Pediatrics 2001 776 89 Drugs Contraindicated in Breastfeeding

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   2001;108;776 Pediatrics Committee on Drugs The Transfer of Drugs and Other Chemicals Into Human Milk located on the World Wide Web at: The online version of this article, along with updated information and services, is   of Pediatrics. All rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.Boulevard, Elk Grove Village, Illinois, 60007. Copyright © 2001 by the American Academy published, and trademarked by the American Academy of Pediatrics, 141 Northwest Pointpublication, it has been published continuously since 1948. PEDIATRICS is owned, PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly  at Philippines:AAP Sponsored on October 9, 2014pediatrics.aappublications.orgDownloaded from at Philippines:AAP Sponsored on October 9, 2014pediatrics.aappublications.orgDownloaded from at Philippines:AAP Sponsored on October 9, 2014pediatrics.aappublications.orgDownloaded from at Philippines:AAP Sponsored on October 9, 2014pediatrics.aappublications.orgDownloaded from at Philippines:AAP Sponsored on October 9, 2014pediatrics.aappublications.orgDownloaded from at Philippines:AAP Sponsored on October 9, 2014pediatrics.aappublications.orgDownloaded from at Philippines:AAP Sponsored on October 9, 2014pediatrics.aappublications.orgDownloaded from  AMERICAN ACADEMY OF PEDIATRICS Committee on Drugs The Transfer of Drugs and Other Chemicals Into Human Milk ABSTRACT. The American Academy of Pediatricsplaces emphasis on increasing breastfeeding in theUnited States. A common reason for the cessation ofbreastfeeding is the use of medication by the nursingmother and advice by her physician to stop nursing. Suchadvice may not be warranted. This statement is intendedto supply the pediatrician, obstetrician, and family phy-sician with data, if known, concerning the excretion ofdrugs into human milk. Most drugs likely to be pre-scribed to the nursing mother should have no effect onmilk supply or on infant well-being. This information isimportant not only to protect nursing infants from unto-ward effects of maternal medication but also to alloweffective pharmacologic treatment of breastfeedingmothers. Nicotine, psychotropic drugs, and silicone im-plants are 3 important topics reviewed in this statement.INTRODUCTION A statement on the transfer of drugs and chem-icals into human milk was first published in1983, 1 with revisions in 1989 2 and 1994. 3 In-formation continues to become available. The currentstatement is intended to revise the lists of agentstransferred into human milk and describe their pos-sible effects on the infant or on lactation, if known(Tables 1–7). If a pharmacologic or chemical agentdoes not appear in the tables, it does not mean that itis not transferred into human milk or that it does nothave an effect on the infant; it only indicates thatthere were no reports found in the literature. Thesetables should assist the physician in counseling anursing mother regarding breastfeeding when themother has a condition for which a drug is medicallyindicated. BREASTFEEDING AND SMOKING In the previous edition of this statement, the Com-mittee on Drugs placed nicotine (smoking) in Table2, “Drugs of Abuse-Contraindicated During Breast-feeding.” The reasons for placing nicotine and, thus,smoking in Table 2 were documented decrease inmilk production and weight gain in the infant of thesmoking mother and exposure of the infant to envi-ronmental tobacco smoke as demonstrated by thepresence of nicotine and its primary metabolite, co-tinine, in human milk. 4–12 There is controversy re-garding the effects of nicotine on infant size at 1 yearof age. 13,14 There are hundreds of compounds intobacco smoke; however, nicotine and its metaboliteacotinine are most often used as markers of tobaccoexposure. Nicotine is not necessarily the only com-ponent that might cause an increase in respiratoryillnesses (including otitis media) in the nursing in-fant attributable to both transmammary secretion of compounds and environmental exposure. Nicotine ispresent in milk in concentrations between 1.5 and 3.0times the simultaneous maternal plasma concentra-tion, 15 and elimination half-life is similar—60 to 90minutes in milk and plasma. 