What are the contraindications for Alesse (levonorgestrel and ethinyl estradiol)?

From the Guidelines

Alesse (levonorgestrel and ethinyl estradiol) is contraindicated in patients with antiphospholipid antibody–positive status due to the increased risk of thrombosis. This is based on the recommendation from the 2020 American College of Rheumatology guideline for the management of reproductive health in rheumatic and musculoskeletal diseases 1. The guideline strongly recommends against combined estrogen-progestin contraceptives, such as Alesse, in women with positive antiphospholipid antibodies (aPL) because estrogen increases the risk of thromboembolism.

Some key points to consider regarding Alesse contraindications include:

• The risk of venous thromboembolism (VTE) in healthy women taking combined estrogen-progestin contraceptives is significantly higher than the baseline annual risk 1.
• Progestin-only methods are widely accepted as a lower-risk option in patients for whom estrogens are contraindicated but who still need effective contraception 1.
• The specific progestin and its serum level affect thrombosis risk, with varying odds ratios for VTE risk depending on the progestin type 1.
• The copper IUD is a highly effective alternative that does not increase the risk of VTE, but it may increase menstrual bleeding and cramping for several months after insertion 1.

In the context of Alesse, it is crucial to avoid its use in patients with conditions that may increase the risk of thrombosis, such as antiphospholipid antibody syndrome. This is to minimize the risk of adverse health outcomes, including morbidity, mortality, and decreased quality of life. The recommendation against Alesse in these patients is based on the most recent and highest-quality evidence available 1.

From the FDA Drug Label

When not to use levonorgestrel tablet Levonorgestrel tablet should not be used: as a regular birth control method, because it's not as effective as regular birth control. if you are already pregnant, because it will not work. if you are allergic to levonorgestrel or any other ingredients in levonorgestrel tablet. Warnings Allergy alert Do not use if you have ever had an allergic reaction to levonorgestrel Sexually transmitted diseases (STDs) alert This product does not protect against HIV/AIDS or other STDs. Do not use if you are already pregnant (because it will not work) for regular birth control

The contraindications for Alesse (levonorgestrel and ethinyl estradiol) are:

• Allergy: if you are allergic to levonorgestrel or any other ingredients in the tablet
• Pregnancy: if you are already pregnant, because it will not work
• Regular birth control: as a regular birth control method, because it's not as effective as regular birth control
• HIV/AIDS or other STDs: this product does not protect against HIV/AIDS or other STDs 2 2

From the Research

Alesse Contraindications

Alesse, a combination oral contraceptive containing levonorgestrel and ethinyl estradiol, has several contraindications to consider:

• Venous thromboembolism (VTE): The use of Alesse may increase the risk of VTE, particularly in women with a history of VTE or thrombophilia 3, 4, 5.
• Thrombophilia: Women with a history of thrombophilia or close relatives suffering from VTE in younger than 50 years should be screened for thrombophilia before using Alesse 3.
• Liver disease: Although rare, levonorgestrel-releasing intrauterine devices have been associated with acute liver injury, and caution should be exercised in women with liver disease 6.
• Breast cancer: The use of Alesse may not be recommended for women with breast cancer, as tamoxifen therapy may increase the risk of endometrial hyperplasia, polyps, and endometrial cancer, and the levonorgestrel-releasing intrauterine system may be a preferred option for endometrial protection 7.
• Pregnancy: Alesse is contraindicated in pregnant women, as it may cause harm to the fetus.
• Undiagnosed abnormal vaginal bleeding: Alesse is contraindicated in women with undiagnosed abnormal vaginal bleeding, as it may mask the underlying condition.

Special Considerations

When prescribing Alesse, healthcare providers should consider the following:

• Women with a history of VTE or thrombophilia should be counseled on the increased risk of VTE associated with Alesse use 3, 4, 5.
• Women with liver disease should be monitored for signs of liver injury while using Alesse 6.
• Women with breast cancer should be considered for alternative contraceptive methods, such as the levonorgestrel-releasing intrauterine system, for endometrial protection 7.