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Such bleeding may be temporary and usually does not indicate any serious problems. Research Funding Opportunities. Inthe Fertility and Maternal Health Drugs Advisory Committee was asked to review the use of oral contraceptives in women 40 years of age and over. View Article Google Scholar 4. Contraceltives newsletter. Thromboembolism An increased risk of thromboembolic and thrombotic disease associated with the use of oral Oral contraceptives tm is well established.
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World Health Organization. Microgestin Fe 1. What side effects can this medication cause? Some of these products contain drospirenone, which has antimineralcorticoid. Cancer Biology Research. Annual Report to the Nation. Trivora - Tablets Phase 1: levonorgestrel 0. Risk Factors. Adapted with permission from Osterberg and Blaschke. New York: Oral contraceptives tm Books.
Generic Name: norethindrone and ethinyl estradiol Dosage Form: tablets.
- Oral contraceptives birth control pills are hormone-containing medications that are taken by mouth to prevent pregnancy.
- Written by C.
- The combined oral contraceptive pill COCP , often referred to as the birth control pill or colloquially as " the pill ", is a type of birth control that is designed to be taken orally by women.
- Although oral contraception OC misuse is presumed to play an important role in unwanted pregnancy, research findings have often been equivocal, perhaps reflecting unaddressed inconsistencies in methodological approaches.
Generic Name: norethindrone and ethinyl estradiol Dosage Form: tablets. Medically reviewed by Drugs. Last updated on Sep 1, Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including Nylia TM , should not be used by women who are over 35 years of age and smoke.
The following product is a combined oral contraceptive containing the progestational compound norethindrone and the estrogenic compound ethinyl estradiol. Inactive ingredients include anhydrous lactose, lactose monohydrate, magnesium stearate and pregelatinized starch maize. Each light peach tablet contains 0.
Each peach tablet contains 1 mg of norethindrone USP and 0. Their structural formulas are as follows:. Combined Oral Contraceptives Combined oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus which increase the difficulty of sperm entry into the uterus and the endometrium which reduce the likelihood of implantation.
Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. Correct and consistent use of methods can result in lower failure rates.
Oral contraceptives should not be used in women who currently have the following conditions:. The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors.
The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity and diabetes.
Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks. The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with higher formulations of estrogens and progestogens than those in common use today.
The effect of long-term use of the oral contraceptives with lower formulations of both estrogens and progestogens remains to be determined. Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, namely, a ratio of the incidence of a disease among oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease.
Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence of a disease in the population adapted from refs.
For further information, the reader is referred to a text on epidemiological methods. Thromboembolic Disorders and Other Vascular Problems a. Myocardial Infarction An increased risk of myocardial infarction has been attributed to oral contraceptive use. This risk is primarily in smokers or women with other underlying risk factors for coronary artery disease such as hypertension, hypercholesterolemia, morbid obesity, and diabetes.
The relative risk of heart attack for current oral contraceptive users has been estimated to be two to six. Smoking in combination with oral contraceptive use has been shown to contribute substantially to the incidence of myocardial infarctions in women in their mid-thirties or older with smoking accounting for the majority of excess cases.
See Figure 1. Oral contraceptives may compound the effects of well-known risk factors, such as hypertension, diabetes, hyperlipidemias, age and obesity. Similar effects on risk factors have been associated with an increased risk of heart disease. Oral contraceptives must be used with caution in women with cardiovascular disease risk factors.
Thromboembolism An increased risk of thromboembolic and thrombotic disease associated with the use of oral contraceptives is well established. Case control studies have found the relative risk of users compared to nonusers to be 3 for the first episode of superficial venous thrombosis, 4 to 11 for deep vein thrombosis or pulmonary embolism, and 1.
A two- to four-fold increase in relative risk of post-operative thromboembolic complications has been reported with the use of oral contraceptives. Since the immediate postpartum period is also associated with an increased risk of thromboembolism, oral contraceptives should be started no earlier than four weeks after delivery in women who elect not to breastfeed.
Hypertension was found to be a risk factor for both users and nonusers, for both types of strokes, and smoking interacted to increase the risk of stroke. Dose-related risk of vascular disease from oral contraceptives A positive association has been observed between the amount of estrogen and progestogen in oral contraceptives and the risk of vascular disease.
