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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.
[Unpublished] 1984. i, 17 p.On March 8, 1984, a group of experts was assembled by the American Public Health Association (APHA) to discuss oral contraceptive (OC) needs of developing countries. The group reviewed current information on OC clinical trial performance, lipid effects, potency/dosage issues, relationship to female reproductive cancers, specific developing country concerns, and various programmatic issues. Particular concern was voiced about the need to try to avoid OC formulation switching in developing country programs since this can have significant adverse effects. Because of logistical difficulties, many developing country programs have difficulty suppling more than 1 OC. Recommendations for minimizing this continuity problem include: 1) providing a single predominant OC for most developing country programs; 2) engaging in multiple-year procurements; and 3) attempting to continue to provide a particular formulation in special circumstances where it has a high proprietary and/or continuity value, (e.g., social marketing programs). Some 30-35 ug estrogen OCs currently available in the US appear to perform in clinical trials at roughly the same general acceptable level as the 50 ug estrogen OCs. Accordingly, there was a general consensus among the group that a single predominant pill should be selected from among these particular 30-35 ug estrogen OCs. At the same time, it was clearly not the group's intent to recommend limiting OCs provided to developing countries to this particular set. Based on concern about human variability, contraceptive efficacy, program continuity, and the desires of developing countries themselves, another list of formulations was also considered suitable. (author's modified)
In: Morris LA, Mazis MB, Barofsky I, ed. Product labeling and health risks. [Cold Spring Harbor, New York], Cold Spring Harbor Laboratory, 1980. 23-36.This paper evaluates the communication value of the federally required oral contraceptive (OC) and estrogen patient package inserts (PPIs). PPIs are required to be made available to users of certain prescription drugs, in particular, OCs and estrogen drugs to enable consumers to make informed choices about the drug. In the case of the OCs, PPI was required because OCs are used by healthy women for nontherapeutic purposes and are associated with serious risks (e.g., fatal blood clots). Originally, it was required that 2 types of printed materials be made available to patients: a relatively brief insert (9 sentences of information) and a longer brochure (22 paragraphs) to be dispensed by the physician upon patient request. A national survey of the Food and Drug Administration (FDA) in 1975 to evaluate the effects of the PPI and brochure on consumer behavior revealed high levels of reported receipt and readership. Another finding showed that people tended to remember what they considered the most important information about OCs, but were unable to identify the contents of specific sections of the insert. The survey was unable to determine to what degree or manner the PPIs affected decision making of the consumer. The FDA survey resulted in lengthening of the brochure and the insert to include new information about cardiac and cancer risks. In addition, it is now required that both brochure and insert be dispensed to the patient. With respect to estrogen PPIs, the PPIs were required by the government in 1977 to accompany estrogen drugs after epidemiological studies indicated an increased risk of endometrial cancer with prolonged usage of the drug. The estrogen PPI was 35 paragraphs long and frankly discussed the dangers and risks associated with estrogen. Critics maintained that such warnings merely served to frighten women without improving the quality of care or patient decision-making. Data regarding the effects of estrogen PPI are presently limited. Studies are being done to evaluate its effects on patient decision making. On a gross measure of retail sales, however, a decrease of use of estrogen has been observed. Jick (1979) reported a 27% decline in endometrial cancer from 1975 to 1977. The role of PPI in this decline however is not known. Further research should be done to determine more fully the effects of PPIs on patients' level of knowledge about prescription drugs and on their decision-making process.
