Is Imitrex Safe During Pregnancy?

Some people may wonder, "Is Imitrex safe during pregnancy?" The FDA has classified Imitrex as a pregnancy Category C medication, meaning that the drug may not be safe to take during pregnancy. Imitrex and pregnancy have not been tested together in humans, so the drug's possible effects on an unborn child are unknown. However, Imitrex did cause problems to fetuses in previous animal studies.

An Overview of Imitrex and Pregnancy

For people who are pregnant, Imitrex® (sumatriptan succinate) may not be safe. This is based on animal studies that looked at the effects of Imitrex during pregnancy.
 

Imitrex 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.
 
Imitrex was given a pregnancy Category C rating based on studies in pregnant animals. For example, when Imitrex was given to pregnant rabbits during early pregnancy, there was an increase in deaths of the developing embryo. This risk was not seen when Imitrex was tested on rats. There were, however, an increased number of blood vessel problems in the studies on rats.
 
It is important to note, however, 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 the unborn child.
 
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;
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