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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 doses of estrogens and progestogens than those in common use today. Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Lybrel (levonorgestrel and ethinyl estradol tablets) is a non-cyclic oral contraceptive that provides a low daily dose of estrogen and progestin; however, Lybrel (levonorgestrel and ethinyl estradol tablets) provides women with more hormonal exposure on a yearly basis (13 additional weeks of hormone intake per year) than conventional cyclic oral contraceptives containing the same strength of synthetic estrogens and similar strength of progestins. Smoking in combination with oral contraceptive use has been shown to contribute substantially to the incidence of myocardial infarction in women in their mid-thirties or older with smoking accounting for the majority of excess cases.
An increased risk of venous thromboembolic and thrombotic disease associated with the use of oral contraceptives is well established. A two-to-four fold increase in relative risk of postoperative thromboembolic complications has been reported with the use of oral contraceptives.
Oral contraceptives have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest among older (>35 years), hypertensive women who also smoke.
A positive association has been observed between the amount of estrogen and progestogen in oral contraceptives and the risk of vascular disease.
Minimizing exposure to estrogen and progestogen is in keeping with good principles of therapeutics.
There are two studies which have shown persistence of risk of vascular disease for ever-users of oral contraceptives. In another study in Great Britain, the risk of developing cerebrovascular disease persisted for at least 6 years after discontinuation of oral contraceptives, although excess risk was very small. 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 3).
Because of these changes in practice, and also because of some limited new data which suggest that the risk of cardiovascular disease with the use of oral contraceptives may now be less than previously observed, the Fertility and Maternal Health Drugs Advisory Committee was asked to review the topic in 1989. Therefore, the Committee recommended that the benefits of oral contraceptive use by healthy nonsmoking women over 40 may outweigh the possible risks. Numerous epidemiological studies have examined the association between the use of oral contraceptives and the incidence of breast and cervical cancer. The risk of having breast cancer diagnosed may be slightly increased among current and recent users of combination oral contraceptives. Breast cancers diagnosed in current or previous oral contraceptive users tend to be less clinically advanced than in nonusers. Women with known or suspected carcinoma of the breast or personal history of 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 or invasive cervical cancer in some populations of women. In spite of many studies of the relationship between combination oral contraceptive use and breast and cervical cancers, a cause-and-effect relationship has not been established. Endometrial biopsies performed in a subset of subjects (Study 1; n = 93) ages 18 to 49 years, after 6 to 12 months of use of Lybrel (levonorgestrel and ethinyl estradol tablets) , did not reveal any hyperplasias or malignancies.
Benign hepatic adenomas are associated with oral contraceptive use, although the incidence of these benign tumors is rare in the United States. Studies from Britain have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) oral contraceptive user. There have been clinical case reports of retinal thrombosis associated with the use of oral contraceptives that may lead to partial or complete loss of vision. The administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy. The possibility of pregnancy should be considered in any patient who may be experiencing symptoms of pregnancy, especially if she has not adhered to the prescribed schedule. Combination oral contraceptives may worsen existing gallbladder disease and may accelerate the development of this disease in previously asymptomatic women. Oral contraceptives have been shown to cause glucose intolerance in a significant percentage of users. An increase in blood pressure has been reported in women taking oral contraceptives and this increase is more likely in older oral contraceptive users and with continued use.
Figure 4 shows the percentage of Lybrel (levonorgestrel and ethinyl estradol tablets) subjects in study 313-NA by pill-pack who experienced unscheduled bleeding or spotting only (Defined as "No sanitary protection required"). As in any case of bleeding irregularities, nonhormonal causes should be considered and adequate diagnostic measures may be indicated to rule out pregnancy, infection, malignancy, or other conditions.
Some women may encounter post-pill amenorrhea or oligomenorrhea (possibly with anovulation), especially when such a condition was preexistent.
Scheduled withdrawal bleeding does not occur with the use of Lybrel (levonorgestrel and ethinyl estradol tablets) , therefore, the absence of withdrawal bleeding cannot be used as a sign of an unexpected pregnancy and as such, unexpected pregnancy may be difficult to recognize.


