Medications and Breastfeeding:
Pharmacists as Part of the Mother’s
Breastfeeding Team
Frank J. Nice, RPh, DPA, CPHP
301-840-0270
fjncat@hotmail.com
www.nicebreastfeeding.com
I have the following relevant financial relationship to disclose:
Modest value relationship as author for Hale Publishing
Medications and Breastfeeding:
Current Concepts
• Only essential drugs should be taken by the nursing
mother. She should be knowledgeable of and be
encouraged to report any adverse effects
• For newer drugs, sufficient information is often
unavailable. If information is available, it requires
careful interpretation and evaluation
• Recognizing the benefits of continuing to nurse, in
most cases, drugs that have safe therapeutic levels can
be given
• The long-term effects of most drugs - on mothers as
well as on their nurslings - often are not known
• Use all available resources
•
•
Drug Factors
General Guidelines
1. Most drugs appear in breast milk to some degree
2. Levels of most drugs in breast milk do not usually
exceed 1% to 2% of ingested maternal dosage
3. If the milk/plasma ratio of drug and active
metabolites is less than 1:1, it is usually safe to
breastfeed
4. RID: If infant dose is less than 10% of maternal
dose (weight adjusted), it is usually safe to
breastfeed
Drug Factors
Pharmacokinetics
1.
Volume of Distribution
(1-20 L/Kg)
2.
pH (breast milk more acidic)
3.
Lipids
4.
Protein-Bound Drugs
(>85%)
5.
Molecular Size (Daltons)
(>200-400)
6.
Active Transport
Maternal Factors
Pharmacodynamics
1. Mammary epithelium may have drug metabolizing capacity
2. Milk volume is usually greatest in the early
morning
3. Fat content of milk is usually highest in the
late morning
4. Stage of breastfeeding is factor
Stages of Breastfeeding
•
•
•
•
•
Newborns feed every 1-2 hours (Why?)
Colostrum (0-3 days)
Transitional Milk (4-7 days)
Mature Milk (7-10 days)
Alveolar Spaces (0-7 days)
Infant Factors (See Handout)
Pharmacodynamics
1. Infant’s ability to absorb and metabolize
drugs
2. Infant’s ability to detoxify and excrete drugs
through metabolic enzymes
3. Miscellaneous factors
9
Is Drug X OK to take while
breastfeeding?
No, it is not safe to
breastfeed. You
should wean your
baby.
Oops; we need
to ask some
questions here!
Lack of encouragement and
informed counseling from
healthcare professionals
(including pharmacists) on
medication use during
breastfeeding is one of the
main obstacles to successful
breastfeeding
Questions To Ask In Drug / Breastfeeding
Situations (See Handout)
1.
What is the name, strength, and dosage of the drug?
2.
Do you still have the prescription? Or, have you
already filled it and are taking the drug?
3.
Why is the drug being prescribed?
4.
Do you feel you need to take the drug?
5.
What does your doctor say regarding breastfeeding
outcome and taking the drug?
6.
What is the drug?
Questions To Ask In Drug / Breastfeeding
Situations (See Handout)
7. How old is your baby?
8. Was your baby full-term or premature?
9. What is your baby's weight?
10. Is your baby currently receiving any medication?
11. Do you know how to hand-express breast milk or
do you have access to a breast pump?
12. Is this your first breastfed baby?
Stepwise Approach To Minimizing Infant
Drug Exposure (See Handout)
1. Withhold the drug
2. Try nondrug therapy
3. Delay therapy
4. Choose drugs that pass poorly into breast milk
5. Choose more breastfeeding compatible
dosage forms
Stepwise Approach To Minimizing Infant
Drug Exposure (See Handout)
6. Choose an alternative route of
administration
7. Avoid nursing at times of peak drug
concentrations in milk
8. Administer drug immediately after
breastfeeding and / or before infant's
longest sleep
9. Temporarily withhold breastfeeding
10. Discontinue breastfeeding (wean)
Mrs. Maine and Daughter Acadia
After Birth
16
CASE STUDY
• Mrs. Maine, a breastfeeding woman, presents a
prescription to the pharmacist for an antibiotic to
be filled. She is worried about taking this
medication while breastfeeding and asks for the
pharmacist’s recommendation. She wants to know
if the antibiotic is safe to take while breastfeeding
her baby, Acadia.