Because estrogens increase HDL cholesterol, the net effect of an oral contraceptive depends on a balance achieved between doses of estrogen and progestogen and the activity of the progestogen used in the contraceptives. The activity and amount of both hormones should be considered in the choice of an oral contraceptive. Minimizing exposure to estrogen and progestogen is in keeping with good principles of therapeutics. New acceptors of oral contraceptive agents should be started on preparations containing the lowest estrogen content which is judged appropriate for the individual patient.
Persistence of risk of vascular disease There are two studies which have shown persistence of risk of vascular disease for ever-users of oral contraceptives. Estimates of Mortality from Contraceptive Use One study gathered data from a variety of sources which have estimated the mortality rate associated with different methods of contraception at different ages Table 2.
These estimates include the combined risk of death associated with contraceptive methods plus the risk attributable to pregnancy in the event of method failure. Each method of contraception has its specific benefits and risks. The study concluded that with the exception of oral contraceptive users 35 and older who smoke, and 40 and older who do not smoke, mortality associated with all methods of birth control is low and below that associated with childbirth. In , the Fertility and Maternal Health Drugs Advisory Committee was asked to review the use of oral contraceptives in women 40 years of age and over.
The Committee concluded that although cardiovascular disease risks may be increased with oral contraceptive use after age 40 in healthy non-smoking women even with the newer low-dose formulations , there are also greater potential health risks associated with pregnancy in older women and with the alternative surgical and medical procedures which may be necessary if such women do not have access to effective and acceptable means of contraception.
Of course, older women, as all women who take oral contraceptives, should take an oral contraceptive which contains the least amount of estrogen and progestogen that is compatible with a low failure rate and individual patient needs.
Carcinoma of the Reproductive Organs and Breasts Numerous epidemiological studies have been performed on the incidence of breast, endometrial, ovarian and cervical cancer in women using oral contraceptives.
The risk of having breast cancer diagnosed may be slightly increased among current and recent users of COCs. However, this excess risk appears to decrease over time after COC discontinuation and by 10 years after cessation the increased risk disappears.
Some studies report an increased risk with duration of use while other studies do not and no consistent relationships have been found with dose or type of steroid. Some studies have found a small increase in risk for women who first use COCs before age Breast cancers diagnosed in current or previous OC users tend to be less clinically advanced than in nonusers.
Women who currently have or have had breast cancer should not use oral contraceptives because breast cancer is usually a hormonally-sensitive tumor. Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia in some populations of women. In spite of many studies of the relationship between oral contraceptive use and breast and cervical cancers, a cause-and-effect relationship has not been established.
Hepatic Neoplasia Benign hepatic adenomas are associated with oral contraceptive use, although the incidence of benign tumors is rare in the United States.
Indirect calculations have estimated the attributable risk to be in the range of 3. However, these cancers are extremely rare in the U. There have been clinical case reports of retinal thrombosis associated with the use of oral contraceptives.
Oral contraceptives should be discontinued if there is unexplained partial or complete loss of vision; onset of proptosis or diplopia; papilledema; or retinal vascular lesions. Appropriate diagnostic and therapeutic measures should be undertaken immediately. Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy.
The administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy. Oral contraceptives should not be used during pregnancy to treat threatened or habitual abortion.
If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period. Oral contraceptive use should be discontinued if pregnancy is confirmed. Earlier studies have reported an increased lifetime relative risk of gallbladder surgery in users of oral contraceptives and estrogens. A small proportion of women will have persistent hypertriglyceridemia while on the pill.
Women with significant hypertension should not be started on hormonal contraception. Women with a history of hypertension or hypertension-related diseases, or renal disease 70 should be encouraged to use another method of contraception. In general, women who develop hypertension during hormonal contraceptive therapy should be switched to a non-hormonal contraceptive. If other contraceptive methods are not suitable, hormonal contraceptive therapy may continue combined with antihypertensive therapy.
The onset or exacerbation of migraine or development of headache with a new pattern which is recurrent, persistent or severe requires discontinuation of oral contraceptives and evaluation of the cause. Breakthrough bleeding and spotting are sometimes encountered in patients on oral contraceptives, especially during the first three months of use. Nonhormonal causes should be considered and adequate diagnostic measures taken to rule out malignancy or pregnancy in the event of breakthrough bleeding, as in the case of any abnormal vaginal bleeding.
