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  1. 1
    096206

    Estrogen dose in oral contraceptives: FDA committee examines safety and utility of 50 mcg estrogen OCs.

    CONTRACEPTION REPORT. 1994 Mar; 5(1):10-3.

    In July, 1993, the US Food and Drug Administration (FDA) sent a letter to manufacturers of oral contraceptives (OCs) to inform them about reports of reduced risk of thromboembolic events linked to OCs with less than 50 mcg estrogen, and to ask them to voluntarily withdraw 50 mcg OCs from the market. In October, 1993, FDA's Fertility and Maternal Health Drugs Advisory Committee met to discuss the relative safety and utility of OCs with 50 mcg estrogen. 15% of women at least 45 years old who were using OCs were taking OCs with 50 mcg estrogen. Some gynecologists justified continuation of the higher-dose OC in this age group by claiming that the high dose was needed to treat breakthrough bleeding, which in turn improves user compliance, continuation, and contraceptive effectiveness. Since rifampin, phenytoin, phenobarbital, griseofulvin, and (possibly) long-term use of tetracycline reduce contraceptive effectiveness, physicians prefer 50 mcg estrogen OCs for women taking them. One committee member was concerned with the number of 45-year-old or older women, who are at the greatest risk of a thromboembolic event, who use 50 mcg estrogen OCs without good cause. The committee's consumer representative considered this to be a physician education problem. A review of the literature showed no clear, significant increase in the risk of thromboembolic events in women who use 50 mcg OCs. One physician pointed out that continual reduction of the estrogen dose to eliminate the small or nonexistent cardiovascular risks reduces some benefits, especially protection against ovarian and endometrial cancers. Even though the committee did not unanimously agree that 50 mcg estrogen OCs are less safe than OCs with lower estrogen doses, they did agree to recommend more emphasis and prominence on current OC labeling about prescribing the smallest estrogen dose needed to achieve contraceptive efficacy.
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  2. 2
    775345

    (FDA to require distribution of brochure explaining the benefits and risks of the hormone estrogen) (Press release)

    United States. Food and Drug Administration [FDA]

    Washington, D.C., USDHEW, October 17, 1977. 3 p

    Effective October 18, 1977, women receiving prescriptions for drugs containing the female sex hormone estrogen must be given a special lay-language brochure explaining the benefits and risks of the drug. About 5,000,000 women in the U.S. use estrogen-containing prescription drugs every year to treat menopausal or postmenopausal problems. The brands prescribed include Premarin, Hormonin, Estratab, Evex, Menest, Femogen, and Ogen. Donald Kennedy, Commissioner of Food and Drugs, has stated that FDA has become increasingly concerned that estrogens are used too frequently and for too long a period. The brochure, to be printed and supplied by manufacturers of the drugs, indicates that estrogens are associated with cancer of the uterus when used for extended periods. Additionally, the brochure advises women to take estrogen drugs for the shortest time possible and in the lowest effective dose for treatment of menopausal systems and to reevaluate, with their doctors, the need for estrogen every 6 months. It states that these drugs should not be used to treat simple nervousness and depression during menopause because they have not been shown to be effective for these purposes and that they have not been shown to be effective for keeping the skin soft or for helping women feel younger after menopause.
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