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Contraception Report. 1999 Jan; 9(6): p..For the first time in the United States, emergency contraceptive pills carrying Food and Drug Administration (FDA)-approved labeling are commercially available. The specially-packaged product, the PREVEN Emergency Contraceptive Kit, contains four pills of a high-dose combination of ethinyl estradiol and levonorgestrel oral contraceptives (OCs). The product is for women who have had unprotected sexual intercourse within 72 hours of use who do not want to become pregnant. The high-dose method has been available in some other countries since the 1970s. Globally, the method is known as the Yuzpe regimen, postcoital contraception or the "morning-after pill." The regimen has been marketed in Europe since 1984. While some OCs have been used "off-label" for emergency contraception, routine use has been limited in the US. A survey commissioned by the Henry J. Kaiser Family Foundation of 2,002 US adults found that only 1% said they or their partners had used emergency contraception. A second survey of 307 obstetrician-gynecologists found that although about 70% said they had prescribed emergency contraception within the last year, 77% did so infrequently--five or fewer times. (excerpt)
AMERICAN JOURNAL OF PUBLIC HEALTH. 1993 Aug; 83(8):1094-9.More is known about the safety of oral contraceptives (OCs) than any other drug. 30 years of OC use show that they are safe. Some reproductive health specialists propose that OCs be available without a prescription. Obtaining a prescription keeps women from using this effective contraceptive because they need to make a costly initial clinic visit, undergo a pelvic examination, and periodic visits or telephone calls for refills, all of which are barriers to OC use. Women themselves can determine their need for OCs. They consider their risk of pregnancy and sexually transmitted diseases (STDs) and the costs and benefits of pregnancy and other contraceptives. Some people argue that OC users are more likely to receive preventive care services, such as STD screening, than are nonusers. Yet, men do not need an annual prescription for condoms to promote early detection of prostate and testicular cancer. This carrot (i.e., coercion) policy assumes that women cannot make their own decisions. Family planning clinics fear losing revenue if OCs were available without a prescription, but family planning providers need to be reimbursed for the primary prevention services they already provide and not for providing prescriptions to OCs. Improper compliance already exists even though women need a prescription to use OCs, so making OCs available over-the-counter will not effect user compliance. Some options to make OCs more accessible include a 28-day format packaging of OCs with comprehensible and legible labels including guidelines on compliance and key danger signals, an initial examination only, elimination of the pelvic examination, and counseling only for first-time users. Over-the-counter options could be a self-administered knowledge inventory maintained by pharmacists, a toll-free telephone authorization process a fax or mail-in order form, over-the-counter purchases for experienced users, and over-the-counter purchase with no restrictions.
[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)
Report of the Committee set up by the Executive of the Irish Medical Association to advise on the hazards and side-effects of ovulation suppressants.
Journal of the Irish Medical Association 71(2, Suppl.):1-10. February 17, 1978.Approximately 5% of the 48,000 women in the Republic of Ireland who use oral contraceptives were prescribed 1 of the 8 combined preparations which contain 75-100 mcg of estrogen. Since estrogen has been linked to the hazards of oral contraceptive use, all preparations prescribed or marketed in the Republic of Ireland should contain no more than 50 mcg of estrogen. The absolute and relative counterindications to oral contraceptive use are given as is a recommended supervision protocol for current users. Results of studies of cardiovascular mortality associated with oral contraceptive use are summarized, and mortality rates are compared with death rates from various other causes. The association between oral contraceptives and venous thromboembolism and hypertension is discussed as are the effects of this contraceptive method on subsequent fertility and pregnancy. Reasons for discontinuation of this method are explored, and carbohydrate and lipid metabolic changes are outlined. The effects of oral contraceptive use on the liver, the gall bladder, the breasts, the skin, the urogenital system, the eyes and vision, the oral cavity, and the use of certain drugs are reported. It is recommended that physicians receive full information on the contraindications, hazards, and side effects of oral contraceptives and that users be made award of these sequelae and of their symptoms via an explanatory package insert. The 24 preparations currently in use in the Republic of Ireland and their estrogen dosages are listed, and a sample of appropriate user information is given.
