Drug Transfer Into Breast Milk and Interpretation of Data

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
(No Transcript)
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
RegulatedbyFDA
NoFDAGuidance
Human milk is made for human infants. It meets
all their specific needs. - FDA Consumer, Sept
1998
5
Medications in Breast-Feeding Mothers
BenefitsofMedicationforMother
Sources of Information internet resources, 11
consultations, periodicals
6
http//www.perinatology.com
All were rated Compatible with breast-feeding!
7
Medications in Breast-Feeding Mothers
BenefitsofMedicationforMother
Sources of Information internet resources, 11
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 FDAs 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 NDAs 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