Sarafem and Pregnancy

Sarafem and Pregnancy: An Overview

Sarafem^® (fluoxetine hydrochloride) is a pregnancy Category C medicine, meaning that Sarafem could potentially cause harm to your unborn child.

 

Sarafem and Pregnancy Category C

The U. S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that show side effects in the fetus in animal studies, but no human studies in pregnant women have been done. A pregnancy Category C medicine may still be given to pregnant women if the healthcare provider believes that the benefits to the pregnant woman outweigh the possible risks to the unborn child.

 

In animal studies, when rats were given Sarafem during pregnancy and breastfeeding, the baby rats weighed less and were less likely to survive. However, Sarafem did not cause any birth defects in the baby rats. In humans, there have been reports of problems in newborn babies born to mothers who were taking Sarafem. These problems can be as minor as irritability or as serious as seizures or lung problems.

 

Practically, there is no reason to take Sarafem during pregnancy. Sarafem is used to treat premenstrual dysphoric disorder (PMDD), which does not occur during pregnancy (since the menstrual cycle does not take place during pregnancy).