Saphris and Pregnancy

Based on the results of animal studies, the FDA gave Saphris a pregnancy Category C rating. This means that the medication could cause problems during pregnancy, such as an increased risk for miscarriages and a lower-than-normal birth weight. However, in some cases, if the benefits to the woman outweigh the risks to the fetus, Saphris (asenapine) may be prescribed.

Can I Take Saphris If I'm Pregnant?

Saphris® (asenapine) is a prescription antipsychotic medication used to treat schizophrenia and bipolar disorder. Based on the results of animal studies, Saphris may not be safe for use in pregnant women.

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.
Medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
When given to rats in pregnancy and while breastfeeding, high doses of Saphris caused the following problems:
  • Increased miscarriages
  • Increased newborn death
  • Decreased weight and survival of the offspring.
However, it is important to note that animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category C medicine such as Saphris may be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.

Final Thoughts

If you are pregnant or thinking about becoming pregnant, let your healthcare provider know. Your healthcare provider will consider the benefits and risks of taking this drug during pregnancy before making a recommendation on Saphris in your particular situation.
Pregnancy and Pain

Saphris Medication Information

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