Should Tamoxifen (tamoxifen citrate) be discontinued in patients with acute stroke?

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From the Guidelines

Yes, Tamoxifen (tamoxifen citrate) should be discontinued in patients with acute stroke.

Rationale

  • The use of tamoxifen is associated with an increased risk of ischemic stroke, particularly in women aged 50 years or older 1.
  • Tamoxifen is contraindicated in women with a prior history of stroke or transient ischemic attack 1.
  • The American Society of Clinical Oncology clinical practice guideline recommends that tamoxifen should not be used in women with a history of deep vein thrombosis, pulmonary embolus, stroke, or transient ischemic attack 1.
  • Discontinuation of tamoxifen is recommended in patients with documented thromboembolic disease, including stroke 1.
  • The risk of stroke is significantly elevated in women taking tamoxifen, with a relative risk of 1.42 (95% CI, 0.97 to 2.08) compared to placebo 1.

From the FDA Drug Label

For all women in this study, taking tamoxifen citrate tablets increased the risk of having a blood clot in their lungs or veins, or of having a stroke. Stroke can cause serious medical problems, including death If you get any signs of stroke, call your doctor right away. The signs of stroke are: sudden weakness, tingling, or numbness in your face, arm or leg, especially on one side of your body sudden confusion, trouble speaking or understanding sudden trouble seeing in one or both eyes sudden trouble walking, dizziness, loss of balance or coordination sudden severe headache with no known cause

The FDA drug label does not provide guidance on whether tamoxifen should be discontinued in patients with acute stroke. However, given the increased risk of stroke associated with tamoxifen, it is reasonable to consider discontinuing the medication in the event of an acute stroke, as a precautionary measure to prevent further risk. 2

From the Research

Tamoxifen Discontinuation in Patients with Acute Stroke

  • The decision to discontinue tamoxifen in patients with acute stroke should be based on individual patient factors and the potential risks and benefits of continuing therapy 3, 4.
  • Studies have shown that tamoxifen may be associated with an increased risk of stroke, particularly cerebral venous thrombosis 5.
  • However, other studies have found no significant association between tamoxifen use and stroke risk 3.
  • Factors that may influence the decision to discontinue tamoxifen include the patient's overall health status, the presence of other stroke risk factors, and the potential benefits of continuing tamoxifen therapy for breast cancer treatment or prevention.

Considerations for Discontinuation

  • Patients who experience a stroke while taking tamoxifen may need to be evaluated on a case-by-case basis to determine whether discontinuation of therapy is necessary 4, 5.
  • The presence of other stroke risk factors, such as hypertension, diabetes, or a history of thromboembolic events, may also influence the decision to discontinue tamoxifen 3, 6.
  • Additionally, the patient's breast cancer status and the potential benefits of continuing tamoxifen therapy should be taken into account when making decisions about discontinuation 7, 6.

Evidence for Discontinuation

  • A study published in the International Journal of Surgery Case Reports found that a patient who experienced cerebral venous thrombosis while taking tamoxifen had abnormal laboratory findings consistent with coagulopathy, which resolved after discontinuation of therapy 5.
  • Another study published in the Journal of Clinical Oncology found that older women with estrogen receptor-positive breast cancer who discontinued tamoxifen therapy were more likely to have certain comorbidities, such as cardiopulmonary disease, and to have received breast-conserving surgery without radiotherapy 6.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Stroke risk and tamoxifen therapy for breast cancer.

Journal of the National Cancer Institute, 2004

Research

The cerebrovascular risks associated with tamoxifen use.

Expert opinion on drug safety, 2005

Research

Predictors of tamoxifen discontinuation among older women with estrogen receptor-positive breast cancer.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2008

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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