Fw: The Transfer of Drugs and Other Chemicals Into Human Milk ~ including silicone implants

[Guest guest]

From: " Ilena Rose " <ilena@...>

Sent: Tuesday, September 04, 2001 9:37 PM

Subject: The Transfer of Drugs and Other Chemicals Into Human Milk ~

including silicone implants

SWEETCAROLINELV@... wrote:

GO DOWN AND SEE WHO GAVE THE INFO ON SILICON AND USED THAT TO COME TO

THE CONCLUSIONS --THE PLASTIC SURGEONS-----SOMETHING HAS TO BE DONE

ABOUTTHIS OR ALOT OF YOUNG WOMEN ARE GOING TO HARM THEIR CHILDREN AND

THE DRS WONT EVEN KNOW WHAT TO DO ----OR BELIEVE THEIR INJURYS

--CAROLINE

~~~~~~~~~~~~~~~~~~~~~~~~~

" sey " <fuchsmorrissey@...> wrote:

ILENA/KATHY, Ladies~ if breast implants are safe, with acceptable risks

then the FDA should give their FDA approval for all breast implants with or

without a genetic predisposition/genetic susceptibility. Why have they not

done this? CFM

~~~~~~~~~~~~~~~~~~~~~~~~~

I think this is more corporate " tobacco

science " and " silicone science " ... bound to put true science back a few

decades. Ilena ~~~

http://www.aap.org/policy/0063.html

The Transfer of Drugs and Other Chemicals Into Human Milk

AMERICAN ACADEMY OF PEDIATRICS

Committee on Drugs

ABSTRACT. The American Academy of Pediatrics places emphasis on increasing

breastfeeding in the United States. A common reason for the cessation of

breastfeeding is the use of medication by the nursing mother and advice by

her physician to stop nursing. Such advice may not be warranted. This

statement is intended to supply the pediatrician, obstetrician, and family

physician with data, if known, concerning the excretion of drugs into

human milk. Most drugs likely to be prescribed to the nursing mother

should have no effect on milk supply or on infant well-being. This

information is important not only to protect nursing infants from untoward

effects of maternal medication but also to allow effective pharmacologic

treatment of breastfeeding mothers. Nicotine, psychotropic drugs, and

silicone implants are 3 important topics reviewed in this statement.

INTRODUCTION

A statement on the transfer of drugs and chemicals into human milk was

first published in 1983,1 with revisions in 19892 and 1994.3 Information

continues to become available. The current statement is intended to revise

the lists of agents transferred into human milk and describe their

possible effects on the infant or on lactation, if known (Tables 1-7). If

a pharmacologic or chemical agent does not appear in the tables, it does

not mean that it is not transferred into human milk or that it does not

have an effect on the infant; it only indicates that there were no reports

found in the literature. These tables should assist the physician in

counseling a nursing mother regarding breastfeeding when the mother has a

condition for which a drug is medically indicated.

BREASTFEEDING AND SMOKING

In the previous edition of this statement, the Committee on Drugs placed

nicotine (smoking) in Table 2, " Drugs of Abuse for Which Adverse Effects

on the Infant During Breastfeeding Have Been Reported. " The reasons for

placing nicotine and, thus, smoking in Table 2 were documented decrease in

milk production and weight gain in the infant of the smoking mother and

exposure of the infant to environmental tobacco smoke as demonstrated by

the presence of nicotine and its primary metabolite, cotinine, in human

milk.4-12 There is controversy regarding the effects of nicotine on infant

size at 1 year of age.13,14 There are hundreds of compounds in tobacco

smoke; however, nicotine and its metabolite cotinine are most often used

as markers of tobacco exposure. Nicotine is not necessarily the only

component that might cause an increase in respiratory illnesses (including

otitis media) in the nursing infant attributable to both transmammary

secretion of compounds and environmental exposure. Nicotine is present in

milk in concentrations between 1.5 and 3.0 times the simultaneous maternal

plasma concentration,15 and elimination half-life is similar-60 to 90

minutes in milk and plasma.7 There is no evidence to document whether this

amount of nicotine presents a health risk to the nursing infant.

The Committee on Drugs wishes to support the emphasis of the American

Academy of Pediatrics on increasing breastfeeding in the United States.

Pregnancy and lactation are ideal occasions for physicians to urge

cessation of smoking. It is recognized that there are women who are unable

to stop smoking cigarettes. One study reported that, among women who

continue to smoke throughout breastfeeding, the incidence of acute

respiratory illness is decreased among their infants, compared with

infants of smoking mothers who are bottle fed.16 It may be that

breastfeeding and smoking is less detrimental to the child than bottle

feeding and smoking. The Committee on Drugs awaits more data on this

issue. The Committee on Drugs therefore has not placed nicotine (and thus

smoking) in any of the Tables but hopes that the interest in breastfeeding

by a smoking woman will serve as a point of discussion about smoking

cessation between the pediatrician and the prospective lactating woman or

nursing mother. Alternate (oral, transcutaneous) sources of nicotine to

assist with smoking cessation, however, have not been studied sufficiently

for the Committee on Drugs to make a recommendation for or against them in

breastfeeding women.