7 There is no evidence todocument whether this amount of nicotine presents ahealth risk to the nursing infant.The Committee on Drugs wishes to support theemphasis of the American Academy of Pediatrics onincreasing breastfeeding in the United States. Preg-nancy and lactation are ideal occasions for physi-cians to urge cessation of smoking. It is recognizedthat there are women who are unable to stop smok-ing cigarettes. One study reported that, amongwomen who continue to smoke throughout breast-feeding, the incidence of acute respiratory illness isdecreased among their infants, compared with in-fants of smoking mothers who are bottle fed. 16 It may be that breastfeeding and smoking is less detrimentalto the child than bottle feeding and smoking. TheCommittee on Drugs awaits more data on this issue.The Committee on Drugs therefore has not placednicotine (and thus smoking) in any of the Tables buthopes that the interest in breastfeeding by a smokingwoman will serve as a point of discussion aboutsmoking cessation between the pediatrician and theprospective lactating woman or nursing mother. Al-ternate (oral, transcutaneous) sources of nicotine toassist with smoking cessation, however, have not been studied sufficiently for the Committee on Drugsto make a recommendation for or against them in breastfeeding women. PSYCHOTROPIC DRUGS Anti-anxiety drugs, antidepressants, and neuro-leptic drugs have been placed in Table 4, “Drugs forWhich the Effect on Nursing Infants is Unknown butMay Be of Concern.” These drugs appear in lowconcentrations (usually with a milk-to-plasma ratioof 0.5–1.0) in milk after maternal ingestion. Becauseof the long half-life of these compounds and some of their metabolites, nursing infants may have measur-able amounts in their plasma and tissues, such as the brain. This is particularly important in infants duringthe first few months of life, with immature hepaticand renal function. Nursing mothers should be in-formed that if they take one of these drugs, the infantwill be exposed to it. Because these drugs affectneurotransmitter function in the developing central The recommendations in this statement do not indicate an exclusive courseof treatment or serve as a standard of medical care. Variations, taking intoaccount individual circumstances, may be appropriate.PEDIATRICS (ISSN 0031 4005). Copyright © 2001 by the American Acad-emy of Pediatrics. 776  PEDIATRICS Vol. 108 No. 3 September 2001  at Philippines:AAP Sponsored on October 9, 2014pediatrics.aappublications.orgDownloaded from  nervous system, it may not be possible to predictlong-term neurodevelopmental effects. SILICONE BREAST IMPLANTS ANDBREASTFEEDING Approximately 800 000 to 1 million women in theUnited States have received breast implants contain-ing silicone (elemental silicon with chemical bonds tooxygen) in the implant envelope or in the envelopeand the interior gel. Concern has been raised aboutthe possible effects to the nursing infant if motherswith implants breastfeed. This concern was initiallyraised in reports that described esophageal dysfunc-tion in 11 children whose mothers had implants. 17,18 This finding has not been confirmed by other reports.Silicone chemistry is extremely complex; the poly-mer involved in the covering and the interior of the breast implant consists of a polymer of alternatingsilicon and oxygen atoms with methyl groups at-tached to the oxygen groups (methyl polydimethyl-siloxane). 19 The length of the polymer determineswhether it is a solid, gel, or liquid. There are only afew instances of the polymer being assayed in themilk of women with implants; the concentrations arenot elevated over control samples. 20 There is no ev-idence at the present time that this polymer is di-rectly toxic to human tissues; however, concern alsoexists that toxicity may be mediated through an im-munologic mechanism. This has yet to be confirmedin humans. Except for the study cited above, therehave been no other reports of clinical problems ininfants of mothers with silicone breast implants. 21 Itis unlikely that elemental silicon causes difficulty, because silicon is present in higher concentrations incow milk and formula than in milk of humans withimplants. 22 The anticolic compound simethicone is asilicone and has a structure very similar to themethyl polydimethylsiloxane in breast implants.Simethicone has been used for decades in this coun-try and Europe without any evidence of toxicity toinfants. The Committee on Drugs does not feel thatthe evidence currently justifies classifying siliconeimplants as a contraindication to breastfeeding. DRUG THERAPY OF THE LACTATING WOMAN The following should be considered before pre-scribing drugs to lactating women:1. Is drug therapy really necessary? If drugs arerequired, consultation between the pediatricianand the mother’s physician can be most useful indetermining what options to choose.2. The safest drug should be chosen, for example,acetaminophen rather than aspirin for analgesia.3. If there is a possibility that a drug may present arisk to the infant, consideration should be given tomeasurement of blood concentrations in the nurs-ing infant.4. Drug exposure to the nursing infant may be min-imized by having the mother take the medication just after she has breastfed the infant or just beforethe infant is due to have a lengthy sleep period.Data have been obtained from a search of themedical literature. Because methodologies used toquantitate drugs in milk continue to improve, thisinformation will require frequent updating. Drugscited in Tables 1 through 7 are listed in alphabeticalorder by generic name; brand names are availablefrom the current  Physicians’ Desk Reference , 23 USP DI 2001: Drug Information for the Health Care Professional,Volume I, 24 and USP Dictionary of USAN and Interna-tional Drug Names . 