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.
