AMERICAN ACADEMY of PEDIATRICS the Transfer of Drugs

AMERICAN ACADEMY OF PEDIATRICS Committee on Drugs The Transfer of Drugs and Other Chemicals Into Human Milk ABSTRACT. The American Academy of Pediatrics exposure. Nicotine is not necessarily the only com- places emphasis on increasing breastfeeding in the ponent that might cause an increase in respiratory United States. A common reason for the cessation of illnesses (including otitis media) in the nursing in- breastfeeding is the use of medication by the nursing fant attributable to both transmammary secretion of mother and advice by her physician to stop nursing. Such compounds and environmental exposure. Nicotine is advice may not be warranted. This statement is intended to supply the pediatrician, obstetrician, and family phy- present in milk in concentrations between 1.5 and 3.0 sician with data, if known, concerning the excretion of times the simultaneous maternal plasma concentra- 15 drugs into human milk. Most drugs likely to be pre- tion, and elimination half-life is similar—60 to 90 scribed to the nursing mother should have no effect on minutes in milk and plasma.7 There is no evidence to milk supply or on infant well-being. This information is document whether this amount of nicotine presents a important not only to protect nursing infants from unto- health risk to the nursing infant. ward effects of maternal medication but also to allow The Committee on Drugs wishes to support the effective pharmacologic treatment of breastfeeding emphasis of the American Academy of Pediatrics on mothers. Nicotine, psychotropic drugs, and silicone im- increasing breastfeeding in the United States. Preg- plants are 3 important topics reviewed in this statement. nancy and lactation are ideal occasions for physi- INTRODUCTION cians to urge cessation of smoking. It is recognized that there are women who are unable to stop smok- statement on the transfer of drugs and chem- ing cigarettes. One study reported that, among icals into human milk was first published in women who continue to smoke throughout breast- 1983,1 with revisions in 19892 and 1994.3 In- A feeding, the incidence of acute respiratory illness is formation continues to become available. The current decreased among their infants, compared with in- statement is intended to revise the lists of agents fants of smoking mothers who are bottle fed.16 It may transferred into human milk and describe their pos- be that breastfeeding and smoking is less detrimental sible effects on the infant or on lactation, if known (Tables 1–7). If a pharmacologic or chemical agent to the child than bottle feeding and smoking. The does not appear in the tables, it does not mean that it Committee on Drugs awaits more data on this issue. is not transferred into human milk or that it does not The Committee on Drugs therefore has not placed have an effect on the infant; it only indicates that nicotine (and thus smoking) in any of the Tables but there were no reports found in the literature. These hopes that the interest in breastfeeding by a smoking tables should assist the physician in counseling a woman will serve as a point of discussion about nursing mother regarding breastfeeding when the smoking cessation between the pediatrician and the mother has a condition for which a drug is medically prospective lactating woman or nursing mother. Al- indicated. ternate (oral, transcutaneous) sources of nicotine to assist with smoking cessation, however, have not BREASTFEEDING AND SMOKING been studied sufficiently for the Committee on Drugs In the previous edition of this statement, the Com- to make a recommendation for or against them in mittee on Drugs placed nicotine (smoking) in Table breastfeeding women. 2, “Drugs of Abuse-Contraindicated During Breast- feeding.” The reasons for placing nicotine and, thus, PSYCHOTROPIC DRUGS smoking in Table 2 were documented decrease in Anti-anxiety drugs, antidepressants, and neuro- milk production and weight gain in the infant of the leptic drugs have been placed in Table 4, “Drugs for smoking mother and exposure of the infant to envi- Which the Effect on Nursing Infants is Unknown but ronmental tobacco smoke as demonstrated by the May Be of Concern.” These drugs appear in low presence of nicotine and its primary metabolite, co- 4–12 concentrations (usually with a milk-to-plasma ratio tinine, in human milk. There is controversy re- of 0.5–1.0) in milk after maternal ingestion. Because garding the effects of nicotine on infant size at 1 year 13,14 of the long half-life of these compounds and some of of age. There are hundreds of compounds in their metabolites, nursing infants may have measur- tobacco smoke; however, nicotine and its metabolite able amounts in their plasma and tissues, such as the acotinine are most often used as markers of tobacco brain. This is particularly important in infants during the first few months of life, with immature hepatic The recommendations in this statement do not indicate an exclusive course and renal function. Nursing