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Women using spermicides need not fear fetal damage, experts agree.

Authors
Type
Published Article
Journal
Contraceptive technology update
Publication Date
Volume
6
Issue
4
Pages
65–66
Identifiers
PMID: 12313868
Source
Medline
Keywords
  • Americas
  • Congenital Abnormalities
  • Contraception
  • Contraceptive Agents, Female
  • Contraceptive Agents--Side Effects
  • Developed Countries
  • Developing Countries
  • Diseases
  • Evaluation
  • Family Planning
  • Neonatal Diseases And Abnormalities
  • North America
  • Northern America
  • Spermicidal Contraceptive Agents--Side Effects
  • United States

Abstract

The recent award of $5.1 million by an Atlanta federal court judge to a woman who had used vaginal spermicide, Ortho-Gynol, and subsequently had a deformed baby has stirred up a major controversy and alarmed thousands of women. The ruling held that the child's abnormalities resulted from the mother's use of the spermicide which damaged but did not kill the sperm. It further held that Ortho Pharmaceutical Corporation, the manufacturer, was at fault for not warning women that this product could produce birth defects. Established medical data reveal that 2-5% of babies are born with some form of birth defect. In most instances their mothers were not exposed to any agent known to cause birth defects, and the reasons for those events are never determined. The question of whether spermicides cause fetal abnormalities has been extensively evaluated. 1 evaluation was completed by the US Food and Drug Administration's (FDA) Panel on Vaginal Contraceptive Durg Products for Over-the-Counter Human Use. That panel met almost monthly from 1973-78 to evaluate the safety and efficacy of vaginal preparations. The evaluation included reviewing available information about the ingredients used in spermicides. The ingredent in question, octoxynol, was included in the review as well as nonoxynol-9, another widely used spermicidal agent. The panel reported that there is no evidence thus far which suggests that these ingredients produced any such damage. In the early 1980s 2 reports demonstrated a slightly increased risk of birth defects in children of women using spermicides, but those studies were poorly designed and their conclusions were not substantiated by later, more accurate, and carefully conducted evaluations. In 1983 the FDA's Fertility and Maternal Health Drugs Advisory Committee again reviewed the evidence and unanimously concluded that women using spermicides were not at increased risk of having babies with birth defects. Responding to the recent legal ruling, experts from the Centers for Disease Control, the National Institutes of Health, the FDA, the March of Dimes, and other scientists who specialize in studying birth defects have corroborated that the overwhelming weight of the current medical evidence fails to indicate that spermicides cause fetal damage. Overreaction to the decision can be most unfortunate. Consumers should be aware that the recent ruling runs directly counter to current medical expert opinion.

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