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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. , 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 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 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 ) 8 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 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 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 None 38 Prazepam* None 39 Quazepam None 40 Antidepressant None 41, 42 None 43 None 44,45 Dothiepin None 46 None 47 None 44 Trazodone None 48 0 Chlor- Galactorrhea in adult; drowsiness and lethargy in infant 49, 50 Chiorpro- None 51 thixene None 52, 53 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. (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) 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 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 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 None 79 sulfate None 80 Methyprylon Drowsiness 81 Secobarbital None 82 Thiopental None 83 Anticoagulants Bishydroxycoumarin None 84 Warfarin None 85 Antiepileptics None 86,87 None; drug appears in infant serum 86,88 Phenobarbital See Table 5 66-70, 86 Phenytoin Methemoglobinemia (1 case) 68, 86, 89 Primidone See TableS 66, 67, 86 Thiopental None 69,83 Valproic acid None 86, 90, 91 , deconges- tants, and bronchodila- tore DexbromDheniramine ma- Crying, poor sleep patterns, irritability 92 leate with d-isoephed- nine 0 Dyphyllinet None 93 lodides May affect thyroid activity; see Miscellaneous, iodine 94 Pseudoephedrinet None 95 Terbutaline None 96 Theophylline Irritability 97, 98 Triprolidine None 95 Antihypertensive and cardio- vascular drugs None 99 None 100 Captopril None 101 None 102, 103 None 104 None 105, 106 None 107 Labetalol None 108 Lidocaine None 79 Methyldopa None 109 Metoprololt None 100 None 110 None 111 Nadololt None 112 Oxprenolol None 113, 114 None 115 None 116-118 None 119 Timolol None 114 None 120 Antlinfective drugs (all anti- 121 biotics transfer into 0 breast milk in limited amounts)

Downloaded from www.aappublications.org/newsAMERICAN by guest on ACADEMY September 27, OF2021 PEDIATRICS 927 TABLE 6.-Continued

Drug Reported Sign or Symptom in Infant or Effect on Lactation Reference No. Acyclovirt None 122 Amoxicillin None 123 Aztreonam None 124 Cefadroxil None 123 Cefazolin None 125 Cefotaxime None 126 Cefoxitin None 126 Ceftazidine None 127 Ceftriaxone None 128 Chloroquine None 129-131 Clindamycin None 132 Cycloserine None 133 Dapsone None; sulfonamide detected in infant’s urine 131, 134 Erythromycint None 121 Ethambutol None 133 Hydroxychloroquinet None 135, 136 Isoniazid None. acetyl metabolite also secreted ? hepatoxicity 133, 137 Kanamycin None 133 Moxalactam None 138 Nalidixic acid Hemolysis in infant with glucose--6-phosphate defi- 139 ciency (G-6-PD) Nitrofurantoin Hemolysis in infant with G-6-PD 140 Pyrimethamine None 131, 141 Quinine None 142 Rifampin None 133 Salicylazosulfapyridine See Table 5 71, 143, 144 (sulfasalazine) Streptomycin None 133 Sulbactam None 145 Sulfapyridine Caution in infant with jaundice or G-6-PD, and in ill, 143, 144 stressed, or premature infant. Appears in infant’s o urine. Sulfisoxazole Caution in infant with jaundice or G-6-PD, and in ill, 146 stressed, or premature infant. Appears in infant’s urine Tetracycline None; negligible absorption by infant 147, 148 Ticardillin None 149 Trimethoprim/sulfameth- None 150, 151 oxazole Antithyroid drugs Carbimazole Goiter 152 Methimazole (active me- None 153 tabolite of carbimazole) Propylthiouracil None 154 Thiouracil None mentioned; drug not used in USA 155 Cathartics 156, 157 Cascara None 157 Danthron Increased bowel activity 158 Senna None 159 Diagnostic agents Iodine Goiter; see Miscellaneous, iodine 94 lopanoic acid None 160 Metrizamide None 161 Diuretic agents Bendroflumethiazide Suppresses lactation 162 Chiorothiazide, hydrochlo- None 163, 164 rothiazide Chlorthalidone Excreted slowly 165 None 166 Hormones 3H-norethynodrel None 167 19-norsteroids None 168 Q Clogestone None 169 Contraceptive pill with es- Rare breast enlargement; decrease in milk production 170-177

