Oleptro and Pregnancy
The FDA has classified Oleptro (trazodone ER) as a pregnancy Category C medication, meaning that it may not be safe for pregnant women to take it. Animal studies indicate that high doses of this medicine may cause birth defects or miscarriages. However, if the benefits outweigh the risks, a healthcare provider may decide to prescribe this drug to a pregnant woman.
Is Oleptro Safe During Pregnancy?Oleptro™ (trazodone ER) is a prescription depression medication. Although animal studies show that this drug might be dangerous during pregnancy, very preliminary survey-type data suggest that these Oleptro 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.
When given to pregnant rats, very high doses of trazodone (the active ingredient in Oleptro) increased the risk of miscarriages. One study suggested that high doses of trazodone given to pregnant rabbits might increase the risk of birth defects.
It is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child. Although no formal studies have been done using trazodone in pregnant humans, reports from women who used the medication during pregnancy do not appear to suggest an increased risk of any problems.