25 The reference list is not inclusiveof all articles published on the topic.Physicians who encounter adverse effects in in-fants who have been receiving drug-contaminatedhuman milk are urged to document these effects in acommunication to the Food and Drug Administra-tion ( to the Committee on Drugs. This communicationshould include the generic and brand names of thedrug, the maternal dose and mode of administration,the concentration of the drug in milk and maternaland infant blood in relation to the time of ingestion,the method used for laboratory identification, theage of the infant, and the adverse effects. Such re-ports may substantially increase the pediatric com-munity’s fund of knowledge regarding drug transferinto human milk and the potential or actual risk tothe infant. Committee on Drugs, 2000–2001 Robert M. Ward, MD, ChairpersonBrian A. Bates, MDWilliam E. Benitz, MDDavid J. Burchfield, MD John C. Ring, MDRichard P. Walls, MD, PhDPhilip D. Walson, MD Liaisons  John Alexander, MDFood and Drug Administration AlternateDonald R. Bennett, MD, PhDAmerican Medical Association/United StatesPharmacopeiaTherese Cvetkovich, MDFood and Drug AdministrationOwen R. Hagino, MDAmerican Academy of Child and AdolescentPsychiatryStuart M. MacLeod, MD, PhDCanadian Paediatric SocietySiddika Mithani, MDBureau of Pharmaceutical Assessment HealthProtection Branch, Canada Joseph Mulinare, MD, MSPHCenters for Disease Control and PreventionLaura E. Riley, MDAmerican College of Obstetricians andGynecologistsSumner J. Yaffe, MDNational Institutes of Health Section Liaisons Charles J. Cote´, MDSection on AnesthesiologyEli O. Meltzer, MDSection on Allergy and Immunology Consultant Cheston M. Berlin, Jr, MD Staff Raymond J. Koteras, MHAAMERICAN ACADEMY OF PEDIATRICS  777  at Philippines:AAP Sponsored on October 9, 2014pediatrics.aappublications.orgDownloaded from  TABLE 1.  Cytotoxic Drugs That May Interfere With Cellular Metabolism of the Nursing InfantDrug Reason for Concern, Reported Sign or Symptom in Infant, orEffect on LactationReference No.Cyclophosphamide Possible immune suppression; unknown effect on growth orassociation with carcinogenesis; neutropenia26, 27Cyclosporine Possible immune suppression; unknown effect on growth orassociation with carcinogenesis28, 29Doxorubicin* Possible immune suppression; unknown effect on growth orassociation with carcinogenesis30Methotrexate Possible immune suppression; unknown effect on growth orassociation with carcinogenesis; neutropenia31* Drug is concentrated in human milk. TABLE 2.  Drugs of Abuse for Which Adverse Effects on the Infant During Breastfeeding Have Been Reported*Drug Reported Effect or Reasons for Concern Reference No.Amphetamine† Irritability, poor sleeping pattern 32Cocaine Cocaine intoxication: irritability, vomiting, diarrhea,tremulousness, seizures33Heroin Tremors, restlessness, vomiting, poor feeding 34Marijuana Only 1 report in literature; no effect mentioned; very longhalf-life for some components35Phencyclidine Potent hallucinogen 36* The Committee on Drugs strongly believes that nursing mothers should not ingest drugs of abuse, because they are hazardous to thenursing infant and to the health of the mother.† Drug is concentrated in human milk. TABLE 3.  Radioactive Compounds That Require Temporary Cessation of Breastfeeding*Compound Recommended Time for Cessation of Breastfeeding Reference No.Copper 64 ( 64 Cu) Radioactivity in milk present at 50 h 37Gallium 67 ( 67 Ga) Radioactivity in milk present for 2 wk 38Indium 111 ( 111 In) Very small amount present at 20 h 39Iodine 123 ( 123 I) Radioactivity in milk present up to 36 h 40, 41Iodine 125 ( 125 I) Radioactivity in milk present for 12 d 42Iodine 131 ( 131 I) Radioactivity in milk present 2–14 d, depending on study 43–46Iodine 131 If used for treatment of thyroid cancer, high radioactivitymay prolong exposure to infant47, 48Radioactive sodium Radioactivity in milk present 96 h 49Technetium 99m ( 99m Tc),  99m Tcmacroaggregates,  99m Tc O 4 Radioactivity in milk present 15 h to 3 d 41, 50–55* Consult nuclear medicine physician before performing diagnostic study so that radionuclide that has the shortest excretion time in breastmilk can be used. Before study, the mother should pump her breast and store enough milk in the 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 ispresent in milk. Milk samples can be screened by radiology departments for radioactivity before resumption of nursing. 778  THE TRANSFER OF DRUGS AND OTHER CHEMICALS INTO HUMAN MILK  at Philippines:AAP Sponsored on October 9, 2014pediatrics.aappublications.orgDownloaded from

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