928 DRUG AND CHEMICALDownloaded from TRANSFER www.aappublications.org/news by guest on September 27, 2021 TABLE 6.-Continued Reference Drug Reported Sign or Symptom in Infant or Effect on Lactation No.

trogen/progesterone and protein content (not confirmed in several 0 studies) Withdrawal, vaginal bleeding 178 Medroxyprogesterone None 169 Prednisolone None 179 Prednisone None 180 Progesterone None 181 Muscle relaxants None 182 None 183 Narcotics, nonnarcotic an- algesics, anti-inflamma- tory agents Acetaminophen None 184-186 None 187 None 186,188 Dipyrone None 189 Flufenainic acid None 190 Gold salts None 191-194 Hydroxychioroquine None 135, 136 None 195, 196 Indomethacin Seizure (1 case) 197, 198 None 199 None if mother receiving 20 mg/24 h 200, 201 None 142 None 202 Phenylbutazone None 203 None 204 Prednisolone, prednisone None 179, 180 Propoxyphene None 205 Salicylates See Table 5 62-64 None 206 0 None 207 Stimulants Caffeine Irritability, poor sleep pattern, excreted s1owly, no ef- 98, 208-212 fect with usual amount of caffeine beverages Vitamins B, (thiamin) None 213 B6 (pyridoxine) None 214-216 B,2 None 217 D None; follow infant’s serum calcium if mother receives 218-220 pharmacologic doses Folic acid None 221 K1 None 222, 223 Riboflavin None 213 Miscellaneous Acetazolamide None 224 , None 188 Cimetidinet None 226 None 225 Cisplatin Not found in milk 7 None 227 Iodine (povidone-iodine/ Elevated iodine levels in breast milk, odor of iodine on 94 vaginal douche) infant’s skin See Table 4 57,58 Noscapine None 228 Pyridostigmine None 229 ? Jaundice 230 * Drugs listed have been reported in the literature as having the effects listed or no effect. The word “none” means that no observable change was seen in the nursing infant while the mother was ingesting the compound. It is emphasized that most of the literature citations concern single case reports or small series of infants. 0 Drug is concentrated in human milk.

Downloaded from www.aappublications.org/newsAMERICAN by guest on ACADEMYSeptember 27, 2021 OF PEDIATRICS 929 TABLE 7. Food and Environmental Agents and Their Effect on Breast-Feeding Reported Sign or Symptom in Infant or Effect on Reference A e tgn Lactation No. Aflatoxin None 231 Aspartame Caution if mother or infant has phenylketonuria 232 0 Bromide (photographic laboratory) Potential absorption and bromide transfer into 233 milk; see Table 6, Anesthetics, sedatives Cadmium None reported 234 Chlordane None reported 235 Chocolate (theobromine) Irritability or increased bowel activity if excess 98, 236 amounts (16 oz/d) consumed by mother DDT, benzenehexachlorides, dieldrin, aldrin, he- None 237, 243 patachlorepoxide Fava beans Hemolysis in patient with glucose-6-phosphate de- 244 ficiency (G-6-PD) Fluorides None 245, 246 Hexachlorobenzene Skin rash, diarrhea, vomiting, dark urine, neurotox- 247, 248 icity, death Hexachiorophene None; possible contamination of milk from nipple 249 washing Lead Possible neurotoxicity 250, 251 Methyl mercury, mercury May affect neurodevelopment 252-254 Monosodium glutamate (MSG) None 255 Polychiorinated biphenyls and polybrominated Lack of endurance, hypotoma, sullen expressionless 256-260 biphenyls facies Tetrachlorethylene-cleaning fluid (perchloro- Obstructive jaundice, dark urine 261 ethylene) Vegetarian diet Signs of B,2 deficiency 262