17
CASE STUDY (continued)
• After the pharmacist asks the mother several
questions about herself and her baby, the mother
states that she will be back in two hours to pick up
her filled prescription if you determine that the
drug is usually safe to take while breastfeeding.
• What questions should the pharmacist have asked
the mother?
Questions to Ask Mrs. Maine
• Are you breastfeeding (Duh: in case patient did
not tell you she was breastfeeding)?
• Mother’s DOB and Acadia’s DOB
• Mother’s weight and Acadia’s weight
• Any allergies (including drugs) for mother and
Acadia
• Are mother and Acadia taking any other
medications, including OTCs, herbals, and
vitamins?
19
CASE STUDY (continued)
• From the mother, the pharmacist was able to
obtain the following information:
• The mother weighs 110 pounds (50 Kg). The
mother and baby have no drug allergies. Her baby
is seven months old, taking no medications, and
weighs 22 pounds (10 Kg). Breastfeeding is going
very well.
20
CASE STUDY (continued)
• The prescription is for: Xybotic, 1000 mg every
twelve hours for five days
(2000 mg per day)
21
CASE STUDY (continued)
• Will the pharmacist be able to fill the prescription
as written with enough assurance that when Mrs.
Maine takes Xybotic, it should be safe for her to
continue to breastfeed Acadia while taking the
drug?
22
CASE STUDY (continued)
• The pharmacist is unable to find any research or
case study reports regarding Xybotic while
breastfeeding. (Why?)
• What is the next step?
23
Next Step
• The pharmacist runs a computer search on
Xybotic.
• The pharmacist chooses to search Micromedex.
24
CASE STUDY (continued)
• The pharmacist runs a Micromedex search on
Xybotic and comes up with the following
information:
• Xybotic is 90 percent bound to plasma protein, has
a fairly low fat solubility, has a volume of
distribution of 1400 L, has a molecular mass (size)
of 300 Daltons, peaks in plasma in one hour, and
has a half-life of four hours.
25
CASE STUDY (continued)
Protein: +
Fat Solubility: +
Daltons: +/Volume of Distribution: +
Peak: Avoid breastfeeding 0-2 hours after
dose, if possible
• Half-Life: Should not accumulate in baby (Why?)
•
•
•
•
•
Relative Infant Dose (RID)
• If RID is less than 10%, medication is “usually”
compatible with breastfeeding
• Calculation:
Baby’s weight adjusted dose /
Mother’s weight adjusted dose =
RID (expressed as %)
Relative Infant Dose (RID)
• The pharmacist also is able to find a drug reference in
Micromedex that states when five mothers took
Xybotic, an average of 0.01 mg of the drug appeared in
1 mL (10 mg/L) of breast milk {or 150 mL/Kg
(baby)/day}
• Doing the calculations for the RID:
• Baby’s weight adjusted dose: 1 mg/Kg/day (10 mg
drug dose daily from ingested milk / 10 Kg child’s
weight)
• Mother’s weight adjusted dose: 40mg/Kg/day
(2000 mg daily drug dose / 50 Kg mother’s weight)
• Baby/Mother Percentage (RID) (1/40) = 2.5%
28
Photo Courtesy of NIH
29
CASE STUDY (continued)
• What recommendation should the pharmacist
provide to Mrs. Maine as she is counseled?
• What should the pharmacist do if the drug was not
compatible with breastfeeding?
30
Recommendation
• OK to breastfeed while taking Xybotic
• Observe for possible adverse effects in child
(diarrhea or possible allergic reaction)
• Not necessary, but can avoid breastfeeding until
2 hours after taking drug
31
What Else Could The Pharmacist Do?