PSYCHOTROPIC DRUGS

Anti-anxiety drugs, antidepressants, and neuroleptic drugs have been

placed in Table 4, " Drugs for Which the Effect on Nursing Infants Is

Unknown but May Be of Concern. " These drugs appear in low concentrations

(usually with a milk-to-plasma ratio of 0.5-1.0) in milk after maternal

ingestion. Because of the long half-life of these compounds and some of

their metabolites, nursing infants may have measurable amounts in their

plasma and tissues, such as the brain. This is particularly important in

infants during the first few months of life, with immature hepatic and

renal function. Nursing mothers should be informed that if they take one

of these drugs, the infant will be exposed to it. Because these drugs

affect neurotransmitter function in the developing central nervous system,

it may not be possible to predict long-term neurodevelopmental effects.

SILICONE BREAST IMPLANTS AND BREASTFEEDING

Approximately 800 000 to 1 million women in the United States have

received breast implants containing silicone (elemental silicon with

chemical bonds to oxygen) in the implant envelope or in the envelope and

the interior gel. Concern has been raised about the possible effects to

the nursing infant if mothers with implants breastfeed. This concern was

initially raised in reports that described esophageal dysfunction in 11

children whose mothers had implants.17,18 This finding has not been

confirmed by other reports. Silicone chemistry is extremely complex; the

polymer involved in the covering and the interior of the breast implant

consists of a polymer of alternating silicon and oxygen atoms with methyl

groups attached to the oxygen groups (methyl polydimethylsiloxane).19 The

length of the polymer determines whether it is a solid, gel, or liquid.

There are only a few instances of the polymer being assayed in the milk of

women with implants; the concentrations are not elevated over control

samples.20 There is no evidence at the present time that this polymer is

directly toxic to human tissues; however, concern also exists that

toxicity may be mediated through an immunologic mechanism. This has yet to

be confirmed in humans. Except for the study cited above, there have been

no other reports of clinical problems in infants of mothers with silicone

breast implants.21 It is unlikely that elemental silicon causes

difficulty, because silicon is present in higher concentrations in cow

milk and formula than in milk of humans with implants.22 The anticolic

compound simethicone is a silicone and has a structure very similar to the

methyl polydimethylsiloxane in breast implants. Simethicone has been used

for decades in this country and Europe without any evidence of toxicity to

infants. The Committee on Drugs does not feel that the evidence currently

justifies classifying silicone implants as a contraindication to

breastfeeding.

DRUG THERAPY OF THE LACTATING WOMAN

The following should be considered before prescribing drugs to lactating

women:

1. Is drug therapy really necessary? If drugs are required, consultation

between the pediatrician and the mother's physician can be most useful in

determining 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 a risk to the infant,

consideration should be given to measurement of blood concentrations in

the nursing infant.

4. Drug exposure to the nursing infant may be minimized by having the

mother take the medication just after she has breastfed the infant or just

before the infant is due to have a lengthy sleep period.

Data have been obtained from a search of the medical literature. Because

methodologies used to quantitate drugs in milk continue to improve, this

information will require frequent updating. Drugs cited in Tables 1

through 7 are listed in alphabetical order by generic name; brand names

are available from 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 International Drug Names.25 The reference list is

not inclusive of all articles published on the topic.

Physicians who encounter adverse effects in infants who have been

receiving drug-contaminated human milk are urged to document these effects

in a communication to the Food and Drug Administration

(http://www.fda.gov/medwatch/index.html) and to the Committee on Drugs.

This communication should include the generic and brand names of the drug,

the maternal dose and mode of administration, the concentration of the

drug in milk and maternal and infant blood in relation to the time of

ingestion, the method used for laboratory identification, the age of the

infant, and the adverse effects. Such reports may substantially increase

the pediatric community's fund of knowledge regarding drug transfer into

human milk and the potential or actual risk to the infant.

COMMITTEE ON DRUGS, 2000-2001

M. Ward, MD, Chairperson

A. Bates, MD

E. Benitz, MD

J. Burchfield, MD

C. Ring, MD

P. Walls, MD, PhD

Philip D. Walson, MD

LIAISONS

, MD

ÝÝFood and Drug Administration Alternate

R. , MD, PhD

ÝÝAmerican Medical Association/United States Pharmacopeia

Therese Cvetkovich, MD

ÝÝFood and Drug Administration

Owen R. Hagino, MD

ÝÝAmerican Academy of Child and Adolescent Psychiatry

Stuart M. MacLeod, MD, PhD

ÝÝCanadian Paediatric Society

Siddika Mithani, MD

ÝÝBureau of Pharmaceutical Assessment Health Protection Branch, Canada

ph Mulinare, MD, MSPH

ÝÝCenters for Disease Control and Prevention

E. Riley, MD

ÝÝAmerican College of Obstetricians and Gynecologists

Sumner J. Yaffe, MD

ÝÝNational Institutes of Health

SECTION LIAISONS

J. CotÈ, MD

ÝÝSection on Anesthesiology

Eli O. Meltzer, MD

ÝÝSection on Allergy and Immunology

CONSULTANT

Cheston M. Berlin, Jr, MD

STAFF

J. Koteras, MHA

ACKNOWLEDGMENT