Drug Notebook

FDA Alerts

  • For women with ductal carcinoma in situ (DCIS) and women at high risk for breast cancer: serious and life-threatening events associated with tamoxifen in the risk reduction setting include uterine malignancies, stroke, and pulmonary embolism. Incidence rates for these events have been estimated from the NSABP P-1 trial (median length of follow-up 6.9 years).

    Uterine malignancies consist of both endometrial adenocarcinoma (incidence rate per 1000 women-years of 2.2 for tamoxifen versus 0.71 for placebo) and uterine sarcoma (incidence rate per 1000 women-years of 0.17 for tamoxifen versus 0 for placebo).

    For stroke, the incidence rate per 1000 women-years was 1.43 for tamoxifen versus 1 for placebo.

    For pulmonary embolism, the incidence rate per 1000 women-years was 0.75 for tamoxifen versus 0.25 for placebo.

  • Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering tamoxifen to reduce their risk of developing breast cancer.
  • The benefits of tamoxifen outweigh its risks in women already diagnosed with breast cancer.

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tamoxifen
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(ta MOX i fen)

What is the most important information I should know about tamoxifen?

Do not use this medication without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Before using tamoxifen, tell your doctor if you are allergic to any drugs, or if you have liver disease, high triglycerides (fatty acids) in your blood, a history of cataract, or a history of stroke or blood clot. Also tell your doctor if you if you are receiving chemotherapy or radiation treatment.

If you are taking tamoxifen to reduce your risk of breast cancer, you may need to take your first dose while you are having a menstrual period. You may also need to have a pregnancy test before you start taking tamoxifen, to make sure you are not pregnant. Follow your doctor's instructions.

Taking tamoxifen may increase your risk of uterine cancer, stroke, or a blood clot in the lung, which can be fatal. Talk with your doctor about your specific risks in taking this medication.

To be sure this medication is not causing harmful effects, your doctor may want you to have mammograms and to perform routine breast self exams on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.

What is tamoxifen?

Tamoxifen blocks the actions of estrogen, a female hormone. Certain types of breast cancer require estrogen to grow.

Tamoxifen is used to treat and prevent some types of breast cancer.

Tamoxifen may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking tamoxifen?

Do not use this medication if you are allergic to tamoxifen.

Before using tamoxifen, tell your doctor if you are allergic to any drugs, or if you have:

  • liver disease;

  • high levels of triglycerides (fatty acids) in your blood;

  • a history of stroke or blood clot;

  • a history of cataract; or

  • if you are receiving chemotherapy or radiation treatment.

Taking tamoxifen may increase your risk of uterine cancer, stroke, or a blood clot in the lung, which can be fatal. Talk with your doctor about your specific risks in taking this medication. FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use tamoxifen without your doctor's consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Use a non-hormonal of birth control (such as a condom or a diaphragm and spermicide) while you are using this medication and for 2 months after your treatment ends. It is not known whether tamoxifen passes into breast milk or if it could harm a nursing baby. This medication may also slow breast milk production. Do not use this medication without telling your doctor if you are breast-feeding a baby.
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