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Contraindications and Warnings

Contraindications1

Combination oral contraceptives (COCs) such as LYBREL® should not be used in women with any of the following conditions:

  • Thrombophlebitis or thromboembolic disorders
  • History of deep-vein thrombophlebitis or thromboembolic disorders
  • Cerebrovascular or coronary artery disease (current or past history)
  • Valvular heart disease with complications
  • Thrombogenic rhythm disorders
  • Hereditary or acquired thrombophilias
  • Major surgery with prolonged immobilization
  • Diabetes with vascular involvement
  • Headaches with focal neurological symptoms such as aura
  • Uncontrolled hypertension
  • Known or suspected carcinoma of the breast or personal history of breast cancer
  • Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
  • Undiagnosed abnormal genital bleeding
  • Cholestatic jaundice of pregnancy or jaundice with prior pill use
  • Hepatic adenomas or carcinomas, or active liver disease
  • Known or suspected pregnancy
  • Hypersensitivity to any of the components of LYBREL

Warnings1

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes per day was associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

The use of oral contraceptives is associated with increased risks of several serious conditions including venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, stroke, and transient ischemic attack), hepatic neoplasia, gallbladder disease, and hypertension, 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 certain inherited or acquired thrombophilias, hypertension, hyperlipidemias, obesity, diabetes, and surgery or trauma with increased risk of thrombosis.

Please see the full Prescribing Information for the complete warning information.

Next: Prescribing LYBREL »

Important Safety Information

  • Oral contraceptives (OCs) do not protect against HIV infection or other sexually transmitted diseases.
  • When prescribing LYBREL, the convenience of having no scheduled menstrual bleeding should be weighed against the inconvenience of unscheduled breakthrough bleeding and spotting.
  • OCs are contraindicated in women who have blood clots; breast, uterine, or liver cancers; a history of heart attack, stroke, or breast cancer; as well as those who are or may be pregnant.
The risks of serious cardiovascular side effects are substantially increased in women who smoke and use OCs, especially in women over age 35. Women who use oral contraceptives should be strongly advised not to smoke.
  • Serious risks associated with OCs include blood clots, heart attack, and stroke.
  • LYBREL 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.
  • Scheduled withdrawal bleeding does not occur with the use of LYBREL, 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. Although pregnancy is unlikely if LYBREL is taken as directed, if for any reason, pregnancy is suspected in a woman using LYBREL, a pregnancy test should be performed.
  • The most commonly reported treatment emergent adverse events reported with LYBREL in a clinical trial were headache, dysmenorrhea, upper respiratory infection, vaginal bleeding (defined as metrorrhagia and vaginal hemorrhage), and nausea.

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