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    029240

    Despite court ruling, experts insist spermicides are safe.

    Contraceptive Technology Update. 1985 Mar; 6(3):37-9.

    Recently in Atlanta, Georgia, a US District Judge, Marvin Shoob, ordered Ortho Pharmaceutical Corporation to pay US$5.1 million in damages to a 3 year old girl, born with birth defects to a women who used a spermicide, manufactured by Ortho, when the child was conceived and for 4 weeks following conception. The child was born with a missing left arm, missing fingers on the right hand, a cleft palate, and impaired hearing. The spermicide, Ortho-Gynol, contains octoxynol, which prevents pregnancy by destroying the outer layer of sperm cells. The judge maintained that Ortho was negligent for failing to attach a label to the spermicide warning users that birth defects could occur if the product was used during pregnancy. In 1983, a Food and Drug Administration (FDA) advisory committee advised drug companies that is was unnecessary to attach such a label. The chairman of the committee, Ronald W. Nelson, still maintains that a warning label is unwarrented. "Contraceptive Technology Update" spoke with a number of family planning practitioners and several experts, including some who were involved in the case, concerning their views about the case. Most of the partitioners expressed surprise about the ruling, indicated that they did not plan to alter their counseling advise concerning spermicides, and believed that a warning label was not warranted. A representative for Ortho stated that the company still believes that there is no link between birth defects and the use of spermicides. Ortho does not plan to use a warning label. A spokesman from the judge's office said that the ruling pertained only to the specific case, and that the decision was not generalizable. Robert L. Brent, an expert witness for Ortho said that studies failed to find a significant association between birth defects and spermicides; however, he noted that researchers did not rule out the possibility that there was a slightly increased risk of birth defects among infants born to women who used spermicides. Bruce Buehler, an expert witness for the plaintiff, said that there was a probable link between the spermicide and the missing arm defect and a possible link between the spermicide and the missing fingers. He said that the damage probably occurred at some crucial developmental stage during the 4 weeks following conception rather than at the time of conception. A proponent for labeling is Herschel Jick. He and his colleagues conducted a study in 1981 of 763 women, who had prescriptions for spermicides filled within 600 days of pregnancy outcome, and of 3902 nonusers. 2.2% of the users, compared to 1.1% of the nonusers gave birth to infants with birth defects. The study has been criticized by experts for failing to isolate a well-defined syndrome among infants born to spermicide users and for failing to determine if and when those identified as users actually did use the prescribed spermicides. Jose Cordero of the Center for Disease Control noted that the Center does not have an official position concerning the issue, but that he did not feel that the evidence was strong enough to support claims of an association.
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