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    020215

    Spermicide product warning for use by women who may be pregnant.

    Fdc Reports. Drugs and Cosmetics. 1981 Jul 11; 45(28):T and G-1.

    Spermicide product warning for use by women who may be pregnant is being considered by FDA, Deputy Com. Mark Novitch noted in a June 29 letter to Rep. Weiss (D-NY). In response to Weiss' inquiry about the potential teratogenicity of nonoxynol-9, in the VLI Today 24-hour contraceptive sponge, Novitch said that evidence indicates that the ingredient "is not teratogenic." Novitch added that "we are, however, currently considering a special warning concerning the use of any spermicides by women who suspect they may be pregnant." Novitch pointed out that FDA "has previously considered the possible modes by which spermicides could have a teratogenic effect, if such an effect exists. These modes include an effect on the developing ovum, sperm passing through a sublethal concentration of spermicide, fertilized ovum, and developing embryo." He added, however that "while all could perhaps be regarded as theoretically possible modes of teratogenesis, it is not easy to see how effects on the sperm would lead to teratogenicity, a developmental, not genetic, abnormality." Novitch's explanation of the agency's overall thinking regarding the use of spermicides in women who may be pregnant was in response to a specific question from Weiss on the safety of the Today product. Weiss has asked FDA 23 separate inquiries concerning the safety of Today ("The Pink Sheet" July 4, p.8). In another question to FDA on Today, Weiss maintained that the product is potentially carcinogenic, mutagenic, and teratogenic. He asked why the agency did not require that consumers of the OTC product be advised of the risks in the package insert. Novitch replied that FDA does "not feel that the product is carcinogenic and mutagenic," but he repeated that the agency is considering a teratogenicity statement for all spermicidal products. (full text)
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