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Vaginal Spermicides and Congenital Disorders: The Validity of a Study

Richard N. Watkins, MD
JAMA. 1986;256(22):3095. doi:10.1001/jama.1986.03380220061018.
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To the Editor.—  In April 1981, an article by Jick et al,1 of which I was a coauthor, suggested that a mother's exposure to spermicide "near the time of conception" might cause certain birth defects. Our article was not corroborated by subsequent studies.2 An expert panel assembled by the Food and Drug Administration found our study unpersuasive because of poor design and unsupported by well-designed studies (Proceedings of the Fertility and Maternal Health Drugs Advisory Committee, unpublished transcript. Food and Drug Administration, Dec 15, 1983). It is the purpose of this letter to allay further long-persisting concern generated by our article by showing that it was based on an inaccurate presumption of exposure to spermicide near the time of conception.In our study, a mother was "presumed to have used vaginal spermicides near the time of conception" if she had received a prescription for spermicides within 600 days

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