• Look for breastfeeding compatible alternative in
the same drug category (e.g., Hale and LactMed
suggest alternatives) (see Handouts)
• If no alternative drug, go through the Stepwise
Approach (see Handout)
32
Prescription Drugs
• Nonnarcotic Analgesics: Acetaminophen, ibuprofen, and
NSAIDs with short half-lives are the drugs of choice
• Narcotic Analgesics: Codeine and similar narcotics
(except for patients who are rapid metabolizers) are the
drugs of choice
• General and Epidural Anesthetics: These may decrease
latching and maintenance of feeding
• Anti-Infectives: Most are compatible; monitor for allergic
reactions
• Antihistamine/Decongestants: May decrease milk
production (especially if breastfeeding after six months);
maintain adequate fluid intake when used
Prescription Drugs
• Bronchodilators: Inhalants are the most
compatible form to use
• Corticosteroids: Usually compatible; inhalants
are the most compatible form to use
• Antihypertensives: Each drug category has
compatible drugs
• Diuretics: Usually compatible; maintain adequate
fluid intake when used
• Cardiac Drugs: Each drug category has
compatible drugs
Prescription Drugs
• Anticoagulants: Heparin and warfarin are compatible
• Antidiabetics: Insulin and metformin are the drugs of
choice
• Thyroid/Anti-Thyroid Drugs: Thyroid is compatible;
check individual anti-thyroid drugs for compatibility
• Hormone Contraceptives: May decrease milk supply
and affect milk quality and milk components; wait 6
months before using
• Gastrointestinal Drugs: Antacids, H2 antagonists, and
proton pump inhibitors are compatible: e.g., Pepcid,
Zantac, Tagamet, Prilosec OTC
Prescription Drugs
• Psychotherapeutic Drugs: Recommend that if antidepressant
taken during pregnancy, continue while breastfeeding. Also,
may be started during breastfeeding. Benefit-risk analysis
favorable and condoned by AAP and APA
(See next slide for antidepressant drugs of choice)
• Benzodiazepines: Single, low dose, short half-life drugs
compatible; oxazepam is drug of choice
• Antiepileptics: Most are compatible based on benefit-risk
analysis. Combination drug treatment may cause poor sucking
feeding.
• Radiopharmaceuticals: Can test milk samples and/or follow
established guidelines for individual agents
• Miscellaneous: All vaccines, except smallpox (due to baby
breastfeeding, physical nearness to vaccine site) are compatible
Antidepressant Drugs of Choice
•
•
•
•
•
•
•
1. Sertraline (Zoloft)
2. Escitalopram (Lexapro)
3. Paroxetine (Paxil)
4. Venlafaxine (Effexor)
5. Fluvoxamine (Luvox)
6. Citalopram (Celexa)
7. Fluoxetine (Prozac)
Adverse Effects
(Overall Rate: 1%)
• Psychotherapeutics (Antidepressants, Sedatives,
Antipsychotics): 31%
• Antimicrobials: 17%
• Anticonvulsants: 16%
• Analgesics (NSAIDs, Opioids): 12%
• Hormonal Drugs: 5%
• Iodides: 5%
• Cardiovascular Drugs: 4%
• GIT Drugs: 2%
• Antihistamines: 2%
• Chemotherapeutics: 2%
39
Adverse Effects
• Psychotherapeutics (Antidepressants, Sedatives,
Antipsychotics): Drowsiness
• Antimicrobials: Diarrhea
• Anticonvulsants: Drowsiness, sedation, poor feeding
• Analgesics (NSAIDs, Opioids): Drowsiness, sedation
• Hormonal Drugs: Decreased milk supply, volume,
quantity
• Iodides: Thyroid suppression
• Cardiovascular Drugs: Weakness, hypotension,
bradycardia
• GIT Drugs: GIT upset
• Antihistamines: Irritability, drowsiness
• Chemotherapeutics: Toxic effects of treatment
40
Adverse Effects
(References)
Anderson PO, Pochop SL, Manoguerra AS: Adverse
drug reactions in breastfed infants: less than
imagined. Clin Ped: 42 (4), 325-40: 2003
Ito S, Blajchman A, Stephenson M, et al: Prospective
follow-up of adverse reactions in breast-fed
infants exposed to maternal medication. Am J
Obstet Gynecol: 168 (5), 1393-9: 1993
41
Codeine Rapid Metabolizers
• 13-day breastfed baby dies from morphine
overdose in breast milk in mother taking codeine
• How did that ever happen?
42
Codeine Rapid Metabolizers
• A 13-day old breastfed infant died from morphine
overdose when the mother took codeine to treat
episiotomy pain.
• After the death, a genetic test showed the mother to be
a rapid metabolizers of codeine.
• The chance of being a rapid metabolizers ranges from
less than 1 per 100 to 28 per 100 people.
