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Safe or unsafe:
Medication use in pregnancy and
breastfeeding
Sebastian Hamilton
Sheila Hobson
Goals
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To increase knowledge base in order to
have a better understanding of the
benefits and/or consequences of
conventional and natural medication use
during pregnancy and lactation
Objectives
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Describe the FDA pregnancy risk category system
Describe Hale’s Lactation category list
Identify factors to consider when selecting drug therapy
in pregnant and lactating woman
Describe consequences of disease states and medication
use to mother & infant
Identify goals of chronic disease states for pregnant
women
Describe concerns with natural medicine and alcohol use
during lactation
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Medication use in lactation is frequently
controversial.
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There is insufficient data to determine
risks
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Clinicians are poorly educated in regard
to breastfeeding and lactation
Sad Scenario
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Mothers are asked to stop breastfeeding
to take meds because few clinicians
comprehend lactational pharmacology
Conflicting advice is given
Mothers become confused, frightened
and finally stop breastfeeding
What can you do
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Check breastfeeding status before giving
any drug and review the research (we use
Hale’s Medications and Mother’s Milk )
Inform the woman about the drug’s
safety and/or side effects while nursing
Provide alternative options if necessary
Help mothers’ continue breastfeeding
Breastfeeding
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Although most drug packets advise against use
while nursing, there are very few drugs
contraindicated in breastfeeding
Some drugs do cause side-effects in the baby
The safety of drugs depends on the age of the
breastfeeding infant
Premature babies have a different capacity to
absorb and excrete drugs
Drugs may transfer to Human Milk if:
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They attain high concentrations in human
plasma
Are low in molecular weight
Are low in protein binding
Pass into the brain easily
Contraindicated in Lactation
Antineoplastic agents
Ergotamine tartrate (Ergomar)
Bromocriptine (Parlodel)
Lithium
Cyclophosphamide (Cytoxan)
Methotrexate (Rheumatrex)
Cyclosporine (Sandimmune)
Radiopharmaceutical
Herbals and alcohol
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Be cautious of herbal drugs. They are not harmless. Many
contain chemical substances that may be harmful to the
infant. Contact a herbalist or lactation consult
knowledgeable about their use in lactation. Use only
minimal amounts.
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Alcohol transfers to breastmilk readily and is an inhibiter
of oxytocin release, reduces milk letdown and the amount
of milk delivered to the infant. Moderate drinkers should
avoid breastfeeding during and at least 2-3 hrs. after
consumption. Heavy drinkers should wait longer.
Dr. Hale’s Lactation Risk Category:
L1 Safest
Drug which as been taken by a large number of breastfeeding
mothers without any observed increase in adverse effects in the
infant.
Controlled studies in breastfeeding women failed to demonstrate
a risk to the infant and the possibility of harm to the breastfeeding
infant is remote: or the product is not orally bioavailable in an
infant.
L2 Safer
Drug which has been studied in a limited number of breastfeeding
women without an increase in adverse effects in the infant. And/or
the evidence of demonstrated risk which is likely to follow use of
this medication is remote.
L3 Moderately safe
There are no controlled studies in breastfeeding
women; however, the risk of untoward effects to the
breastfed infant is possible, or controlled studies show
only minimal, non-threatening adverse effects. Drugs
should only be given if potential benefit justifies the
potential risk to the infant.
L4
There is positive evidence of risk to a breastfed infant or
to breastmilk production, but the benefits from use in
breastfeeding mothers may be acceptable despite the
risk to the infant. (life threatening situation, serious
disease etc.)
L5
Studies in in breastfeeding mothers have
demonstrated that there is a significant and
documented risk to the infant based on human
experience, or it is a medication that has a high risk
of causing significant damage to an infant. The risk
of using the drug in breastfeeding women clearly
outweighs any possible benefit from breastfeeding.
The drug is contraindicated in women who are
breastfeeding.
Books
Ruth Lawrence. Breastfeeding: A Guide for the Medical
Profession. 5th ed. St. Louis: Mosby, 1999.
Jack Newman, Theresa Pitman. Dr. Jack Newman's Guide to
Breastfeeding. Toronto: Harper Collins Publishing, 2000.
Telephone advice
Yale-New Haven Hospital Lactation Center: 716–275–0088 (9 a.m.
to 5 p.m. EST weekdays)
Internet resources
Dr. Hale's Breastfeeding Pharmacology Page
(http://www.neonatal.ttuhsc.edu/lact)
Case Western Reserve University
(http://www.breastfeedingbasics.org)
FDA Drug Risk Category for
Pregnancy
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Category A – Adequate, well-controlled
studies in pregnant women have not
shown an increased risk of abnormalities.
Category B – Animal studies have reveled
no evidence of harm to the fetus, there
are no adequate and well-controlled
studies in pregnant women.
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Schedule doses immediately after breast feeding or
before a long sleep period
FDA Risk Category
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Category C – Animal studies have shown an
adverse effect and there are no adequate and
well-controlled studies in pregnant women OR
no animal studies have been conducted and
there are no adequate and well-controlled
studies in pregnant women.
Category D – Studies, adequate well-controlled
or observational, in pregnant women have
demonstrated a risk to the fetus. However, the
benefits of therapy may outweigh the potential
risk.
FDA Risk Category
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Category X – Studies, adequate well-controlled
or observational, in animals or pregnant women
have demonstrated positive evidence of fetal
abnormalities. The use of the product is
contraindicated in women who are or may
become pregnant.