Press Release. Contact: Ed Nids, United States Food and Drug Administration, 5600 Fishers Lane, Rockville, Maryland, 20852. January 24, 1977. 7 p.Increased consumer demand for more oral contraceptive information prompted the FDA (Food and Drug Administration) as of April 3, 1978 to require, in pamphlet form, additional patient information on effectiveness rates and side effects of oral contraceptives along with a change in information physicians receive. A strong warning advising women not to smoke if taking the pill is emphasized along with the following pertinent facts: 1) Theoretical effectiveness for the combination pill is about 99% and about 97% for the progestogen only pill; 2) Contraindications include smoking; blood clotting; cancer of the breast or reproductive organs; stroke; heart attack and pregnancy. It is strongly advised that women with irregular of light menses not take the pill; 3) Serious side effects include blood clots, liver tumors, hemorrhages, birth defects, high blood pressure and gall bladder disease; while breakthrough bleeding, nausea, vomiting, weight gain, and breast tenderness are considered less serious; 4) Heart attack risks by nonsmoking women taking oral contraceptives are double, however, the risk is 10 times greater for those combining the pill with smoking; 5) Although current studies do not confirm a cause-effect relationship between estrogen, an ingredient in the pill, and cancer in humans, the relationship has been found in some animal studies; 6) venereal disease is not prevented or cured by oral contraceptives; 7) the onset of pregnancy should be delayed several months after stopping the pill. Donald Kennedy, FDA Commissioner, commented on the new requirements reiterating the dangerous effect of combining the pill with smoking.
Planned Parenthood-World Population Washington Memo W-3. 1977 Mar 1; 4-5.The British Joint Working Group on Oral Contraceptives, established to determine whether the present system of limiting oral contraception prescription to doctors inhibits women from obtaining effective contraceptive protection, has recommended that properly trained nonphysicians be allowed to prescribe the pill without direct physician supervision. A cadre of nurses, midwives, home health visitors, and pharmacists will be specially trained to advise patients on the risks and benefits of oral contraception. The Group's report notes that single women, especially teenagers, and some married women are unable or unwilling to approach their family doctor for contraceptive help. In the U.S., a Food and Drug Administration proposal to require an additional patient brochure as well as a package insert for the pill represents yet another new approach to protecting the health of oral contraception users. While in agreement with the concept of intensive patient education regarding the side effects and contraindications of the pill, Planned Parenthood has recommended several revisions in the brochure's content so as to achieve a greater balance of information on both benefits and risks and to reflect the most current scientific findings.
International Digest of Health Legislation 29(3):671-675. 1978In the United States there is a new requirement for labelling drugs that is directed to the patient. Regarding oral contraceptives (OCs) (Subsection (a) of Part 310 (New Drugs) of Subchapter D (Drugs for Human Use) of Chapter I (Food and Drug Administration, Department of Health, Education and Welfare) of Title 21 (Food and Drugs) of the United States Code of Federal Regulations, January 19, 1978), the Commissioner of Food and Drugs concludes that the safe and effective use of OCs requires that patients be fully informed of the benefits and risks involved in the use of these drugs. A brief summary of information in lay language concerning effectiveness, contraindications, warnings, precautions, and adverse reactions shall be furnished to each patient receiving OCs. Included in this brief summary provided to the patient by the dispenser is 1) a statement that OCs are effective, but that any failure to take them in accordance with the recommended dosage increases the chance of pregnancy; 2) a statement of the specific items of history to be told the physician that would lead the physician not to prescribe OCs; 3) a statement that OCs should be taken only under medical supervision; 4) a listing of the serious side effects of OCs; 5) a statement in the form of a boxed warning that cigarette smoking increases the risk of serious side effects on the heart and blood vessels from OC use, and advising women who use OCs not to smoke; and 6) a statement of the most common side effects, such as nausea and vomiting, weight change, change in menses, and breast tenderness.
Washington, D.C., U.S.F.D.A., September 17, 1975. 21 pOral contraceptive (OC) labeling requirements for estrogen-progestin preducts are presented. Changes in OC labeling for progestin only contraceptives cover effectiveness and warnings (bleeding irregularities ). OC labeling should include: a description of the drug and active ingredients, actions (effectiveness), indication, contraindications, warnings (increased risk to thromboembolic disease, carcinoma, hepatoma, use in pregnancy, gall bladder disease, metabolic effects, elevated blood pressure, bleeding irregularities, ectopic pregnancies and breast-feeding), precautions, adverse reactions observed in patients receiving OC, laboratory results that may be altered by OC use, overdosage, dosage and administration. Recommended for deletion were: how supplied animal pharmacology and toxicology, and information on clinical studies. If clinical data are included, a paragraph discussing clinical experience with regard to adverse reaction rates and pregnancy rates must be included.