infant or Effect on Lactation Reference No. Anesthetics, Sedatives Alcohol Drowsiness, diaphoresis, deep sleep, weakness, decrease 18, 72-74 0 in linear growth, abnormal weight gain; maternal ingestion of 1 g/kg daily decreases milk ejection reflex Barbiturate See TableS Bromide Rash, weakness, absence of cry with maternal intake of 75 5.4 g/d Chloral hydrate Sleepiness 76 Chloroform None 77 Halothane None 78 Lidocaine None 79 Magnesium sulfate None 80 Methyprylon Drowsiness 81 Secobarbital None 82 Thiopental None 83 Anticoagulants Bishydroxycoumarin None 84 Warfarin
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