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 ...
Basic questions to determine drug
safety
• Does the drug transfer into breast milk?
• What is the effect on the infant?
• ...
Factors affecting drug transfer:
• Pharmocokinetics factors
• Maternal factors
• Infant factors
Pharmocokinetics factors
– Volume of distribution
– Percentage of maternal
protein binding
– Molecular weight
– Water or l...
Maternal factors
• Mammary epithelium may have drug-
metabolizing capacity
• Milk volume & fat content
• Stage of breast-f...
Infant factors
• Ability to absorb, detoxify & excrete drugs
• High percentage of total body water
• Immature stratum corn...
Refer pharmacist
• Evaluate the safety outcome of medication therapy in breast-feeding (BF)
mothers
• Drug info
– name, st...
Stepwise approach
• Withhold the drug
• Try nondrug therapies
• Delay therapy
• Choose drugs that pass poorly into milk
• ...
Resources for references
• LactMed
• Breastfeeding: A Guide for the Medical Profession 7th ed (Lawrence, 2011 p.
750-903)
...
Infant conditions
• Breast milk or any other milk are contraindicated
• Classic galactosemia
• Maple syrup urine disease
•...
Infant conditions
• Infants for whom breast milk remains the best feeding
option but who may need other food in addition t...
Maternal conditions that may justify permanent
avoidance of breastfeeding
• HIV infection:
– if replacement feeding is acc...
Maternal conditions that may justify temporary
avoidance of breastfeeding
• Severe illness:
– that prevents a mother from ...
Maternal conditions that may justify temporary
avoidance of breastfeeding
• Maternal medication:
– Sedating psychotherapeu...
Maternal conditions during which breastfeeding can still
continue, although health problems may be of concern
• Breast abs...
Maternal conditions during which breastfeeding can still
continue, although health problems may be of concern
• Mastitis:
...
Maternal conditions during which breastfeeding can still
continue, although health problems may be of concern
• Substance ...
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 ...
Mothers on recreational drugs
•Assessment for their dependability
•High-risk mothers discontinue BF
•Low-risk mothers ed...
Methadone
• Methadone concentration remains low in
the breast milk - potential infant
exposure is unlikely to have any ne...
Guidelines for Breastfeeding and the Drug-
Dependent Woman
• Must abstain from use of illicit drugs for 90 days before del...
Alcohol
• Beer – galactagogue (increase prolactin)
• Conversely, alcohol suppresses oxytocin levels reduces milk
ejection...
Alcohol
• Alcohol gives a noticeable odour to breast milk,
which may stimulate sucking initially but decreases
the total m...
Alcohol
• Chronic intake of alcohol 50 cans of beer/week causes a
pseudo-Cushing syndrome
• An occasional alcoholic drink ...
Cigarette Smoking (Nicotine)
• Women who smoke are less likely to initiate breastfeeding
• Decreases milk production
• Sig...
Antidepressants
• Psychotherapy should be the first line of treatment
• Medication should be started if psychotherapy is n...
Selective serotonin reuptake
inhibitors (SSRIs)
• Sertraline has been recommended due to its lack of side effects in the
i...
OTC products
– Avoid taking if
• little BF information is available
• safer products are available
• combination products ...
Safe painkiller
•Acetaminophen/Paracetamol
•Ibuprofen
If failed,
•Codeine
References
1. Technical updates of the guidelines on Integrated Management of Childhood Illness (IMCI). Evidence and
recom...
References
10. Mastitis: causes and management. Geneva, World Health Organization, 2000 (WHO/FCH/CAH/00.13;
http://whqlibd...
THANK YOU
MCQ AND SCENARIO STATION
6 breastfeeding and drugs and acceptable medical reasons for artificial feeding (edited)
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Breast feeding and medical reasons for formula feeding

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  • [“If no, it is safe, Heparin” – sorry what does this phrase mean?]
  • Drugs with high Vd may enter different compartments of the body, therefore resulting in a lower concentration in the blood. These drugs may take a longer time to clear from the body than drugs with lower Vd. However, drugs may have different elimination half-lives in the plasma and peripheral compartments; thus, drugs with a high Vd may produce lower milk levels.
    PB shows the extent to which a drug is bound to the plasma albumin and other proteins. Therefore, drugs that have high PB would generally reduce the infant’s exposure to the medication.
    Beta-adrenergic blocking drug atenolol has low PB of 6% to 16% and therefore would be more extensively excreted into breast milk.
    Drugs with higher MWs less likely to pass into breast milk. Heparin, interferons, and insulin, for example, are compounds with large MWs and are unlikely to contribute to toxic drug concentrations in breast milk.
    Drug molecules that are water soluble are less likely to concentrate in the breast milk.
    By avoiding feeding the infant at the time the drug reaches its maximum concentration in the plasma (Cmax), the mother can decrease the likelihood of exposing her infant to the drug.
