Combined Oral Contraceptives in Patients with Factor V Leiden Mutation
Women with Factor V Leiden mutation should generally avoid combined oral contraceptive pills due to the significantly increased risk of venous thromboembolism, with alternative contraceptive methods being preferred.
Risk Assessment
- Combined oral contraceptives (COCs) produce a 30-fold increase in thrombotic risk when the Factor V Leiden mutation is also present, compared to a 4-fold increase with COCs alone 1
- The absolute risk remains relatively low in young women, with an estimated 15 deaths per million woman-years in Factor V Leiden carriers using COCs (compared to 4 deaths per million woman-years with COCs alone) 1
- Factor V Leiden is considered a "known thrombogenic mutation" and is listed as an absolute contraindication (Category 4) to COC use in current contraceptive guidelines 1
Recommendations Based on Clinical Scenario
Women with Known Factor V Leiden Mutation:
- COCs should be avoided in women with known Factor V Leiden mutation 1, 2
- The risk is particularly high for:
Alternative Contraceptive Options:
- Non-hormonal methods are preferred (copper IUD) 2, 3
- Progestin-only methods may be considered, though some case reports suggest caution even with these options 3
- The risk of pregnancy complications (including VTE) should be weighed against contraceptive risks 1
Special Considerations
The American College of Medical Genetics recommends:
- Factor V Leiden testing for women with VTE during pregnancy or oral contraceptive use 1
- Against routine screening for Factor V Leiden in asymptomatic women contemplating or using oral contraceptives 1
- Consideration of testing in women with a family history of thromboembolism, activated protein C resistance, or documented Factor V Leiden mutation 1
Women with a personal history of VTE should avoid COCs regardless of Factor V Leiden status 1, 2
Clinical Perspective
- While the relative risk increase is substantial (5.89-fold for "mild" thrombophilias like Factor V Leiden) 4, the absolute risk must be considered in context
- Some studies suggest the risk may be lower than initially reported - potentially 10-15 fold increased risk rather than >30-fold 5
- Universal screening for Factor V Leiden before COC prescription is not recommended due to cost-effectiveness concerns and potential negative impacts on contraceptive access 6
Bottom Line
For patients with known Factor V Leiden mutation, the safest approach is to avoid combined oral contraceptives and use alternative contraceptive methods. The risk is particularly significant for those with additional risk factors or homozygous mutation status.