Toward improved pregnancy labelling.
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.
Motherisk Program, University of Toronto, Canada.
Gideon
G
Koren
Sachi
S
Sakaguchi
Chagit
C
Klieger
Alex
A
Kazmin
Alla
A
Osadchy
Parvaneh
P
Yazdani-Brojeni
Ilan
I
Matok
D000818:Animals; D001942:Breast Feeding; D004345:Drug Industry; D004348:Drug Labeling; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D017408:Guidelines as Topic; D006801:Humans; D007231:Infant, Newborn; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000145:classification*; D010818:Practice Patterns, Physicians' / Q000592:standards; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy*; D014481:United States; D014486:United States Food and Drug Administration
D004364:Pharmaceutical Preparations