What are the benefits and potential side effects of combined oral contraceptives, such as Alesse (levonorgestrel and ethinyl estradiol), and how can patients minimize risks?

Benefits and Side Effects of Combined Oral Contraceptives

Combined oral contraceptives (COCs) are highly effective contraceptives with a typical-use failure rate of 9%, but they also carry risks including increased risk of venous thromboembolism that must be weighed against their benefits.

Benefits of Combined Oral Contraceptives

Contraceptive Benefits

• Highly effective when used correctly (perfect-use failure rate of 0.3%) 1
• Reversible with no negative effect on long-term fertility 1
• Convenient daily oral administration

Non-Contraceptive Health Benefits

• Increased menstrual cycle regularity
• Decreased menstrual blood loss and decreased incidence of iron deficiency anemia
• Decreased incidence of dysmenorrhea (painful periods)
• Decreased incidence of functional ovarian cysts
• Decreased incidence of ectopic pregnancies
• Long-term benefits include:
  • Decreased incidence of fibroadenomas and fibrocystic breast disease
  • Decreased incidence of acute pelvic inflammatory disease
  • Decreased incidence of endometrial cancer
  • Decreased incidence of ovarian cancer 2
• Can improve acne by reducing free testosterone levels 1

Potential Side Effects and Risks

Common Side Effects

• Irregular bleeding, especially in first few cycles
• Headache
• Nausea
• Breast tenderness 1

Serious Risks

• Venous thromboembolism (VTE): Increases risk from 1 per 10,000 to 3-4 per 10,000 woman-years 1
  • Risk is still lower than during pregnancy (10-20 per 10,000 woman-years) 1
  • Risk increases with higher estrogen doses 1
  • Risk varies by progestin type 3
• Increased blood pressure in some women 2
• Slight increased risk of cervical cancer with long-term use 2
• Rare risk of benign liver tumors (hepatic adenomas) 2

Contraindications

COCs should not be prescribed for patients with:

• Severe and uncontrolled hypertension (systolic ≥160 mm Hg or diastolic ≥100 mm Hg)
• Ongoing hepatic dysfunction
• Complicated valvular heart disease
• Migraines with aura or focal neurologic symptoms
• Thromboembolism or thrombophilia
• Complications of diabetes (nephropathy, retinopathy, neuropathy)
• Complicated solid organ transplantation 1
• Current breast cancer 3

Minimizing Risks

Appropriate Selection

• Choose COCs with the lowest effective dose of estrogen (≤35 μg ethinyl estradiol) 1, 4
• First-line options for most women include pills containing levonorgestrel or norethisterone with ≤35 μg ethinyl estradiol 4
• Consider patient risk factors before prescribing:
  • Smoking increases risk of cardiovascular events, especially in women >35 years 2
  • History of hypertension, diabetes, or hyperlipidemia increases cardiovascular risk 2

Proper Use Instructions

• Take pills at the same time each day
• Use backup contraception (condoms or abstinence) for at least the first 7 days after starting COCs 1
• If a pill is missed:
  • Take the missed pill as soon as remembered
  • If more than one pill is missed, take only the most recently missed pill
  • Use backup contraception until 7 consecutive hormone pills have been taken 1
• Consider using adherence strategies like cell phone alarms or support from family/partner 1

Regular Monitoring

• Follow-up visit 1-3 months after starting COCs to address adverse effects or adherence issues 1
• Monitor blood pressure regularly
• Be alert for warning signs of serious complications:
  • Severe headache
  • Visual changes
  • Chest pain or shortness of breath
  • Severe leg pain or swelling 2

Special Considerations

Drug Interactions

• Some medications can decrease COC effectiveness:
  • Certain antibiotics (rifampin)
  • Some anticonvulsants
  • Some antiretroviral medications 1
• When taking these medications, additional contraceptive methods should be used

Switching Between Formulations

• If side effects occur, changing the amount of estrogen or type of progestin may help 1
• Breakthrough bleeding is one of the most common reasons for discontinuation 5
• Extended-cycle regimens (with fewer or no hormone-free intervals) are available and may be preferred by some women 6, 4

Important Counseling Points

• Explain that common side effects like irregular bleeding, headache, and nausea are often transient and improve after the first few cycles 1
• Emphasize that COCs do not protect against sexually transmitted infections; condoms should be used for STI protection 1
• Discuss the importance of not smoking while using COCs, especially for women over 35 2
• Inform patients that fertility returns quickly after discontinuation 1

By understanding both the benefits and potential risks of combined oral contraceptives, patients can make informed decisions about their contraceptive choices and take steps to minimize risks while maximizing benefits.