Lecture 7

Breastfeeding and drugs, and acceptable medical reasons for artificial feeding

Dr. Varsha Atul Shah

Why drugs taken by mother is a concern?

• Drugs may pass through breast milk to infant maybe harmful

• Most drug levels in the breast milk < 1 - 2% of ingested maternal dosage

• The amount of drug an infant receives from the mother often is negligible.

• The majority of drugs that are given to breastfeeding women do not cause problems in infants

• Most safety data are on single case reports or small case series

Basic questions to determine drug safety

• Does the drug transfer into breast milk?

• What is the effect on the infant?

• Is the medicine routinely given to infants of this age?

• Is the medication absorbed when given orally?– If no, it is safe, Heparin

• Can the infant excrete the medication?

Factors affecting drug transfer:

• Pharmocokinetics factors

• Maternal factors

• Infant factors

Pharmocokinetics factors

– Volume of distribution

– Percentage of maternal protein binding

– Molecular weight

– Water or lipid soluble

– pH

– T max

– T1/2

– Milk-to-plasma ratio

– Active transport

– Relative infant dose

Maternal factors

• Mammary epithelium may have drug-metabolizing capacity

• Milk volume & fat content

• Stage of breast-feeding

Infant factors • Ability to absorb, detoxify & excrete drugs

• High percentage of total body water

• Immature stratum corneum

• Less well developed gastric system– less acidic environment – longer gastrointestinal (GI) transit time – low amounts of some metabolic enzymes in the GI tract, liver, kidney, and

brain to metabolize drugs.

• Others: genetics, environment, diseases, types of treatment, growth & development

Refer pharmacist• Evaluate the safety outcome of medication therapy in breast-feeding (BF)

mothers

• Drug info– name, strength, & dosage form – Reason drug being prescribed. Essential?

• Maternal info– Does she feel need to take the drug? – Physician’s views with regards to BF outcome & taking the drug– Drug dosage schedule & frequency of BF

• Baby’s info– Age, gestation, weight, current medication(s)

Stepwise approach

• Withhold the drug • Try nondrug therapies • Delay therapy• Choose drugs that pass poorly into milk• Choose more breast-feeding–compatible dosage forms• Choose an alternative route of administration• Avoid nursing at times of peak drug concentrations in milk• Administer the drug before the infant’s longest sleep period • Temporarily withhold breast-feeding • Discontinue nursing

Resources for references• LactMed

• Breastfeeding: A Guide for the Medical Profession 7th ed (Lawrence, 2011 p. 750-903)

• Drugs in Pregnancy and Lactation 7th ed. Briggs, Freeman and Yaffe. (Briggs, 2005)

• Medications and Mothers' Milk. 14th Ed. 2010, Thomas Hale. (Hale, 2010)

Infant conditions

• Breast milk or any other milk are contraindicated

• Classic galactosemia

• Maple syrup urine disease

• Phenylketonuria

Infant conditions

• Infants for whom breast milk remains the best feeding option but who may need other food in addition to breast milk for a limited period

– BW < 1500 g

– < 32 weeks gestational age

– at risk of hypoglycaemia if blood sugar fails to respond to optimal breastfeeding or breast-milk feeding

Maternal conditions that may justify permanent avoidance of breastfeeding

• HIV infection:

– if replacement feeding is acceptable, feasible, affordable, sustainable and safe

Maternal conditions that may justify temporary avoidance of breastfeeding

• Severe illness: – that prevents a mother from caring for her infant, e.g.

sepsis

• HSV-1:– direct contact between lesions on the mother’s

breasts and the infant’s mouth should be avoided until all active lesions have resolved

Maternal conditions that may justify temporary avoidance of breastfeeding

• Maternal medication:

– Sedating psychotherapeutics, anti-epileptics, opioids & their combinations

– Radioactive iodine-131

– Cytotoxic chemotherapy

– Excessive use of topical iodine or iodophors esp on open wounds or mucous membranes

Maternal conditions during which breastfeeding can still continue, although health problems may be of concern

• Breast abscess: – BF should continue on the unaffected breast; feeding from the

affected breast can resume once treatment has started

• Hepatitis B: – Infants should be given hepatitis B vaccine, within the first 48

hours or ASAP thereafter

• Hepatitis C

Maternal conditions during which breastfeeding can still continue, although health problems may be of concern

• Mastitis: – If BF is very painful, milk must be removed by

expression to prevent progression of the condition

• Tuberculosis: – Mother & baby should be managed according to

national TB guidelines

Maternal conditions during which breastfeeding can still continue, although health problems may be of concern

• Substance use:

–maternal use of nicotine, alcohol, ecstasy, amphetamines, cocaine & related stimulants has been demonstrated to have harmful effects on breastfed babies

–Alcohol, opioids, benzodiazepines & cannabis can cause sedation

–Mothers should be encouraged not to use these substances & given opportunities and support to abstain

SUBSTANCE USE

Recreational drug use

• BF should be interrupted for 24 to 48 hours (24 hours for cocaine) after the last dose

• The T1/2 for each metabolite may prolong the unsafe duration of the drug

• Even with interrupted BF, infants still may test positive for drugs for days or weeks. PCP & cocaine may be the most dangerous.

