Seroquel and Pregnancy

In animal studies on Seroquel and pregnancy, the drug caused low birth weight, slow development, and increased miscarriages. As a result, the FDA has classified it as a pregnancy Category C medication. If you are taking Seroquel and pregnancy occurs, your healthcare provider will compare the benefits and risks of Seroquel before making a recommendation for your particular situation.

 

Is Seroquel Safe During Pregnancy?

Seroquel® (quetiapine fumarate) may not be safe for women who are pregnant. In previous animal studies that looked at the effects of the drug during pregnancy, Seroquel increased the chance of miscarriage and other problems.
 

Seroquel and Pregnancy Category C

The U.S. Food and Drug Administration (FDA) uses a 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 have not been studied in pregnant humans but that do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
 
When given to pregnant rats and rabbits, Seroquel caused low birth weight, slow development, and miscarriages. However, it is important to note that animals do not always respond to medicines in the same way as humans. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if her healthcare provider believes that the benefits to her outweigh any possible risks to the unborn child.
 

Seroquel and Pregnancy: Recommendations

If you are taking Seroquel and pregnancy occurs (or you are thinking of becoming pregnant while taking the drug), let your healthcare provider know. He or she will consider both the benefits and risks of taking it during pregnancy before making a recommendation for your particular situation.
 
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;