Soltamox (Tamoxifen Citrate) Issued Labeling Change

April 9, 2019

Women no longer require nine months of contraception post cessation of the drug.

Women taking Soltamox (tamoxifen citrate) are no longer advised to take contraception or otherwise avoid pregnancy for nine months after they stop taking it. 

Recent postmarketing reports submitted to the FDA and published literature indicate that women who ended their tamoxifen regimen and subsequently became pregnant within two to nine months did not experience any negative drug-associated effects such as birth defects or other maternal or fetal problems.

This is not the first time that tamoxifen has changed its contraceptive warnings. 

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The FDA extended its original mandatory two-month contraceptive period after cessation of tamoxifen to nine months in September of 2018. 

This revision is not final. Should drug-related adverse effects be reported, the FDA would likely issue a reinstallation of the contraceptive period. 

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Soltamox is an oral solution indicated for adult women with early stage estrogen receptor-positive metastatic breast cancer or as adjuvant treatment for breast cancer. Soltamox can also be used to reduce the risk of invasive breast cancer following breast surgery and radiation in adult women with ductal carcinoma in situ (DCIS), and to reduce the incidence of breast cancer in high-risk patients.

The drug is not recommended for women who have already developed breast cancer, because serious life-threatening risks including uterine malignancies, stroke, and pulmonary embolism which outweigh any potential benefits of the drug.

Women with metastatic breast cancer should take between 20 mg and 40 mg of the drug per day, with dosages higher than 20 mg to be split evenly between morning and evening. 

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If prescribed for the adjuvant treatment of breast cancer, DCIS, or the reduction of breast cancer, dosages should not exceed 20 mg per day.

Soltamox is contraindicated for patients with known hypersensitivity to tamoxifen or any other Soltamox ingredients, patients who require concomitant warfarin therapy, those with a history of deep vein thrombosis or pulmonary embolism, and if the reason for use includes reduction of breast cancer in high-risk patients or after DCIS treatment. 

Some of the most common adverse events reported while using Soltamox include hot flashes, mood disturbances, vaginal discharge, vaginal bleeding, nausea, and fluid retention. 

Full Prescribing Information