TABLE 8. Trade Names of Generic Drugs*

Generic Trade Generic Trade 0 acebutolol Sectral cisapride acetaminophen , Tylenol Extra cisplatin Platinol Strength, Tempra, clemastine Tavegil, Tavist Phenaphen clindamycin Cleocin acetazolamide Diamox cyclophosphamide Cytoxan amitriptyline Elavil, Endep cycloserine Seromycin amoxapine Asendin danthron Dorbane, Modane amoxicillin Amoxyl dapsone amphetamine Dexedrine desipramine Norpramin, Pertofrane (dexamphetamin) dexbrompheniramine Drixoral, Disophrol, aspartame Nutrasweet maleate with Chronotab atenolol Tenormin d-isoephedrine aztreonam Azactam diazepam Valium baclofen Lioresal dicuinarol bendroflumethiazide Naturetin digoxin Lanoxin, SK-Digoxin bromocriptine Parlodel diltiazem Cardizem butorphanol Stadol dipyrone Novaldin captopril Capoten disopyramide Norpace carbamazepine Tegretol domperidone carbimazole Neo-mercazole dothiepin Prothiaden cefadroxil Duricef doxepin Adapin, Sinequan cefazolin Ancef, Kefzol doxorubicin Adriamycin cefotaxime Claforan dyphylline Dior ceftazidime Fortaz ergotamine tartrate with Cafergot ceftriaxone Rocephin caffeine chioramphenicol Chloromycetin estradiol Estrace chloroquine Aralen ethambutol Myambutol chiorothiazide Diuril, Chlotride ethosuximide Zarontin chiorpromazine Thorazine Arlef chiorprothixene Taractan gold sodium thiomalate Myochrysine 0 chlorthalidone Hygroton, Combipres haloperidol Haldol cimetidine Tagamet hydralazine Apresoline

930 DRUG AND CHEMICALDownloaded fromTRANSFER www.aappublications.org/news by guest on September 27, 2021 TABLE 8.-Continued Generic Trade Generic Trade hydrochlorothiazide Hydrodiuril prazepam Centrax prednisolone Delta-Cortef, Sterane 0 hydroxychioroquine Plaquenil ibuprofen Motrin prednisone Deltasone, Meticorten, imipramine Tofranil, SK-Pramine, SK-Prednisone Imavate primidone Mysoline indomethacin Indocin procainamide Pronestyl iopanoic acid Telepaque propoxyphene Darvon, SK65, Dolene isoniazid INH propranolol Inderal kanamycin Kantrex propylthiouracil Propacil labetalol Normodyne, Trandate pseudoephedrine Actifed lidocaine Xylocaine pyrimethamine Daraprim lorazepam Ativan pyridostigmine Mestinon Provera quazepam Dormalin mefenamic acid Ponstel quinine Quine mesoridazine Lidanar rifampin Rifamycin, Rifadin, Ri- methadone Westadone mactane methimazole Tapazole salicylazosulfapyridine Azulfidine methocarbamol Robaxin secobarbital Seconal, Seco-8 methotrexate (amethop- Folex senna Senokot term) spironolactone Aldactone methyprylon Noludar sulbactam Unasyn metoclopramide Reglan sulfisoxazole Gantrisin Lopressor suprofen Suprol metrizamide Amipaque terbutaline Bricanyl, Brethine metronida.zole Flagyl tetracycline Achromycin, SK-Tetra- mexiletine Mexitil cycline minoxidil Loniten theophyffine Theo-Dur, Elixophyllin, monosodium glutamate MSG, Accent, Adolph’s Slo-Phyllin, Bronkodyl Meat Tenderizer thiopental Pentothal moxalactam Moxam thiouracil Thiouradil Corgard ticarcillin Timentin nalidixic acid NegGram timolol Blocadren, Timoptic 0 nefopam Acupan tolbutamide Orinase, SK-Tolbuta- nitrofurantoin Furadantin, Nitrofor, mide Macrodantin tolmetin Tolectin 3H-norethynodrel Envoid trazodone Desyrel noscapine Tusscapine trimethoprim with sulfa- Bactrim, Septra, Septra oxprenolol methoxazole DS phenindione Hedulin, Eridione triprolidine Actifed phenylbutazone Azolid, Butazolidin vaiproic acid Depakene phenytoin Dilantin verapamil Calan piroxicam Feldene warfarmn Coumadin, Panwarfm * For convenience, one or more examples of the trade name are given.

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