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Seroquel and Pregnancy
In animal studies, Seroquel 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 taking this drug before making a recommendation in your particular situation.
Seroquel® (quetiapine fumarate) may not be safe for women who are pregnant. In animal studies that looked at the effects of the drug during pregnancy, Seroquel increased the chance of miscarriage and other problems.
What Is 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.
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.
In addition, 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 in some studies. However, it is important to note that animals do not always respond to medicines in the same way as humans. In fact, preliminary data (from 63 pregnancies) does not suggest that Seroquel causes birth defects in humans.
There have been reports of problems in newborns who were exposed to antipsychotic medications (including Seroquel) during the last trimester of pregnancy. These problems can include the following:
- Agitation
- Stiff muscles or floppy muscles
- Shakiness (tremor)
- Unusual sleepiness
- Breathing problems
- Feeding problems.
Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD