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Drug Transfer Into Breast Milk and Interpretation of Data

Drug Transfer Into Breast Milk and Interpretation of Data. Lawrence J. Lesko Office of Clinical Pharmacology and Biopharmaceutics Center for Drug Evaluation and Research Advisory Committee for Pharmaceutical Sciences Rockville, Maryland July 20, 2001. Virgin of the Green Cushion Paris.

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Drug Transfer Into Breast Milk and Interpretation of Data

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  1. Drug Transfer Into Breast Milk and Interpretation of Data Lawrence J. Lesko Office of Clinical Pharmacology and Biopharmaceutics Center for Drug Evaluation and ResearchAdvisory Committee for Pharmaceutical SciencesRockville, Maryland July 20, 2001

  2. Virgin of the Green CushionParis StatueMadrid StampHavana HHS ReportUnited States

  3. Demographics: 1998 • 61 million • number of women between 15-44 yrs of age • 4 million • number of newborn infants • 65% • fraction of infants who breastfeed • 2.6 million • number of potential recipients of unwanted drug “residues”

  4. Breast Milk or Formula: Making the Right Choice for Your Baby NoFDAGuidance RegulatedbyFDA “Human milk is made for human infants. It meets all their specific needs.” - FDA Consumer, Sept 1998

  5. RisksofMedicationtoInfant Medications in Breast-Feeding Mothers BenefitsofMedicationforMother Sources of Information: internet resources, 1:1 consultations, periodicals

  6. Acyclovir excretion into milk is concentratedAlbuterol excretion into milk is negligibleAminoglycosides most excreted into milkAmitriptyline excreted into milk but effects on infant are unknown, may be of concernCaffeine excreted into milk but acceptable when not used excessively http://www.perinatology.com All were rated “Compatible” with breast-feeding!

  7. RisksofMedicationtoInfant Medications in Breast-Feeding Mothers BenefitsofMedicationforMother Sources of Information: internet resources, 1:1 consultations, periodicals

  8. “The dairy industry has a profound interest in producing high quality products free of antibiotic residues. Antibiotic residues in milk are a food safety concern to FDA’s Center for Veterinary Medicine.”- http://www.fda.gov/cvm “Antibiotics are widely used in veterinary practice for therapeutic purposes. Screening is often the first line of food safety monitoring for the presence of these drugs in milk.”- FDA Veterinarian, Sept/Oct, 1997

  9. Purpose of Discussion • Our responsibility as a regulatory agency • to identify and reduce the barriers related to medications which keep women from initiating or continuing to breastfeed their infants • major barrier is the paucity of reliable and comprehensive studies of drugs in breast milk • well-designed breast-milk studies in NDA’s are rare

  10. Purpose of Discussion (Cont.) • To encourage improvements in the science of drug development • to provide data on the transfer of medications into breast milk and the potential risk to infants • to include more complete information in product labels related to breast milk • to empower woman, and their physicians, to make rational choices about benefits and risks

  11. Dr. Arzu Selen - background, issues and questions Dr. Shinya Ito - assessing drug transfer into breast milk Dr. Pat McNamara - clinical methods and issues related drug transfer into milk

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