Soltamox (Tamoxifen Citrate) Issued Labeling Change
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.Tamoxifen Citrate powder
This is not the first time that tamoxifen has changed its contraceptive warnings.
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.