title: Postmarketing surveillance for drug safety in pregnancy: the Organization of Teratology Information Services project.
abstract: 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.
authors.affiliation: California Teratogen Information Service and Clinical Research Program, Department of Pediatrics, University of California San Diego, La Jolla, CA 92103, USA.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Felix
authors.forename: Kenneth Lyons
authors.initials: KL
authors.lastname: Jones
authors.forename: Kathleen A
authors.initials: KA
authors.lastname: Johnson
authors.forename: Carolyn A
authors.initials: CA
authors.lastname: McCloskey
authors.forename: Christina D
authors.initials: CD
authors.lastname: Chambers
mesh_terms: 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
chemical_list: D013723:Teratogens