• Only a genetic test can tell if a person is affected, but
there is only limited information about using this test
for codeine metabolism to morphine.
• In most cases, codeine is, and continues to be,
appropriate treatment for pain while breastfeeding.
• It should be used at the lowest dose for the shortest
period of time.
43
Codeine Rapid Metabolizers (continued)
• The mother in this case noted excess drowsiness in herself,
so the physician lowered the dose, but the drowsiness
continued.
• The mother continued to take the codeine for an extended
time.
• During this time, her baby also began to experience similar
signs because of the high level of morphine in the breast milk.
• After 13 days, the baby experienced depression and died.
• It seems apparent that the mother was not counseled
properly on the potential adverse effects of codeine (rapid
metabolizers or not) on her breastfed child.
• A mother should never have a breastfed baby in respiratory
depression before realizing the medication she is taking has
led to the outcome.
CONSIDERATIONS:
OTC Medications
• Analgesics
• Cough, Cold, and Allergy
Preparations
• Cough and Cold Lozenges and
Sprays
• Nasal Preparations
• Asthma Preparations
• Antacids and Digestive Aids
• Laxatives / Stool Softeners
• Anti-Diarrheal Preparations
• Nausea and Vomiting / Motion
Sickness Preparations
• Hemorrhoidal Preparations
• Sleep Preparations
• Stimulants
• Appetite Suppressants
• Insulin Preparations
• Artificial Sweeteners
• Miscellaneous OTCs
45
OTC
BREASTFEEDING COUNSELING GUIDELINES
• Avoid taking OTC medications for which safer
products are available.
• Avoid taking OTC medications for which little
breastfeeding information is available.
• Avoid taking combination OTCs, which are those
with multiple ingredients (it is better for the mother
to take an OTC that has the one or two specific
ingredients that will treat her specific condition;
there is no need for the mothers or nurslings to be
exposed to unnecessary ingredients).
46
OTC
BREASTFEEDING COUNSELING GUIDELINES
• Avoid taking extra strength forms of OTC medications
(there is no need for the nursling to be exposed to extra
amounts of a drug when it is not needed).
• Avoid taking long-acting OTC medications (there is no
need for the nursling to be exposed to a drug for a longer
period of time, especially if an adverse reaction is
possible in the nursling).
• The mother should know about possible side effects that
might occur in her nursling, as well as herself.
• If possible, as with prescription drugs, the mother should
use a nondrug approach for treating her symptoms.
47
CONSIDERATIONS (See Nice Articles and Books):
Herbals (Major Galactogogues)
• Chaste Tree
• Fennel
• Fenugreek
• Garlic
• Goat's Rue
• Milk Thistle / Blessed Thistle
48
CONSIDERATIONS (See Nice Articles and Books):
Herbals (Minor Galactogogues)
•
•
•
•
•
•
•
Anise
Borage
Alfalfa
Caraway
Coriander
Dandelion
Dill
•
•
•
•
•
•
•
Marshmallow
Nettle
Hops
Oat Straw
Red Clover
Red Raspberry
Vervain
49
CONSIDERATIONS (See Nice Articles and Books):
Herbals
• Analgesics
Bugleweed, Comfrey
• Headache (Migraine) Agents
Feverfew
• Anti-Anxiety Agents
Indian Snakeroot, Kava Kava, Passionflower,
St. John’s Wort, Valerian
• Stimulants
Ginseng Root, Siberian Ginseng, Ginkgo Biloba,
Angelica Root / Dong Quai
• Sleep Preparations
Melatonin (Not Herbal)
50
CONSIDERATIONS (See Nice Articles and Books):
Herbals
• Cough, Cold, and Allergy Products
Coltsfoot, Echinacea, Elder Flower
• Gastrointestinal Agents
Aloe, Buckthorn, Cascara Sagrada, Chamomile,
Flaxseed, Licorice, Psyllium Seed, Rhubarb, Senna
• Nausea and Vomiting Preparations
Ginger
• Lipid Lowering Agents
Soy Lecithin
• Urinary Tract Preparations
Goldenrod, Petasites, Uva Ursi
CONSIDERATIONS:
Recreational Drugs
•
•
•
•
•
•
•
•
Amphetamine / Methylphenidate
Marijuana
Cocaine
Phencyclidine
Narcotics
Caffeine
Alcohol
Nicotine
52
Recommendations for Recreational
Drug Use (See Handout)
• Drugs’ Effects
• Social Considerations
• Physician Recommendations
• Alcohol Use Facts
