The Institute of Medicine has identified the prevention of birth defects as one of six priorities for the nation's health1 because annually, 150,000 infants (3% of all U.S. births) are born with some form of physical or mental birth defect.2 While the causes of most birth defects remain unknown, certain medications are known to increase rates of birth defects. For example, isotretinoin has been identified as a particularly teratogenic medication.3 Despite the resources that have been invested in the iPledge program, it has not been able to significantly reduce rates of adverse pregnancy outcomes related to the use of isotretinoin.5 We therefore propose to develop and then rigorously evaluate new educational materials which can be used to inform women about the most effective ways to prevent birth defects caused by the use of certain medications. Specifically, we will (1) develop a package insert that provides clear recommendations regarding use of highly effective contraception in order to avoid medication-induced birth defects, and (2) evaluate the effect of the new package insert on women's contraceptive choices while using isotretinoin. Our hypothesis is that the new package insert and educational materials will significantly increase the proportion of women who use highly effective contraception while taking isotretinoin.

Public Health Relevance

Women who take medications that can cause birth defects need clear information about the most effective ways to avoid an unintended pregnancy. This study will develop and evaluate a package insert and educational materials that provide clear recommendations regarding use of highly effective contraception in order to avoid medication-induced birth defects.

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01FD004253-02
Application #
8538243
Study Section
Special Emphasis Panel (ZFD1-SRC (99))
Project Start
2011-09-15
Project End
2014-09-14
Budget Start
2012-09-15
Budget End
2013-09-14
Support Year
2
Fiscal Year
2012
Total Cost
Indirect Cost
Name
University of Pittsburgh
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
Werner, Carly A; Papic, Melissa J; Ferris, Laura K et al. (2014) Women's experiences with isotretinoin risk reduction counseling. JAMA Dermatol 150:366-71