Aplenzin and Pregnancy

The FDA has classified Aplenzin (bupropion hydrobromide) as a pregnancy Category C medication, meaning that it may not be safe for pregnant women to take it. Animal studies indicate that the active ingredient in this medicine may cause birth defects or other problems. However, if the benefits outweigh the risks, a healthcare provider may decide to prescribe this drug to a pregnant woman.

Is Aplenzin Safe During Pregnancy?

Aplenzin™ (bupropion hydrobromide) is a prescription depression medication. Although animal studies show that Aplenzin might be dangerous during pregnancy, very preliminary survey-type data suggest that these risks might not apply to humans.

What Is 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 have not been studied in pregnant humans, but 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.
In animal studies where pregnant rabbits were given bupropion (the active ingredient of Aplenzin), there was a slightly increased risk of fetal malformations and lower fetal weights.
In humans, preliminary studies suggest that bupropion may not cause any problems during pregnancy. One small survey-type study suggested that bupropion might increase the risk of miscarriages, but this increased risk was not seen when women taking bupropion for depression only (instead of for smoking cessation) were included in the analysis.
It is important to note that depression in the mother may also not be healthy for a baby. Therefore, a pregnant woman may be given Aplenzin if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.
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