• PLUS: Do NOT want social services taking
baby away from mother
53
RECREATIONAL DRUGS
Amphetamine / Methylphenidate
• Levels in breast milk difficult to obtain due to large
volume of distribution
• Possibility of irritability or poor sleep pattern
• Abuse: hypertension, palpitations, tachycardia, over
stimulation, motor incoordination, tremor,
restlessness
54
RECREATIONAL DRUGS
Cocaine
• Apnea and seizures in breastfed infant who ingested
cocaine which was applied topically as anesthetic
• Abuse: tachycardia, tachypnea, hypertension,
irritability, tremulousness
• One of most dangerous of all drugs of abuse
55
RECREATIONAL DRUGS
Phencyclidine
• Potent hallucinogen
• Long half-life of metabolites
• One of most dangerous of all drugs of abuse
56
RECREATIONAL DRUGS
Narcotics
• Codeine, Morphine, Meperidine, Heroin
• Large doses can cause dependence and withdrawal
symptoms in nurslings
• Use proper withdrawal techniques
Wean Breastfed Baby Off Narcotics
• There are several ways to “wean” a baby off narcotics to
avoid withdrawal symptoms:
1. Use of Diluted Tincture of Opium (DTO) in the infant,
which would be the least preferred
2. Gradually wean the baby and maintain the narcotic dose
level, which is better, but not the most preferred
3. Gradually reduce the narcotic dose while maintaining
breastfeeding, which the best option
• During these processes, the mother may use Suboxone or
methadone.
• Methadone can be used safely at doses above 100 mg
daily for over 30 days, if necessary, while the mother is
breastfeeding
58
RECREATIONAL DRUGS
Caffeine
• Even though clearance of caffeine in infants is
markedly reduced, amounts of caffeine ingested by
breastfeeding children is small, if reasonable
amounts of coffee, tea, or colas are used by mother
(1 to 2 cups per day)
• Mothers of newborns, and in particular of
premature newborns, should avoid caffeine
• Note: Caution if taking theophylline also (Why?)
59
RECREATIONAL DRUGS
Alcohol (See Handout)
• 1 to 2 cocktails, glasses of wine, or bottles of beer: Usually
insignificant levels
• Odor of alcohol in milk may cause infants to consume
significantly less milk
• Excessive, chronic drinking: Mild sedation to deep sleep,
hypoprothrombinemic bleeding
• Caution: Intoxicated mothers should not breastfeed;
chronic alcoholics should not breastfeed
• Because of rational use of alcohol is possible during
breastfeeding, the use of Alcohol Breast Milk Tests is a
complete waste of money, time, and effort.
60
RECREATIONAL DRUGS
Marijuana
• Tetrahydrocannabinol (THC) concentrated in breast
milk and is absorbed by the nursing baby
• Long-term effects may occur (both mother and
baby)
61
Schedule I
Controlled Substances
• Substances have a high potential for abuse, have no
currently accepted medical use in treatment in the
U.S., and have a lack of accepted safety for use
under medical supervision
• Marijuana is Schedule I
62
Marijuana Consequences
• CONSEQUENCES
• Mother also potentially abusing other drug substances: marijuana
users usually do
• Exposure to marijuana smoke is potentially hazardous and toxic as
is cigarette smoke
• Current evidence indicates that marijuana during lactation may
adversely affect neurodevelopment, especially during critical brain
growth during adolescent maturation
• Marijuana impacts neuropsychiatric, behavioral, and executive
functioning, which may affect future adult productivity and
lifetime outcomes (delinquency, depression, and substance
abuse)
• Law passed in States, which makes recreational use of marijuana legal
render toxicology interpretation complex (is mother using
recreational and/or medical marijuana “legally” or illicitly and thus
exposing breastfed baby to “legal” or illicit marijuana?)
Hopalong Cassidy
64
RECREATIONAL DRUGS
• From both a philosophical and scientific viewpoint,
recreational drugs of abuse should be
contraindicated during breastfeeding as they are
hazardous, not only to the nursling, but to the
mother as well.
fjncat@hotmail.com
66
Thank YOU for your attention
and participation