1. Jim Mahowald, Pharm.D. Clinical Coordinator St. Cloud Hospital Inpatient Pharmacy January 2013

2. Objectives Review a brief history of medications and breastfeeding List resources that are helpful with medications and breastfeeding Detail how to use a pharmacist as a reference Present cases showing how medication issues arise © 2013 CentraCare Health System

3. Breastfeeding and Medications: History 150 AD Soranus told wet nurses to refrain from drugs/alcohol 1930’s – 1960’s dramatic 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/toxicity Answers not always apparent © 2013 CentraCare Health System

4. Parlodel Post Partum – Not Anymore Bromocriptine 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 The indication for use of bromocriptine for inhibition of postpartum lactation was withdrawn based on postmarketing reports of stroke in this setting; therefore, do not use bromocriptine during lactation in postpartum women © 2013 CentraCare Health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

5. Breastfeeding and Medications: Why Breast milk possesses nutritional and immunologic properties superior to infant formulas American Academy of Pediatrics Position paper stating breastfeeding as the best nutritional mode for infants for the 1 st 6 months of life Studies suggest significant psychologic benefits of breastfeeding for mother and infant © 2013 CentraCare Health System

6. Breastfeeding and Medications: Issues Seldom absolute answers New drugs – not studied in these patients Risks change during breastfeeding Neonate and very young at most risk Nearly all reported adverse effects have occurred in infants < 6 months old Recommendations based on toxicity data for adults in most cases © 2013 CentraCare Health System

7. Medications and Breastfeeding Individual susceptibility May differ from safety data in large population Data 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 taking Do not take without good cause © 2013 CentraCare Health System

8. References Available Drugs in Pregnancy and Lactation (Briggs) Micromedex Up to Date Pharmacist’s Letter Phamacists © 2013 CentraCare Health System

9. Drugs in Pregnancy and Lactation (Briggs) In print for 25 years 1200 medications citations 90 agents listed as “teratogenic” New and old medications Reviews are “exhaustive” Assess the risk at different stages of development Embryo Fetus Nursing infant © 2013 CentraCare Health System

10. Drugs in Pregnancy and Lactation (Briggs) Monographs Introduction Animal Reproduction Data Placental Transfer Reports of Human Pregnancy Exposure Summary Important distinction: excretion into milk vs. effects on nursing infant May include telephone # to join observational study © 2013 CentraCare Health System

11. Drugs in Pregnancy and Lactation (Briggs) Provides tables with concentration of the medication in breast milk Milk: plasma ratio Significance: drug in present, not meant for advice Do not know Maternal dose Frequency of dose Time of administration to sampling Frequency of nursing © 2013 CentraCare Health System

12. Drugs in Pregnancy and Lactation (Briggs): Definitions Compatible: 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. Examples Acetaminophen Acyclovir Ibuprofen Warfarin © 2013 CentraCare Health System

13. Drugs in Pregnancy and Lactation (Briggs): Definitions Hold 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 Acid Metronidazole (single dose) © 2013 CentraCare Health System

14. Drugs in Pregnancy and Lactation (Briggs): Definitions No (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: Albuterol Naproxen Ondansetron © 2013 CentraCare Health System

15. Drugs in Pregnancy and Lactation (Briggs): Definitions No (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: Omeprazole SSRI’s: Paxil, Prozac, Zoloft © 2013 CentraCare Health System

16. Drugs in Pregnancy and Lactation (Briggs): Definitions No (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

17. 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: Chemotherapy Cigarettes Drugs in Pregnancy and Lactation (Briggs): Definitions © 2013 CentraCare Health System

18. On-Line Databases via Centranet Micromedex Facts and Comparisons Pharmacist’s Letter © 2013 CentraCare Health System

19. References Pharmacist Training 4 year degree Pharmacology/Therapeutics Curriculum Drug Information rotations Continuing Education Hospital / Community based practice sites © 2013 CentraCare Health System

20. Opportunities Pharmacy profession still has little involvement with pregnant patients There 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

21. Patient Case 24 y/o female presents with cellulitis Currently breastfeeding 2 month old male Prescribed Doxycycline 100 mg PO BID Appropriate? © 2013 CentraCare Health System

22. Patient Case 33 y/o female with h/o hypercholesterolemia not controlled by diet alone Breastfeeding and primary provider want to start lipid lowering therapy Statin a good choice? © 2013 CentraCare Health System

23. Conclusions Providers need to be aware of animal study results More study is needed Decision should be individualized to the patient and illness Pharmacy is always available to help © 2013 CentraCare Health System