TY - JOUR
T1 - Off-label prescribing in pregnancy
T2 - A case of risky business or business as usual?
AU - Grzeskowiak, Luke E.
AU - Mol, Ben W.
PY - 2015/4
Y1 - 2015/4
N2 - The licensing of medications for use in pregnancy represents a double edged sword in need of urgent attention. While product licences are important in instilling some sense of confidence that a medication meets stringent tests of efficacy and safety in the management of a specific condition in a specific population, they remain subject to significant limitations and biases. Given the commercial nature of the pharmaceutical industry, many would consider that product licensing is not just solely reflective of a medication passing a regulatory benefit-risk analysis, but also a more stringent internal profit-loss analysis.
AB - The licensing of medications for use in pregnancy represents a double edged sword in need of urgent attention. While product licences are important in instilling some sense of confidence that a medication meets stringent tests of efficacy and safety in the management of a specific condition in a specific population, they remain subject to significant limitations and biases. Given the commercial nature of the pharmaceutical industry, many would consider that product licensing is not just solely reflective of a medication passing a regulatory benefit-risk analysis, but also a more stringent internal profit-loss analysis.
KW - medications during pregnancy
KW - medico-legal concerns
UR - http://www.scopus.com/inward/record.url?scp=84925666493&partnerID=8YFLogxK
U2 - 10.1016/j.ejogrb.2015.01.001
DO - 10.1016/j.ejogrb.2015.01.001
M3 - Editorial
C2 - 25637427
AN - SCOPUS:84925666493
SN - 0301-2115
VL - 187
SP - 78
EP - 79
JO - European Journal of Obstetrics & Gynecology and Reproductive Biology
JF - European Journal of Obstetrics & Gynecology and Reproductive Biology
ER -