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ORAL CONTRACEPTIVE LABELING BREAST CANCER BOX WARNING

Executive Summary

ORAL CONTRACEPTIVE LABELING BREAST CANCER BOX WARNING is urged by Public Citizen's Health Research Group (HRG) in a Feb. 28 citizens petition to the agency. "We petition you...to require that all oral contraceptive labels for patients and doctors contain a box warning stating the possibility of an increased risk of developing breast cancer with OC [oral contraceptive] use," HRG stated. The petition included a proposed label warning. * The petition reacted to a conclusion reached by the Fertility and Maternal Health Drugs Advisory Committee at a Jan. 5-6, 1989 meeting that "the existing data do not support a change in prescribing practices or use of oral contraceptives" ("The Pink Sheet" Jan. 9, 1989, p. 13). The panel meeting had been called to review recent studies exploring the possible link between OC use and breast cancer. HRG's proposed labeling states: "Thirteen studies since 1977, eight since 1986, have reported an increased risk of breast cancer in some women who used oral contraceptives. Most of these concerned women who developed breast cancer under age 45." The label also cites three subgroups which have been reported to be at increased risk by at least two of the studies: "all women who used oral contraceptives for many years," as well as "women who used oral contraceptives for many years prior to having their first child...[or] prior to reaching age 25." The petitioners included one caveat in the recommended warning: "There is considerable debate on this issue, and these studies do not prove conclusively that oral contraceptives cause, or do not cause, breast cancer. Further studies to clarify the long-term risk of oral contraceptive use are in progress." Elaborating on this point in the body of the petition, HRG asserted, "as research and debate continue, women and physicians have a right to be informed of the possibility of an increased risk of breast cancer with OC use." Explaining the rationale behind the boxed warning, HRG cited two new studies that have been released since the advisory committee met last year. Those studies from England (Chilvers, et al.) and Sweden (Olsson, et al.) further support the possibility of an increased risk of breast cancer with oral contraceptive use, the petition contends. According to HRG, the Swedish study reported an elevated risk of breast cancer in women who started long-term use of oral contraceptives before age 25, as well as in women who reported long-term use of the pill before their first pregnancy. The English study reaffirms the relationship between breast cancer and long-term oral contraceptive use, HRG said. Although the proposed labeling acknowledges that "twenty reports on fourteen studies since 1980 have failed to demonstrate an increased risk of breast cancer in women who used oral contraceptives," it maintains: "most of these concerned women with little early long-term pill use." HRG maintains that three of the "negative" studies show a risk of breast cancer when "updated or refocused on women diagnosed with breast cancer before age 45." For example, the U.S. Cancer and Steroid Hormone Study (CASH) on premenopausal women aged 20-44 "was previously considered strong evidence against any association between OCs and breast cancer." A re-analysis of the data, however, identified non-childbearing women who experienced early menarche as a susceptible subgroup. * The citizen's petition also objected to FDA's Jan. 30 instruction to oral contraceptive manufacturers to delete mortality risk warnings for healthy, non-smoking women 40 years of age or older ("The Pink Sheet" Feb. 5, T&G-7). FDA issued the letter in response to an Oct. 26 recommendation by FDA's Fertility and Maternal Health Drugs panel to remove the warning: "Although cardiovascular disease risks might be increased from OC use in women over the age of 40, the Committee believes that the benefits of OC use outweigh such possible risks," the committee said ("The Pink Sheet" Oct. 30, p. 17).
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