Is Doxepin During Pregnancy Safe? -- An Overview
For women who are pregnant,
doxepin hydrochloride (
Sinequan®,
Silenor®) may not be safe. This is based on animal studies that looked at the effects of doxepin during pregnancy, as well as a few reports of birth defects in humans.
Doxepin and Pregnancy Risk
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 do appear to cause harm to the fetus in animal studies.
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a Pregnancy Category C rating.
Animal studies have not shown any negative effects to fetus, except when doxepin is used at very high doses. High doses of doxepin given to pregnant laboratory animals increased the risk of low fetal weight, structural abnormalities, and decreased newborn survival. One small study showed that doxepin use during pregnancy in humans may be associated with certain birth defects (including heart defects, cleft palate, and too many fingers or toes), although this has not been confirmed in other studies.
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.
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