Contraception. 1981 Oct; 24(4):323-39.A contraceptive vaginal ring containing levonorgestrel and estradiol was designed in which the drug is located in a 0.15 mm layer beneath a 0.25 mm overcoat at the ring's surface which controls the rate of steroid release. This design has been termed the "shell" ring. In vitro studies were carried out on the shell ring and also on 2 types of rings of earlier design, a homogenous ring and a shell ring without the rate-controlling overcoat. Levonorgestrel and estradiol were released in vitro at a constant rate of about 500 mcg/day and 300 mcg/day respectively, from shell rings of 9.2 mm cross-sectional diameter and 58 mm overall diameter. In the other 2 types of rings, a burst of steroid release was seen followed by a rapid fall in diffusion rates. Individual shell rings were used in clinical trials for 6 or 7 consecutive 21 day cycles with a 7 day nonuse interval between cycles. At the end of the study, they were returned to allow analysis and calculation of average steroid loss in vivo. In vivo, rings of 58 mm diameter were found to release levonorgestrel and estradiol at rates of 293 + or - 54 mcg/day and 183 + or - 34 mcg/day, respectively. Rings of 50 mm diameter had levonorgestrel and estradiol release rates of 252 + or - 34 mcg/day and 152 + or - 21 mcg/day, respectively. The release characteristics of the shell ring are such that it is expected to find a role in fertility control. All the studies reported in this issue of Contraception have used the same design of shell ring. (author's)
American Pharmacy. 1981 Jun; 21(6):38-41.There are an estimated 8.4 million women today in the U.S. using combined OCs (oral contraceptives). The estrogen component of OCs can either be mestranol or ethinylestradiol. Formulations with high doses of estrogen are thought to be responsible for most of the side effects related to OCs, i.e. myocardial infarction, venous thrombosis, and thrombotic or hemorrhagic stroke. OC users are 3 times more likely than nonusers to have a fatal heart attack. In women who smoke or who are hypertensive, who have diabetes or high cholesterol levels, or who are in advanced age, the risk increases. High-dose estrogen formulations also seem to increase cholesterol and triglycerides levels, and suppress insulin after about 2 years of use. The use of ampicillin, rifampin or tetracycline may interfere with the contraceptive effect of the formulation. A recent longitudinal study conducted in Walnut Creek, California, concluded that OCs are safe for young, white, middle-class American women. It also noted an increased incidence among users of lung cancer, cervical cancer and malignant melanoma, and attributed these findings to higher rates of smoking, sexual activity, and sun exposure. There are not any postcoital drugs on the market today which are approved by the FDA. DES (diethylstilbestrol) is widely used as an antidote to unprotected intercourse; 25 mg are taken twice a day for 5 days, starting within 72 hours of coitus. The FDA has never been able to induce manufacturers to label the drug noting the severe side effects it can cause. High dosage ethinyl estradiol and conjugated estrogen are also used as postcoital contraceptives. ERT (estrogen replacement therapy) has been proven to increase risk of endometrial cancer, and it does alleviate vasomotor sequelae and vaginal atrophy and dryness. The value of ERT in retarding osteoporosis is still a controversial matter. The FDA and most gynecologists recommend prescribing the lowest dose of estrogen for the shortest time possible in patients for whom alleviation of postmenopausal symptoms by ERT seem warranted. The use of subcutaneous implant of estradiol pellets in the treatment of menopause-related vasomotor symptoms and for contraceptive purposes is currently being investigated.
FDC Reports. Drugs and Cosmetics. 1980 Oct 27; 42(43):T and G-8.The Fertility and Maternal Health Drugs Advisory Committee recently recommended the continued marketing of all current OC (oral contraceptives) doses on the market. It also recommends the revision of the labeling caution on "dose-related risk of thromboembolism from OC" to "studies have shown a possible (substituted for 'positive') association between the dose of estrogen in OCs and risk of thromboembolism". A cautionary statement on patient package labeling should indicate to the patient that doubling dose or side effects of breakthrough bleeding will result in higher amounts of estrogen. The recommendations were based on a review of high dose OC studies presented by Boston University. The review failed to conclusively establish the claim that higher dose estrogens are less safe than those containing smaller amounts of estrogen. Cited were the major findings of the Walnut Creek Contraceptive Drug Study, the most comprehensive prospective investigation of American OC users. The findings suggest that: 1) there is no evidence of an increase in risk of cancer of breast, endometrium or ovary associated with OC use; 2) OC use in itself does not increase risk of cervical cancer; 3) OC users who do not smoke do not have any increase in risk from circulatory disease; and 4) increase in risk of malignant melanoma of skin was associated with OC users of all ages.
(FDA to require distribution of brochure explaining the benefits and risks of the hormone estrogen) (Press release)
Washington, D.C., USDHEW, October 17, 1977. 3 pEffective 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.