Pharmacovigilance and compliance of drugs labeling information with the 2015 FDA lactation guidelines
6th Pharmacovigilance Congress
September 28-30, 2016 Toronto, Canada

Gamal Hussein

South College School of Pharmacy, USA

Keynote: J Pharmacovigil

Abstract:

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 :

Gamal Hussein is a Professor of Pharmacy and Director of Interprofessional Education. He has completed a Doctoral of Pharmacy and two Fellowships at the University of Texas and the University of California, San Francisco. His research led to the identification of therapeutic window for felbamate, topiramate and lamotrigine as well as the identification of drug reactions/interactions such as gabapentin-felbamate drug interaction, and propofol-induced dystonia. Tequin (gatifloxacin) was discontinued from the market after his and others’ findings on its potential to cause hypoglycemia. He received the “Innovation in Teaching” award from the American Association of Colleges of Pharmacy and the “Health-Systems Practitioner” award from the National Pharmaceutical Association.

Email: ghussein@southcollegetn.edu