AMERICAN ACADEMY OF PEDIATRICS

1 AMERICAN ACADEMY OF PEDIATRICSC ommittee on DrugsThe Transfer of Drugs and Other Chemicals Into Human MilkABSTRACT. 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.

2 Nicotine, psychotropic drugs, and silicone im-plants are 3 important topics reviewed in this on the transfer of drugs and chem-icals into human milk was first published in1983,1with revisions in 19892and 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 AND SMOKINGIn the previous edition of this statement, the Com-mittee on Drugs placed nicotine (smoking) in Table2, Drugs of Abuse-Contraindicated During Breast-feeding.

3 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 12 There is controversy re-garding the effects of nicotine on infant size at 1 yearof ,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 ofcompounds and environmental exposure. Nicotine ispresent in milk in concentrations between and the simultaneous maternal plasma concentra-tion,15and elimination half-life is similar 60 to 90minutes in milk and is no evidence todocument whether this amount of nicotine presents ahealth risk to the nursing Committee on Drugs wishes to support theemphasis of the AMERICAN ACADEMY of PEDIATRICS onincreasing breastfeeding in the United States.

4 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 maybe that breastfeeding and smoking is less detrimentalto the child than bottle feeding and smoking. TheCommittee on Drugs awaits more data on this 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.

5 Al-ternate (oral, transcutaneous) sources of nicotine toassist with smoking cessation, however, have notbeen studied sufficiently for the Committee on Drugsto make a recommendation for or against them inbreastfeeding DRUGSAnti-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 ) in milk after maternal ingestion. Becauseof the long half-life of these compounds and some oftheir metabolites, nursing infants may have measur-able amounts in their plasma and tissues, such as thebrain. 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.

6 Because these drugs affectneurotransmitter function in the developing centralThe 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 (ISSN 0031 4005). Copyright 2001 by the AMERICAN Acad-emy of Vol. 108 No. 3 September 2001 by guest on June 28, from nervous system, it may not be possible to predictlong-term neurodevelopmental BREAST IMPLANTS ANDBREASTFEEDINGA pproximately 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 ,18 This finding has not been confirmed by other chemistry is extremely complex; the poly-mer involved in the covering and the interior of thebreast implant consists of a polymer of alternatingsilicon and oxygen atoms with methyl groups at-tached to the oxygen groups (methyl polydimethyl-siloxane).

7 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 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 unlikely that elemental silicon causes difficulty,because silicon is present in higher concentrations incow milk and formula than in milk of humans anticolic compound simethicone is asilicone and has a structure very similar to themethyl polydimethylsiloxane in breast has been used for decades in this coun-try and Europe without any evidence of toxicity toinfants.

8 The Committee on Drugs does not feel thatthe evidence currently justifies classifying siliconeimplants as a contraindication to THERAPY OF THE LACTATING WOMANThe 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 The safest drug should be chosen, for example,acetaminophen rather than aspirin for 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 Drug exposure to the nursing infant may be min-imized by having the mother take the medicationjust after she has breastfed the infant or just beforethe infant is due to have a lengthy sleep have been obtained from a search of themedical literature.

9 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 currentPhysicians Desk Reference,23 USP DI2001: Drug Information for the Health Care Professional,Volume I,24and USP Dictionary of USAN and Interna-tional Drug reference list is not inclusiveof all articles published on the 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 ( )and 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.

10 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 on Drugs, 2000 2001 Robert M. Ward, MD, ChairpersonBrian A. Bates, MDWilliam E. Benitz, MDDavid J. Burchfield, MDJohn C. Ring, MDRichard P. Walls, MD, PhDPhilip D. Walson, MDLiaisonsJohn 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, CanadaJoseph Mulinare, MD, MSPHC enters for Disease Control and PreventionLaura E. Riley, MDAmerican College of Obstetricians andGynecologistsSumner J.