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Volume 4, Issue 5 (Suppl) J Pharmacovigil 2016
ISSN:2329-6887 JP, an open access journal Pharmacovigilance Congress 2016
September 28-30, 2016
September 28-30, 2016 Toronto, Canada
6th Pharmacovigilance Congress
Faten Sabbagh, J Pharmacovigil 2016, 4:5 (Suppl)
Pharmacovigilance and compliance of drugs labeling information with the 2015 FDA Lactation
Guidelines
Faten Sabbagh
South College School of Pharmacy, USA
This study was conducted to evaluate published and manufacturer labeling information (PI) for commonly prescribed drugs
in the USA, and to examine compliance with the new 2015 FDA labeling guidelines. Data were also compared to the authors’
previously published information on the development of the first clinical classification of drugs used during lactation (FG-LA). Of
the top 200 drugs prescribed in 2015, 85% included a lactation section but information was limited and not in compliance with all
elements of FDA guidelines. Only 5% included risk versus benefits section, 54.5% were excreted into breast milk or included data on
milk-plasma ratio. Utilizing FG-LA clinical classification, 53.5% were clinically compatible with lactation but 19.5% caused mild to
moderate adverse effects on infants, and 1.5% caused mild to moderate adverse effects on the mothers. A total of 23.5% were classified
as incompatible with lactation, secretion of 11.5% was unknown, 6.5% caused mild to moderate adverse effects on infants and 1.5%
caused mild to moderate adverse effects on the mothers. A total of 23% were classified as unknown with compatibility and no data
on adverse effects were reported on infants or mothers. A total of 25.5% caused adverse effects on infants and 3% had adverse effects
on the lactating mothers. Several conflicts existed between data in the PI and the literature addressing secretion or concentrations
in breast milk. A firmer deadline is recommended by the FDA to drug manufacturers to update PI data in order to enhance patient
safety and therapeutic outcomes.
Biography
Faten Sabbagh is a PharmD Candidate at South College School of Pharmacy in Knoxville, Tennessee, USA. Her undergraduate study included Biological Sciences
at the University of Michigan-Dearborn and Henry Ford College. He has been in the practice of pharmacy since 2010 with certifications in Medication Therapy
Management, AHS-BLS, Immunization Delivery, Smoking Cessation, and Diabetes. Her areas of interest are Pharmacokinetics, Pharmacovigilance and Patient
Safety.