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Abstract:
This Notice relates to oral contraceptive drug product labeling. It revises the "guideline texts of professional and patient labeling for estrogen-progestogen combination oral contraceptive drug products." This revision is being made to incorporate important new information about the benefits and risks of the use of such products. This information includes "evidence of a decreased incidence of benign breast disorders, functional ovarian cysts and pelvic inflammatory disease, as well as some evidence of protection against the development of ovarian and endometrial cancer. Additionally, oral contraceptive use has been reported to decrease the incidence of iron deficiency anemia and to decrease the incidence of dysmenorrhea".