• Social considerations (ability for child care)

Mothers on recreational drugs

•Assessment for their dependability

•High-risk mothers discontinue BF

•Low-risk mothers educate about drug transfer & the hazards

• Inform mothers that baby will test positive during drug screenings for a long period after her last drug taking

Methadone

• Methadone concentration remains low in the breast milk - potential infant exposure is unlikely to have any negative effect on the developing child

• Even at a maximal allowable pediatric dose of 270 μg/day, no serious health or developmental concerns have been observed

• Mothers using methadone are recommended to continue BF

Guidelines for Breastfeeding and the Drug-Dependent Woman

• Must abstain from use of illicit drugs for 90 days before delivery

• Are enrolled, active, and planning to continue in a substance abuse treatment program

• Have a negative drug screen at delivery

• Have received consistent prenatal care

• Have no other contraindications to breastfeeding

Alcohol

• Beer – galactagogue (increase prolactin)

• Conversely, alcohol suppresses oxytocin levels reduces milk ejection

• Mothers’ alcohol use showed a 23% reduction in the amount of milk ingested by babies

• BF should be discontinued if mother consumes > 1 drink/hour

Alcohol

• Alcohol gives a noticeable odour to breast milk, which may stimulate sucking initially but decreases the total milk intake during a feeding

• Spends less time sleeping

• Can cause infant "drunkenness" (deep sleep, deep respiration, inability to suck, and no reaction to pain)

Alcohol

• Chronic intake of alcohol 50 cans of beer/week causes a pseudo-Cushing syndrome

• An occasional alcoholic drink not harmful to the infant

• Binge drinking or chronic drinking should be avoided

• Mothers consuming alcohol can resume BF after moderate alcohol use as soon as the effects of the alcohol have passed

Cigarette Smoking (Nicotine)

• Women who smoke are less likely to initiate breastfeeding

• Decreases milk production

• Significant increase of infantile colic

• At least 19% lower milk fat in smoking mothers

• Women who smoke can & should breastfeed

• Nicotine cessation therapy should be recommended & nicotine replacement therapy as adjunct therapy

• Nicotine patches with appropriately managed doses were demonstrated to decrease the absolute infant intake of nicotine & its metabolite

Antidepressants• Psychotherapy should be the first line of treatment

• Medication should be started if psychotherapy is not available, is not working

• Needed due to the severity of the depression

• All antidepressants are excreted in breast milk

• Serum levels of antidepressants in infants of breastfeeding mothers have been evaluated

Selective serotonin reuptake inhibitors (SSRIs)

• Sertraline has been recommended due to its lack of side effects in the infant and unmeasurable drug levels in the infant

• Fluoxetine and its active metabolite (norfluoxetine) have long half lives

• Tricyclic antidepressants, nortriptyline has been the most extensively studied. Levels are not measurable in infants

• It is recommended to start at 1/2 of the recommended dosage and increased on a weekly basis with close monitoring

OTC products

– Avoid taking if

• little BF information is available

• safer products are available

• combination products with multiple ingredients

• extra-strength forms

• long-acting OTC products especially if an adverse reaction is possible

Safe painkiller

•Acetaminophen/Paracetamol

• Ibuprofen

If failed,

•Codeine

References1. Technical updates of the guidelines on Integrated Management of Childhood Illness (IMCI). Evidence and

recommendations for further adaptations. Geneva, World Health Organization, 2005.2. Evidence on the long-term effects of breastfeeding: systematic reviews and meta-analyses. Geneva, World

Health Organization, 2007.3. León-Cava N et al. Quantifying the benefits of breastfeeding: a summary of the evidence. Washington, DC,

Pan American Health Organization, 2002 (http://www.paho.org/English/AD/FCH/BOB-Main.htm, accessed 26 June 2008).

4. Resolution WHA39.28. Infant and Young Child Feeding. In: Thirty-ninth World Health Assembly, Geneva, 5–16 May 1986. Volume 1. Resolutions and records. Final. Geneva, World Health Organization, 1986 (WHA39/1986/ REC/1), Annex 6:122–135.

5. Hypoglycaemia of the newborn: review of the literature. Geneva, World Health Organization, 1997 (WHO/CHD/ 97.1;http://whqlibdoc.who.int/hq/1997/WHO_CHD_97.1.pdf, accessed 24 June 2008)

6. HIV and infant feeding: update based on the technical consultation held on behalf of the Inter-agency Task Team (IATT) on Prevention of HIV Infection in Pregnant Women, Mothers and their Infants, Geneva, 25–27 October 2006. Geneva, World Health Organization, 2007 http://whqlibdoc.who.int/publications/2007/9789241595964_eng.pdf,accessed 23 June 2008).

7. Breastfeeding and maternal medication: recommendations for drugs in the Eleventh WHO Model List of Essential Drugs. Geneva, World Health Organization, 2003.

8. Medications and breast- feeding: Current concepts. Frank J. Nice and Amy C. Luo. J Am Pharm Assoc. 2012;52:86–94.

9. Acceptable medical reasons for use of breast-milk substitutes. WHO/NMH/NHD/09.01 WHO/FCH/CAH/09.01

References

10. Mastitis: causes and management. Geneva, World Health Organization, 2000 (WHO/FCH/CAH/00.13; http://whqlibdoc.who.int/hq/2000/WHO_FCH_CAH_00.13.pdf, accessed 24 June 2008).

11. Hepatitis B and breastfeeding. Geneva, World Health Organization, 1996 (Update No. 22).

12. Breastfeeding and Maternal tuberculosis. Geneva, World Health Organization, 1998 (Update No. 23).

13. Background papers to the national clinical guidelines for the management of drug use during pregnancy, birth and the early development years of the newborn. Commissioned by the Ministerial Council on Drug Strategy under the Cost Shared Funding Model. NSW Department of Health, North Sydney, Australia, 2006 (http://www.health.nsw.gov.au/pubs/2006/bkg_pregnancy.html, accessed 24 June 2008).

14. Medications and breast- feeding: Current concepts. Frank J. Nice and Amy C. Luo. J Am Pharm Assoc. 2012;52:86–94.

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