Amitriptyline and Pregnancy

There are some situations in which it may not be safe to take amitriptyline, and pregnancy is one of them. The FDA has classified amitriptyline as a pregnancy Category C medication, meaning that it does appear to cause harm to the fetus in animal studies. There have also been some reports of birth defects -- such as problems with the arms or legs, developmental delay, and problems with the brain -- in the babies of women who took amitriptyline during pregnancy.

Amitriptyline Drug Information

Is Amitriptyline During Pregnancy Safe? -- An Overview

For people who are pregnant, amitriptyline hydrochloride (Elavil^®) may not be safe. This is based on animal studies that looked at the effects of amitriptyline during pregnancy and a few reports of birth defects in humans.

Amitriptyline and 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.

Amitriptyline has been given a pregnancy Category C rating for a couple of reasons. First, there have been a few reports of birth defects in babies whose mothers were taking amitriptyline while pregnant. Some of these birth defects included problems with the arms or legs, developmental delay, and problems within the brain.

Second, when given to pregnant mice, hamsters, rats, and rabbits at high doses, amitriptyline also caused birth defects. However, 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 her healthcare provider believes that its benefits outweigh any possible risks to her unborn child.

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