Toward improved pregnancy labelling.

Autor: Koren G; Motherisk Program, University of Toronto, Canada., Sakaguchi S, Klieger C, Kazmin A, Osadchy A, Yazdani-Brojeni P, Matok I
Jazyk: angličtina
Zdroj: Journal of population therapeutics and clinical pharmacology = Journal de la therapeutique des populations et de la pharmacologie clinique [J Popul Ther Clin Pharmacol] 2010 Fall; Vol. 17 (3), pp. e349-57. Date of Electronic Publication: 2010 Oct 26.
Abstrakt: Information about the use of a medication in pregnancy is part of overall drug labelling as prepared by the pharmaceutical company and approved by the regulators. It is aimed at assisting clinicians in prescribing, however, very few drugs are labelled for specific indications in pregnancy, since there is rarely information about the use of a drug in this condition. Recently the FDA has drafted new guidelines for the labeling of drugs in pregnancy and breastfeeding, to replace the A,B,C,D,X system that was used for more than 30 years. Here we document the use of the new system through 3 different medications; each representing a different clinical situation in pregnancy--acute infection, chronic pain, and drug use during labor. Advantages and challenges in the new system are being highlighted.
Databáze: MEDLINE