Can patients with a history of Deep Vein Thrombosis (DVT) take Raloxifene (Evista)?

Raloxifene Should Not Be Used in Patients with a History of DVT

Raloxifene is contraindicated in patients with a history of deep vein thrombosis (DVT) and should not be prescribed to these patients due to significantly increased risk of recurrent venous thromboembolism. 1, 2

Contraindications for Raloxifene

The American Society of Clinical Oncology (ASCO) clinical practice guidelines clearly state that raloxifene is not recommended for use in women with:

• History of deep vein thrombosis
• Pulmonary embolism
• Stroke or transient ischemic attack
• During prolonged immobilization 1

This contraindication is also explicitly stated in the FDA drug label for raloxifene, which indicates that the medication is contraindicated in women with active or past history of venous thromboembolism (VTE), including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis 2.

Evidence for Increased Thrombotic Risk

The risk of thromboembolic events with raloxifene is well-documented:

• Meta-analysis of nine trials involving 24,523 postmenopausal women found raloxifene was associated with a 54% increase in odds of DVT (odds ratio = 1.54; 95% CI = 1.13 to 2.11) and a 91% increase in odds of pulmonary embolism (odds ratio = 1.91; 95% CI = 1.05 to 3.47) 3

• In the Multiple Outcomes of Raloxifene Evaluation (MORE) trial, raloxifene increased the risk of venous thromboembolic disease with a relative risk of 3.1 (95% CI, 1.5-6.2) 4, 5

• The Journal of the National Comprehensive Cancer Network (JNCCN) guidelines emphasize that women with documented thromboembolic disease should undergo appropriate treatment for the thromboembolic condition and should permanently discontinue raloxifene therapy 1

Alternative Options for Breast Cancer Risk Reduction

For patients who need breast cancer risk reduction but have a history of DVT, alternative medications should be considered:

• Exemestane (25 mg/day orally for 5 years) can be discussed as an alternative to raloxifene for reducing the risk of invasive breast cancer in postmenopausal women at increased risk 1

• Anastrozole (1 mg/day orally for 5 years) is another alternative for postmenopausal women at increased risk of developing breast cancer 1

Alternative Options for Osteoporosis

For patients who need osteoporosis treatment but have a history of DVT:

• Oral or IV bisphosphonates are recommended over raloxifene 1
• Denosumab or PTH/PTHrP analogs can be considered 1

Clinical Approach

When evaluating a patient with a history of DVT who might otherwise be a candidate for raloxifene:

1. Absolutely avoid raloxifene due to contraindication
2. For breast cancer risk reduction: Consider aromatase inhibitors (exemestane or anastrozole) if postmenopausal
3. For osteoporosis: Consider bisphosphonates, denosumab, or PTH/PTHrP analogs

Common Pitfalls to Avoid

• Prescribing raloxifene despite history of DVT based solely on its benefits for breast cancer risk reduction or osteoporosis
• Failing to recognize that the contraindication applies to any history of DVT, not just recent or active DVT
• Not considering the significantly increased risk of recurrent venous thromboembolism (3-fold higher risk)
• Overlooking alternative medications that do not carry the same thrombotic risk

The evidence is clear and consistent across multiple high-quality guidelines that raloxifene should not be used in patients with a history of DVT due to the significantly increased risk of recurrent thrombotic events.