A periodic personal and family medical history and complete physical examination are appropriate for all women, including women using oral contraceptives. A small proportion of women will have adverse lipid changes while taking oral contraceptives.
If jaundice develops in any woman receiving such drugs, the medication should be discontinued. Patients becoming significantly depressed while taking oral contraceptives should stop the medication and use an alternate method of contraception in an attempt to determine whether the symptom is drug related. Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist. Safety and efficacy of Lybrel (levonorgestrel and ethinyl estradol tablets) tablets have been established in women of reproductive age. This product has not been studied in women over 65 years of age and is not indicated in this population.
Food and Drug Administration on Wednesday approved a request by Danco Laboratories to expand authorized use of its abortion pill Mifeprex (mifepristone), formerly known as RU-486, to 70 days of gestation from 49 days.
The effect of long-term use of the oral contraceptives with lower doses of both estrogens and progestogens remains to be determined. Case control studies provide a measure of the relative risk of disease, namely, a ratio of the incidence of a disease among oral contraceptive users to that among nonusers. 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.
Mortality rates associated with circulatory disease have been shown to increase substantially in smokers over the age of 35 and nonsmokers over the age of 40 (Figure 3) among women who use oral contraceptives.
The risk of venous thrombotic and thromboembolic events is further increased in women with conditions predisposing for venous thrombosis and thromboembolism. The relative risk of venous thrombosis in women who have predisposing conditions is twice that of women without such medical conditions. Hypertension was found to be a risk factor for both users and nonusers, for both types of strokes, while smoking interacted to increase the risk for hemorrhagic strokes. A decline in serum high-density lipoproteins (HDL) has been reported with many progestational agents. In a study in the United States, the risk of developing myocardial infarction after discontinuing oral contraceptives persisted for at least 9 years for women 40-49 years who had used oral contraceptives for five or more years, but this increased risk was not demonstrated in other age groups. However, both studies were performed with oral contraceptive formulations containing 0.05 mg or higher of estrogens. These estimates include the combined risk of death associated with contraceptive methods plus the risk attributable to pregnancy in the event of method failure. The Committee concluded that although cardiovascular disease risks may be increased with oral contraceptive use after age 40 in healthy nonsmoking women (even with the newer low-dose formulations), there are 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 the lowest possible dose formulation that is effective. However, this excess risk appears to decrease over time after combination oral contraceptive discontinuation and by 10 years after cessation the increased risk disappears. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors. Endometrial malignancy is rare in this age group, so change in the risk is unlikely to be detected with a study of this size. Oral contraceptives should not be used during pregnancy to treat threatened or habitual abortion.
Earlier studies have reported an increased lifetime relative risk of gallbladder surgery in users of oral contraceptives and estrogens.
Oral contraceptives containing greater than 0.075 mg of estrogens cause hyperinsulinism, while lower doses of estrogen cause less glucose intolerance. Data from the Royal College of General Practitioners and subsequent randomized trials have shown that the incidence of hypertension increases with increasing quantities of progestogens. Although pregnancy is unlikely if Lybrel (levonorgestrel and ethinyl estradol tablets) is taken as directed, if for any reason pregnancy is suspected in a woman using Lybrel (levonorgestrel and ethinyl estradol tablets) , a pregnancy test should be performed. The physical examination, however, may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician. 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. In addition, combination oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older.


The relative risk does not provide information on the actual clinical occurrence of a disease. The relative risk of heart attack for current oral contraceptive users has been estimated to be two to six. Case control studies have found the relative risk of users compared to non-users to be 3 for the first episode of superficial venous thrombosis, 4 to 11 for deep-vein thrombosis or pulmonary embolism, and 1.5 to 6 for women with predisposing conditions for venous thromboembolic disease. If feasible, oral contraceptives should be discontinued at least four weeks prior to and for two weeks after elective surgery of a type associated with an increase in risk of thromboembolism and during and following prolonged immobilization.
A decline in serum high-density lipoproteins has been associated with an increased incidence of ischemic heart disease. New acceptors of oral contraceptive agents should be started on preparations containing the lowest estrogen content which is judged appropriate for the individual patient.
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. Rupture of rare, benign, hepatic adenomas may cause death through intra-abdominal hemorrhage. More recent studies, however, have shown that the relative risk of developing gallbladder disease among oral contraceptive users may be minimal.
Progestogens increase insulin secretion and create insulin resistance, this effect varying with different progestational agents. During the final cycle of use of Lybrel (levonorgestrel and ethinyl estradol tablets) (Pill Pack 13), these percentages were 31% and 20%, respectively. The physical examination should include special reference to blood pressure, breasts, abdomen, and pelvic organs, including cervical cytology, and relevant laboratory tests. Persistent hypertriglyceridemia may occur in a small population of combination oral contraceptive users. If possible, the nursing mother should be advised not to use combination oral contraceptives but to use other forms of contraception until she has completely weaned her child. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral contraceptive users and nonusers. Cohort studies have shown the relative risk to be somewhat lower, about 3 for new cases and about 4.5 for new cases requiring hospitalization.
Because the immediate post-partum 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 breast-feed, or after a midtrimester pregnancy termination.
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 nature and absolute amount of progestogen used in the contraceptive. 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 less than that associated with childbirth. Some studies have reported a small increase in risk for women who first use combination oral contraceptives at a younger age. The recent findings of minimal risk may be related to the use of oral contraceptive formulations containing lower hormonal doses of estrogens and progestogens.
However, in the nondiabetic woman, oral contraceptives appear to have no effect on fasting blood glucose. In case of undiagnosed, persistent, or recurrent abnormal vaginal bleeding, appropriate diagnostic measures should be conducted to rule out malignancy. The attributable risk does provide information about the actual occurrence of a disease in the population. The observation of a possible increase in risk of mortality with age for oral contraceptive users is based on data gathered in the 1970's - but not reported until 1983. Most studies show a similar pattern of risk with combination oral contraceptive use regardless of a woman's reproductive history or her family breast cancer history. Because of these demonstrated effects, prediabetic and diabetic women should be carefully observed while taking oral contraceptives. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care. However, the incidence is less than that associated with pregnancy (6 per 10,000 woman-years).
However, current clinical practice involves the use of lower estrogen dose formulations combined with careful restriction of oral contraceptive use to women who do not have the various risk factors listed in this labeling. The excess risk is highest during the first year a woman ever uses a combined oral contraceptive. The risk of thromboembolic disease due to oral contraceptives is not related to length of use and gradually disappears after pill use is stopped.



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