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    052431

    Letter to the editor concerning "Labeling Guidance for Combination Oral Contraceptives" [letter]

    Sturtevant FM

    CONTRACEPTION. 1988 Dec; 38(6):725-7.

    The Food and Drug Administration's Labeling Guidance for Combination Oral Contraceptives," published in the May 1988 issue of "Contraception," contains errors and omissions. Under "Indications and Usage" in Table I the lowest expected failure rates should be 2 for condom without spermicides, 2-10 for periodic abstinence, and .2 for female sterilization. Under "Contraindications" coronary artery disease and myocardial infarction should be listed, as infarction can occur with normal-appearing arteries in young women. Other liver neoplasms, e.g., hamartomas, focal nodular hyperplasias, a peliosis hepatis should be included. Under "Warnings" it should be noted that case-control studies measure odds ratios, not incidence; cohort studies measure incidence. Also, mortality increases in non-smokers over 45, not 40. Under "Thromboembolism" the references cited (9 and 26) contain no information about postoperative thromboembolism, and the statement that risk "disappears after pill use is stopped" is inconsistent with the section on "Persistence of Risk." There are several questionable citations of Reference 29 in support of cerebrovascular diseases. Under "Precautions" several additional interacting drugs should be included, and the phrase "sex-steroid binding" should replace "sex-binding." Under "Non-Contraceptive Health Benefits" the findings of case-control studies should be described as "risk" rather than "incidence." Under "Other Conditions" associated with oral contraceptive use, at least 16 other conditions should be included. Finally, the "Labeling Guidance" is only a Food and Drug Administration guide; it should not be used as a substitute for the labeling provided by the manufacturer of the specific oral contraceptive.
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