    After five half- lives, approximately 97% of drug is eliminated from breast
    If M/P is less than 1, it is usually safe to breast- feed.
    Relative infant dose. The relative infant dose (RID) is calculated by dividing the theoretical infant weight–adjusted dose supplied via breast milk by the maternal weight–adjusted dose. When RID is less than 10% of maternal dose, the medication is considered generally safe for breast-feeding.
  • Milk volume is usually greatest in the early morning, while the fat content of milk is usually highest in the late morning. Because a larger volume of milk in the breast during the early morning is likely, taking drugs at that time would result in a higher drug concentration in the breast milk.
    Mothers are advised to breast-feed first, then take their medication, thereby decreasing the likelihood of any overexposure to the infant. Similarly, it would be optimal for mothers to take drugs that are less lipid-soluble in the late morning because
    Different stages of breast-feeding can affect the amount transfer of lipid-soluble drugs into breast milk.
    Colostrum
    0 to 3 days; thicker, higher in protein & antibodies, and acts as a laxative.
    Transitional milk
    4 to 7 days , high levels of fat & lactose. Helps in regain weight loss
    Mature milk
    7 to 10 days
    Consisting largely of water
    Foremilk contains more water, vitamins, and protein.
    Hindmilk contains higher levels of fat and aids in the weight gain of infants.
  • High percentage of total body water, and thus higher doses (per kg body weight) of water-soluble drugs are required because a higher percentage of their body weight is water.
    Immature stratum corneum that can increase exposure to applied topical medications.
    less acidic (more alkaline) environment that can alter the rate and amount of drug absorption and metabolization
    their gastrointestinal (GI) transit time also is prolonged because of slower motility
    The low amounts of some metabolic enzymes in the GI tract, liver, kidney, and brain also play a role in an infant’s ability to metabolize drugs.
    Sometimes, their clearance of drugs (e.g., theophyline, phenytoin) is higher than in adults.
  • In most cases, it’s best for the mother to breast-feed just before taking a dose of a drug and/or at least 2 hours after taking a dose. Short-acting drugs taken on an every-3-to-6-hour schedule usually reach peak plasma and milk levels in approximately 1 to 2 hours.
  • LactMed: A peer reviewed and fully referenced database of drugs to which breastfeeding mothers may be exposed.
  • Classic galactosemia: galactose-free formula
    Maple syrup urine disease:special formula free of leucine,isoleucine and valine
    Phenylketonuria: phenylalanine-free formula
    (some breastfeeding is possible, under careful monitoring).
  • Sedating psychotherapeutic drugs, anti-epileptic drugs & opioids & their combinations
    may cause side effects e.g. drowsiness, respiratory depression, are better avoided if a safer alternative is available
    Radioactive iodine-131
    better avoided given that safer alternatives are available - a mother can resume BF about 2/12 after receiving this substance
    Excessive use of topical iodine or iodophors esp on open wounds or mucous membranes:
    can result in thyroid suppression & electrolyte abnormalities in the breastfed infant and should be avoided
  • Low-risk mothers should be given the details of drug transfer into the breast milk & the hazards of the drug to their babies.
  • Research has shown that the methadone concentration remains low in the breast milk such that the potential infant exposure is unlikely to have any negative effect on the developing child.
  • 6 breastfeeding and drugs and acceptable medical reasons for artificial feeding (edited)

    1. 1. Lecture 7 Breastfeeding and drugs, and acceptable medical reasons for artificial feeding Dr. Varsha Atul Shah
    2. 2. 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
    3. 3. 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?
    4. 4. Factors affecting drug transfer: • Pharmocokinetics factors • Maternal factors • Infant factors
    5. 5. 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
    6. 6. Maternal factors • Mammary epithelium may have drug- metabolizing capacity • Milk volume & fat content • Stage of breast-feeding
    7. 7. 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
    8. 8. 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)
    9. 9. 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
    10. 10. 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)
    11. 11. Infant conditions • Breast milk or any other milk are contraindicated • Classic galactosemia • Maple syrup urine disease • Phenylketonuria
    12. 12. 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
    13. 13. Maternal conditions that may justify permanent avoidance of breastfeeding • HIV infection: – if replacement feeding is acceptable, feasible, affordable, sustainable and safe
    14. 14. 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
    15. 15. 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
    16. 16. 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
    17. 17. 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
    18. 18. 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
    19. 19. SUBSTANCE USE
    20. 20. 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)
    21. 21. 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
    22. 22. 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
    23. 23. 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
    24. 24. 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
    25. 25. 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)
    26. 26. 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
    27. 27. 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
    28. 28. 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
    29. 29. 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
    30. 30. 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
    31. 31. Safe painkiller •Acetaminophen/Paracetamol •Ibuprofen If failed, •Codeine
    32. 32. References 1. 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
    33. 33. 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.
    34. 34. THANK YOU MCQ AND SCENARIO STATION
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