Junel Fe 1/20

Thromboembolic Disorders and Other Vascular Problems

• Myocardial infarction (MI): 

• Increased risk for MI especially in smokers or women with other underlying risk factors for coronary artery disease (eg, hypertension, hypercholesterolemia, morbid obesity, diabetes). A substantial increase in mortality rates associated with circulatory disease has been shown in smokers over the age of 35 and non-smokers over the age of 40.

• Oral contraceptives may worsen the effects of well-known risk factors (eg, hypertension, diabetes, hyperlipidemias, age and obesity).

• Use caution in women with cardiovascular disease risk factors.

• Thromboembolism:

• Increased risk for thromboembolic and thrombotic disease.

• The risk for thromboembolic disease is not related to the length of use and disappears after discontinuing oral contraceptives.

• If possible, discontinue at least 4 weeks before and for 2 weeks after elective surgery associated with an increased risk for thromboembolism, and during and following prolonged immobilization.

• Do not initiate oral contraceptives earlier than 4–6 weeks after delivery in women who choose not to breastfeed.

• Cerebrovascular disease:

• Increased risk for cerebrovascular disease (thrombotic and hemorrhagic strokes), especially in hypertensive women >35yrs who also smoke.

• Dose-related risk of vascular disease from oral contraceptives:

• Minimize exposure to estrogen and progestogen.

• Prescribe a dosage regimen that contains the least amount of estrogen and progestogen that is compatible with the needs of the patient. 

• Persistence of risk of vascular disease:

• Two studies have shown the persistence of risk for vascular disease for ever-users of oral contraceptives.

Estimates of Mortality from Contraceptive Use

• The benefits of oral contraceptive use by healthy non-smoking women over 40 may outweigh the possible risks. Older women, as all women who take oral contraceptives should take the lowest possible dose formulation that is effective.

Carcinoma of the Reproductive Organs

• Numerous epidemiological studies have been performed on the incidence of breast, endometrial, ovarian, and cervical cancer in women using oral contraceptives. 

• The relationship between oral contraceptive use and breast and cervical cancers, a cause and effect relationship has not been established.

Hepatic Neoplasia

• Oral contraceptive use is associated with benign hepatic adenomas. A rupture of these rare, benign hepatic adenomas may lead to death via intra-abdominal hemorrhage.

• Although extremely rare, there are also studies from Britain that have shown an increased risk for developing hepatocellular carcinoma among long-term oral contraceptive users (>8yrs).

Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment

• Discontinue prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

• May restart Junel approximately 2 weeks after completing treatment with the combination drug regimen.

Ocular Lesions

• Retinal thrombosis has been reported. Discontinue oral contraceptives if unexplained partial or complete loss of vision; onset of proptosis or diplopia; papilledema; or retinal vascular lesions occurs.

Oral Contraceptive Use Before and During Early Pregnancy

• Do not use during pregnancy.

• It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out before continuing oral contraceptive use. Discontinue oral contraceptive use if pregnancy is confirmed.

Gallbladder Disease

• Recent studies have shown that the risk for developing gallbladder disease in oral contraceptive users may be minimal.

Carbohydrate And Lipid Metabolic Effects

• May cause glucose intolerance; oral contraceptives containing >75 mcg of estrogens cause hyperinsulinism.

• Monitor carefully in prediabetic and diabetic women.

Elevated Blood Pressure

• An alternative method of contraception is recommended in women with a history of hypertension or hypertension-related diseases or renal disease. If women choose to use oral contraceptives, then monitor closely; discontinue use if significant elevation of blood pressure occurs.

Headache

• Discontinue if onset or exacerbation of migraine or development of headache with a new pattern which is recurrent, persistent, or severe occurs.

Bleeding Irregularities

• If breakthrough bleeding and spotting occurs esp. during the first 3 months of use, consider nonhormonal causes, and adequate diagnostic measures taken to rule out malignancy or pregnancy.

Physical Examination and Follow-Up

• All women should obtain a physical examination which includes special reference to blood pressure, breasts, abdomen and pelvic organs (eg, cervical cytology), and relevant laboratory tests.

• Monitor with particular care in women with a strong family history of breast cancer or who have breast nodules.

Lipid Disorders

• Closely monitor women who are being treated for hyperlipidemia.

Liver Function

• Discontinue oral contraceptives if jaundice develops.

Fluid Retention

• Exercise caution and monitor carefully in patients with conditions which might worsen by fluid retention.

Emotional Disorders

• Monitor carefully in women with a history of depression. Discontinue if depression recurs to a serious degree.

Contact Lenses

• An ophthalmologist should assess contact lens wearers who develop visual changes or changes in lens tolerance.