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Jim Mahowald, Pharm.D.Clinical Coordinator
St. Cloud Hospital Inpatient PharmacyJanuary 2013
ObjectivesReview a brief history of medications and
breastfeedingList resources that are helpful with
medications and breastfeedingDetail how to use a pharmacist as a referencePresent cases showing how medication issues
arise
© 2013 CentraCare Health System
Breastfeeding and Medications: History150 AD
Soranus told wet nurses to refrain from drugs/alcohol
1930’s – 1960’sdramatic decline in % of American mothers
breastfeeding (80% down to 28%)Reduction in length of time breastfeeding
Today > 50%Subsequent increases in parent questions
about safety/toxicityAnswers not always apparent
© 2013 CentraCare Health System
Parlodel Post Partum – Not AnymoreBromocriptine is contraindicated in women
who are breast-feeding their children because bromocriptine inhibits lactation. The indication for use of bromocriptine for inhibition of postpartum lactation was withdrawn based on postmarketing reports of stroke in this setting; therefore, do not use bromocriptine during lactation in postpartum women
© 2013 CentraCare Health System
Breastfeeding and Medications: WhyBreast milk possesses nutritional and
immunologic properties superior to infant formulas
American Academy of PediatricsPosition paper stating breastfeeding as the
best nutritional mode for infants for the 1st 6 months of life
Studies suggest significant psychologic benefits of breastfeeding for mother and infant
© 2013 CentraCare Health System
Breastfeeding and Medications: IssuesSeldom absolute answersNew drugs – not studied in these patientsRisks change during breastfeeding
Neonate and very young at most riskNearly all reported adverse effects have
occurred in infants < 6 months oldRecommendations based on toxicity data for
adults in most cases
© 2013 CentraCare Health System
Medications and BreastfeedingIndividual susceptibility
May differ from safety data in large populationData from animals may/may not translate to
humans Milk composition different resulting in changes in
elimination Greatest concern: human milk pH vs. cow’s milk pH Thalidomide
Need to know all medications patient takingDo not take without good cause
© 2013 CentraCare Health System
References AvailableDrugs in Pregnancy and Lactation (Briggs)MicromedexUp to DatePharmacist’s LetterPhamacists
© 2013 CentraCare Health System
Drugs in Pregnancy and Lactation (Briggs)In print for 25 years1200 medications citations90 agents listed as “teratogenic”
New and old medicationsReviews are “exhaustive”Assess the risk at different stages of development
EmbryoFetusNursing infant
© 2013 CentraCare Health System
Drugs in Pregnancy and Lactation (Briggs)Monographs
IntroductionAnimal Reproduction DataPlacental TransferReports of Human Pregnancy ExposureSummary
Important distinction: excretion into milk vs. effects on nursing infant
May include telephone # to join observational study
© 2013 CentraCare Health System
Drugs in Pregnancy and Lactation (Briggs)Provides tables with concentration of the
medication in breast milkMilk: plasma ratioSignificance: drug in present, not meant for
adviceDo not know
Maternal doseFrequency of doseTime of administration to samplingFrequency of nursing
© 2013 CentraCare Health System
Drugs in Pregnancy and Lactation (Briggs): DefinitionsCompatible: either the drug is not excreted
in clinically significant amounts into human breast milk or its use during lactation does not or is not expected to, cause toxicity in a nursing infant.
ExamplesAcetaminophenAcyclovirIbuprofenWarfarin
© 2013 CentraCare Health System
Drugs in Pregnancy and Lactation (Briggs): DefinitionsHold Breast Feeding: the drug may or may not
be excreted into human breast milk, but the maternal benefit of therapy far outweighs the benefits of breast milk to an infant. Breastfeeding should be held until maternal therapy is completed an the drug has been eliminated (or reached a low concentration) from her system.
Examples:Aminocaproic AcidMetronidazole (single dose)
© 2013 CentraCare Health System
Drugs in Pregnancy and Lactation (Briggs): DefinitionsNo (Limited)Human Data – Probably
Compatible: either there is no human data or the human data are limited. The available animal or other data suggest that the drug does not represent a significant risk to a nursing infant.
Examples:AlbuterolNaproxenOndansetron
© 2013 CentraCare Health System
Drugs in Pregnancy and Lactation (Briggs): DefinitionsNo (Limited) Human Data – Potential
Toxicity: either there is no human data or the human data are limited. The characteristics of the drug suggest that it could represent a clinically significant risk to a nursing infant. Breastfeeding is not recommended.
Examples:OmeprazoleSSRI’s: Paxil, Prozac, Zoloft
© 2013 CentraCare Health System
Drugs in Pregnancy and Lactation (Briggs): DefinitionsNo (Limited) Human data – Potential Toxicity
(Mother): either there is no human data or the human data are limited. The characteristics of the drug suggest that breastfeeding could represent a clinically significant risk to the mother such as further loss of essential vitamins or nutrients. Breastfeeding is not recommended.
© 2013 CentraCare Health System
Contraindicated: there my or may not be human experience, but the combined data (including animal data if available) suggest that the drug may cause severe toxicity in a nursing infant, or breastfeeding is contraindicated because of the maternal condition for which the drug is indicated. Women should not breastfeed if they are taking the drug or have the condition.
Examples:ChemotherapyCigarettes
Drugs in Pregnancy and Lactation (Briggs): Definitions
© 2013 CentraCare Health System
On-Line Databases via CentranetMicromedexFacts and ComparisonsPharmacist’s Letter
© 2013 CentraCare Health System
ReferencesPharmacistTraining
4 year degreePharmacology/Therapeutics CurriculumDrug Information rotationsContinuing Education
Hospital / Community based practice sites
© 2013 CentraCare Health System
OpportunitiesPharmacy profession still has little
involvement with pregnant patientsThere is an unmet demand for pharmacy
services in the care of these patients. Opportunities to work with maternal-fetal
medicine in clinical research involving the drug therapy of pregnant or breastfeeding women.
© 2013 CentraCare Health System
Patient Case24 y/o female presents with cellulitisCurrently breastfeeding 2 month old malePrescribed Doxycycline 100 mg PO BIDAppropriate?
© 2013 CentraCare Health System
Patient Case33 y/o female with h/o hypercholesterolemia
not controlled by diet aloneBreastfeeding and primary provider want to
start lipid lowering therapyStatin a good choice?
© 2013 CentraCare Health System
ConclusionsProviders need to be aware of animal study
resultsMore study is neededDecision should be individualized to the
patient and illnessPharmacy is always available to help
© 2013 CentraCare Health System