Category X drugs – isotretinoin, HMG CoA RI,
temazepam, testosterone, thalidomide, vitamin
A, warfarin
Drugs During Lactation
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Infant Considerations
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Gestational age
Chronological age
Renal function
Hepatic function
Amount of milk
consumed
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Mother Considerations
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Pharmacological effect of
the drug on the mother
Adverse effects of the
medication
Effect on breast milk
composition
Effect on milk production
Lactation
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Medication use during breast feeding
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Contraindicated drug therapy is indicated, pump
breast milk and discard until therapy is complete
(“pump and dump”)
Avoid sustained release preparations or drugs with
long half-lives
Chronic Diseases
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Asthma/Allergic Rhinitis – up to 4%
Depression – up to 20%
Diabetes mellitus – 8% of US population
Hypertension
Thromboembolic disease
Seizure disorders
Risks with Uncontrolled
Asthma
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Mother
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Preterm labor
Gestational HTN
Preeclampsia
Uterine hemorrhage
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Infant
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Intrauterine grown
retardation
Low birth weight
Congenital
malformations
Asthma Management Goals &
Treatment
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Decrease symptoms < 12x/wk, nocturnal
<2x/month
Reduce exposure to
allergens and irritants
Anti-inflammatory –
Cromolyn
Inhaled corticosteroids –
budesonide or
beclomethasone
Rescue medications –
Beta agonists
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Leukotriene inhibitors
Steroids – prednisone,
prednisolone, try to
avoid use in 1st trimester
Theophylline – monitor
levels
Allergic Rhinitis Goals &
Treatment
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Management
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Avoid exacerbating factors
Cromolyn nasal spray
Antihistamines
Decongestant – PSE, limit use
Intranasal steroids – budesonide or
beclomethasone
immunotherapy
Diabetes Goals of Therapy (ACOG
and ADA)
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Achieve glycemic control
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FBS 60 – 95 mg/dl
1 hour PPG<140
HS PPG or 2 hour PPG < 120
Avoid complications, hypo or hyperglycemia
Pre-conception counseling
Close monitoring by provider
Diet management – CHO restriction
Change oral meds to insulin as needed
Diabetes Treatment
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Insulin – drug of choice for T1 & T2
diabetes during pregnancy
Sulfonylureas – glyburide, after 1st
trimester or 11 weeks (not FDA
approved)
Biguanides – metformin (not FDA
approved)
Hypertension
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Chronic HTN – Occurring before 20
weeks of gestation and persisting > than
12 weeks postpartum
JNC & guidelines – Stage I (SBP/DBP
140-159/ 90-99) Stage II (SBP/DBP
160>/100>)
Monitoring – preconception, home BP
Medication Options for HTN
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If pt is on an ACE or ARB – Discontinue!
Drug of choice – Methyldopa
Other options – 2nd line, some beta-blockers,
labetalol (not atenolol), nifedipine, hydralazine,
clonidine
Can consider D/C all meds, but restart if BP 150160/or 100-110 or target organ damage is
present
Depression
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Major depressive disorder
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Increased risk of preeclampsia
Poor nutrition
Suicidal behavior
Medication Treatment
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SSRI’s – citalopram, escitalopram, sertraline, fluoxetine.
Avoid paroxetine!
SNRI’s – duloxetine, venlafaxine
5HT1A agents – buspirone
Thromboembolic Disorders
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6x more common in pregnant women
Maternal physiology changes:
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Increased Vitamin K dependent clotting
factors
Increased platelet function
Venous stasis caused by hormonally
mediated relaxation of vascular smooth
muscle & the compression of pelvic veins
Risk Factors for TD
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Hx of thromboembolism
Hypercoagulable conditions
Operative vaginal delivery of cesarean
section
Obesity
Family Hx of thombosis
Thromboembolic Disorders
Management
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Discontinue warfarin- Category X,
increased risk of fetal hemorrhage.
Greatest risk during 1st trimester
Treatment options – Heparin, LMWH
(anticoagulant of choice). Do not cross
placenta so no fetal bleeding risk
Compression stockings
Epilepsy
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0.5% of all pregnancies are complicated by
epilepsy
Risk of seizure is greatest during labor
Women have an increased incidence of
hyperemesis gravidarum, preeclampsia,
premature labor, and cesarean section
Seizures are more harmful to the fetus than the
teratogenic risk of anticonvulsants
Goals: Prevent seizures AND minimize effects on
the fetus
Fetal AED (Anti Epileptic Drug)
Syndrome
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Associated with:
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Congenital heart malformations
Facial clefts
Spina bifida
Hypospadias
Growth retardation
Psychomotor and mental retardation
Epilepsy Management
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Seizure free x 2 years – slowly taper off
medications
Monotherapy preferred
Folic acid supplementation necessary (4mg/day)
Vitamin K supplementation – prevent
hemorrhagic complications (10mg/day during
the last 1 to 3 weeks of pregnancy)
Calcium and Vitamin D supplementation
Medication Management of
Epilepsy
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Tonic-clonic seizures – consider lorazepam,
diazepam
Eclampsia induced seizures (acute) –
Magnesium, phenytoin
Monitoring
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Serum drug concentration with free levels
Seizure frequency/intensity/ duration
ADR’s
Medication Use in Pregnancy
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Risk versus benefit – Necessity of drug
Generally, mom should be healthy so the fetus
will also be healthy – Diseases are more
dangerous than drug therapy
Aim to select the drug within a treatment class
which will be safest to the fetus, least risk drug
at lowest effective dose
Patient education – Risk versus benefit, ADR’s
Appropriate medication use – Safer medications
and get patient to goal
Pregnancy Exposure Registry
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Prospective observational study
Collects information on medications and
vaccinations taken during pregnancy
Registries available at
http://www.fda.gov/womens/registries/d
efault.htm
Requires patient interviews
Questions???