If pathology has been excluded, time or a change to another formulation may solve the problem. In the event of amenorrhea, pregnancy should be ruled out. Some women may encounter post-pill amenorrhea or oligomenorrhea, especially when such a condition was preexistent. It is good medical practice for all women to have annual history and physical examinations, including women using oral contraceptives. The physical examination, however, may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician.
The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology, and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care. Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives.
If jaundice develops in any woman receiving such drugs, the medication should be discontinued. Steroid hormones may be poorly metabolized in patients with impaired liver function.
Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention. Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree.
Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
POPs mainly just change the viscosity of mucus and thin the endometrium; however, in some women, they may also prevent ovulation, although this is usually inconsistent. Oral contraceptives will work only as long as they are taken regularly. Tell your doctor if any of these symptoms are severe or do not go away: nausea vomiting stomach cramps or bloating diarrhea constipation gingivitis swelling of the gum tissue increased or decreased appetite weight gain or weight loss brown or black skin patches acne hair growth in unusual places bleeding or spotting between menstrual periods changes in menstrual flow painful or missed periods breast tenderness, enlargement, or discharge swelling, redness, irritation, burning, or itching of the vagina white vaginal discharge Some side effects can be serious. Bradsberry M. Current Congress.
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METHODS: Relative risk estimates from the WHO Collaborative Study and observed incidence rates from the Oxford region were used to estimate age specific incidence of each disease among women without cardiovascular risk factors and model total cardiovascular incidence and mortality. Cardiovascular mortality associated with smoking was greater than that associated with OC use at all ages.
Attributable risk associated with OC use was 1 death per , users annually among women aged years, 1 per , at ages years, and 1 per 37, at ages years. Among smokers, the cardiovascular mortality attributable to OC use was estimated to be about 1 per , users annually among women aged less than 35 years, and about 1 per 10, users annually among those above the age of 35 years.
The potentially avoidable excess VTE risk associated with the newer progestogens desogestrel and gestodene would account for a substantial proportion of total cardiovascular morbidity in this age group. For women over age 35 years the absolute risks associated with OC use and smoking are greater because of the steeply rising incidence of arterial diseases. The combination of smoking and OC use among such women is associated with particularly increased risks. However, the mortality associated with smoking is far greater than that associated with OC use of any type at all ages.
National Center for Biotechnology Information , U. J Epidemiol Community Health. Farley , O. Meirik , C. Chang , and N. Copyright and License information Disclaimer. Copyright notice. This article has been cited by other articles in PMC. Reliability of data from proxy respondents in an international case-control study of cardiovascular disease and oral contraceptives.
Registration procedures, event rates, and case-fatality rates in 38 populations from 21 countries in four continents. Oral contraceptives and cardiovascular disease first of two parts. N Engl J Med. Myocardial infarction in users of low-dose oral contraceptives.
Obstet Gynecol. Stroke in users of low-dose oral contraceptives. Incidence of stroke and myocardial infarction in women of reproductive age. Population-based study of risk of venous thromboembolism associated with various oral contraceptives. Fatal stroke and use of oral contraceptives: findings from a case-control study. Am J Epidemiol. Event, incidence and case fatality rates of cerebrovascular disease in Auckland, New Zealand.
Use of low-dose oral contraceptives and stroke in young women. Ann Intern Med. Third generation oral contraceptives and risk of venous thromboembolic disorders: an international case-control study. Using admission characteristics to predict short-term mortality from myocardial infarction in elderly patients.
Comparison of case fatality in smokers and non-smokers after acute cardiac event. Hormonal contraception and risk of cardiovascular disease. An international perspective. Increased risk of venous thrombosis in oral-contraceptive users who are carriers of factor V Leiden mutation. World distribution of factor V Leiden. Ethnic distribution of factor V Leiden in men and women. Implications for venous thromboembolism screening.
Factor V Leiden and third-generation oral contraceptives. Oral contraceptives and venous thrombosis: different sensitivities to activated protein C in women using second- and third-generation oral contraceptives.