Postmarketing surveillance for drug safety in pregnancy: the Organization of Teratology Information Services project.
BACKGROUND
Although medications are frequently used during pregnancy, premarketing studies exclude pregnant women, with the result that maternal and fetal risks of medications are largely unknown prior to marketing.


METHODS
To demonstrate the feasibility of using Teratology Information Services (TISs) to identify potential subjects who may participate in postmarketing surveillance studies regarding medications taken during pregnancy, maternal characteristics and pregnancy exposure data routinely collected from callers to member agencies of the Organization of Teratology Information Services (OTIS) were pooled for two one-month periods.


RESULTS
A total of 3536 calls inquiring about 7746 different agents were received from pregnant women. Of the 40 medications about which pregnant women most frequently asked, the top two were nonprescription acetaminophen and pseudoephedrine, three were prescription drugs with a U.S. Food and Drug Administration pregnancy label category D designation, and five were prescription antidepressants.


CONCLUSIONS
TISs are well positioned to prospectively ascertain medication exposures in large numbers of pregnant women and may be an exceptional resource for conducting postmarketing surveillance for the safety of medications taken during pregnancy.
Felix
Robert J
RJ
California Teratogen Information Service and Clinical Research Program, Department of Pediatrics, University of California San Diego, La Jolla, CA 92103, USA.
Jones
Kenneth Lyons
KL
Johnson
Kathleen A
KA
McCloskey
Carolyn A
CA
Chambers
Christina D
CD
D000014:Abnormalities, Drug-Induced / Q000209:etiology* / Q000517:prevention & control*; D000328:Adult; D003625:Data Collection; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D015277:Hotlines; D006801:Humans; D007255:Information Services; D018579:Patient Selection; D011247:Pregnancy; D011248:Pregnancy Complications; D011358:Product Surveillance, Postmarketing; D012449:Safety; D013723:Teratogens / Q000633:toxicity
D013723:Teratogens