Teratogenicity of Drugs Most Commonly Used in Pregnancy

Medications taken to treat coughs and colds, which are primarily available without prescription, are among the most commonly used medicines in pregnancy, but the safety of these products with respect to birth defects is not established. Recent data have suggested that some of these medicines may be hazardous to young children, and particularly infants, but little attention has been devoted to studying their risks and safety to the fetus. Given the wide use of these drugs, even a small increase in the risk of birth defects may have considerable clinical and public health implications. This study will take advantage of data already collected by the Pregnancy Health Interview Study (Birth Defects Study), a large ongoing multicenter case-control surveillance program of birth defects in the North America ,to evaluate the risks and safety of these medicines in relation to 1) specific malformations previously suggested to be associated with some of them, and 2) specific malformations that occur most commonly in the general population. In addition, we are evaluating other commonly used medications by systematically screening each of them in relation to the risk of specific malformations.

This study will take advantage of data already collected by the PHIS/BDS, a large ongoing multicenter case-control surveillance program of birth defects in the North America . The BDS identifies infants with a wide range of malformations, as well as non-malformed infants, at referral and birth hospitals. Within 6 months of delivery, study nurses interview mothers about demographic, reproductive, and medical factors; medication and vitamin use; cigarette smoking and alcohol consumption; and dietary intake.

Since the medications under study represent the ones most commonly taken by pregnant women, the findings from this focused analysis will be of importance to pregnant women and their health care providers.

Investigators:

Allen A. Mitchell, M.D., Principal Investigator
Sonia Hernández-Díaz, M.D., Dr.P.H., Co-Principal Investigator
Martha M. Werler, Sc.D., Co-Investigator
Carol Louik, Sc.D., Epidemiologist
Carla van Bennekom, M.P.H., Epidemiologist

Study Staff:

Dawn Jacobs, R.N., M.P.H., Project Coordinator
Fiona Rice, M.P.H., Program Coordinator
Nastia Dynkin, Computer Programmer
Christina Coleman, P.A., Research Coordinator

Nurse Interviewers:

Clare Coughlin, R.N.
Moira Quinn, R.N.
Kathleen Sheehan, R.N.
Laurie Cincotta, R.N.
Susan Littlefield, R.N.
Laine Fletcher, Interpreter
Ileana Gatica, Interpreter
Monica Martinez-Dale, Interpreter

Research Assistants:

Joan Shander
Julia Venanzi
Mark Abcede
Judy Jean, R.N.
Gabrielle Fortier
Casey Braddy

Source of Funding:

National Institute of Child Health and Human Development

Study Period:

2005 to 2013

Dawn Jacobs, R.N., M.P.H., Project Coordinator
(617) 734-6006

Participant Information:

(866) 896-1097 (toll free-bilingual English/Spanish line)