mothers should be in- of treatment or serve as a standard of medical care. Variations, taking into account individual circumstances, may be appropriate. formed that if they take one of these drugs, the infant PEDIATRICS (ISSN 0031 4005). Copyright © 2001 by the American Acad- will be exposed to it. Because these drugs affect emy of Pediatrics. neurotransmitter function in the developing central 776 PEDIATRICS Vol.Downloaded 108 No. 3from September www.aappublications.org/news 2001 by guest on September 24, 2021 nervous system, it may not be possible to predict quantitate drugs in milk continue to improve, this long-term neurodevelopmental effects. information will require frequent updating. Drugs cited in Tables 1 through 7 are listed in alphabetical SILICONE BREAST IMPLANTS AND order by generic name; brand names are available BREASTFEEDING from the current Physicians’ Desk Reference,23 USP DI Approximately 800 000 to 1 million women in the 2001: Drug Information for the Health Care Professional, United States have received breast implants contain- Volume I,24 and USP Dictionary of USAN and Interna- ing silicone (elemental silicon with chemical bonds to tional Drug Names.25 The reference list is not inclusive oxygen) in the implant envelope or in the envelope of all articles published on the topic. and the interior gel. Concern has been raised about Physicians who encounter adverse effects in in- the possible effects to the nursing infant if mothers fants who have been receiving drug-contaminated with implants breastfeed. This concern was initially human milk are urged to document these effects in a raised in reports that described esophageal dysfunc- communication to the Food and Drug Administra- tion in 11 children whose mothers had implants.17,18 tion (http://www.fda.gov/medwatch/index.html) This finding has not been confirmed by other reports. and to the Committee on Drugs. This communication Silicone chemistry is extremely complex; the poly- should include the generic and brand names of the mer involved in the covering and the interior of the drug, the maternal dose and mode of administration, breast implant consists of a polymer of alternating the concentration of the drug in milk and maternal silicon and oxygen atoms with methyl groups at- and infant blood in relation to the time of ingestion, tached to the oxygen groups (methyl polydimethyl- the method used for laboratory identification, the siloxane).19 The length of the polymer determines age of the infant, and the adverse effects. Such re- whether it is a solid, gel, or liquid. There are only a ports may substantially increase the pediatric com- few instances of the polymer being assayed in the munity’s fund of knowledge regarding drug transfer milk of women with implants; the concentrations are into human milk and the potential or actual risk to not elevated over control samples.20 There is no ev- the infant. idence at the present time that this polymer is di- rectly toxic to human tissues; however, concern also Committee on Drugs, 2000–2001 exists that toxicity may be mediated through an im- Robert M. Ward, MD, Chairperson munologic mechanism. This has yet to be confirmed Brian A. Bates, MD William E. Benitz, MD in humans. Except for the study cited above, there David J. Burchfield, MD have been no other reports of clinical problems in John C. Ring, MD 21 infants of mothers with silicone breast implants. It Richard P. Walls, MD, PhD is unlikely that elemental silicon causes difficulty, Philip D. Walson, MD because silicon is present in higher concentrations in Liaisons cow milk and formula than in milk of humans with 22 John Alexander, MD implants. The anticolic compound simethicone is a Food and Drug Administration Alternate silicone and has a structure very similar to the Donald R. Bennett, MD, PhD methyl polydimethylsiloxane in breast implants. American Medical Association/United States Simethicone has been used for decades in this coun- Pharmacopeia try and Europe without any evidence of toxicity to Therese Cvetkovich, MD infants. The Committee on Drugs does not feel that Food and Drug Administration the evidence currently justifies classifying silicone Owen R. Hagino, MD implants as a contraindication to breastfeeding. American Academy of Child and Adolescent Psychiatry DRUG THERAPY OF THE LACTATING WOMAN Stuart M. MacLeod, MD, PhD Canadian Paediatric Society The following should be considered before pre- Siddika Mithani, MD scribing drugs to lactating women: Bureau of Pharmaceutical Assessment Health 1. Is drug therapy really necessary? If drugs are Protection Branch, Canada required, consultation between the pediatrician Joseph Mulinare, MD, MSPH Centers for Disease Control and Prevention and the mother’s physician can be most useful in Laura E. Riley, MD determining what options to choose. American College of Obstetricians and 2. The safest drug should be chosen, for example, Gynecologists acetaminophen rather than aspirin for analgesia.

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