Clomipramine and Pregnancy

There are some situations where it may not be safe to take clomipramine, and pregnancy is one of them. Although clomipramine did not appear to cause birth defects in animal studies, it did appear to be linked to heart birth defects in humans. Also, there have been reports of withdrawal symptoms (such as seizures, blue skin, and muscle weakness) in babies born to mothers who took clomipramine during the third trimester of pregnancy.

 

Is Clomipramine During Pregnancy Safe? -- An Overview

For people who are pregnant, clomipramine hydrochloride (Anafranil®) may not be safe. This is based on animal and human studies that looked at the effects of clomipramine during pregnancy.
 

Clomipramine 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 show side effects to the fetus in animal studies, but no adequate human studies in pregnant women have been done. A pregnancy Category C medicine may still be given to a pregnant woman if the healthcare provider believes that the benefits to the pregnant woman outweigh the possible risks to the unborn child.
 
In animal studies, clomipramine did not cause birth defects. However, recent studies have suggested that clomipramine may be linked to heart birth defects in humans.
 

Clomipramine and Pregnancy: Third Trimester Concerns

There have been reports of withdrawal symptoms in babies born to mothers who took clomipramine during the third trimester of pregnancy. These newborns experienced a number of symptoms, including:
 
  • Jitteriness
  • Shakiness (tremors)
  • Seizures
  • Blue skin
  • Muscle tension or muscle weakness.
     
(Clomipramine and Pregnancy Continued: Page 2)
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;