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.
|Journal||Journal of Population Therapeutics and Clinical Pharmacology|
|State||Published - 2010|
Bibliographical noteFunding Information:
Receivd 2e5 February 1999; accepted 23 September 1999. The authors are grateful to Prof. A. K. Ghatak and Prof. I. C. Goyal for useful discussions and suggestions. This work is supported by a collaborative project sponsored by the Indo-French Centre for the Promotion of Advanced research (IFC PAR)/Centre Franco-Indien pour la Promotion de la Recherche Avceea(CnEFIPR A), New Delhi through the Indo-French collaborativpreoject on “R&D in Dispersion Compensating and Erbium Doped Fibers.” Address correspondence to R. K. Varshney, Department of Physics, Indian Institute of Techol-n ogy, Hauz Khas, New Delhi 110 016, India. E-mail: email@example.com. in