Imitrex has not been tested in pregnant humans, so the drug's possible effects on an unborn child are unknown. The FDA has classified Imitrex as a pregnancy Category C medication, meaning that the drug may not be safe to take during pregnancy. However, Imitrex did cause fetal problems in previous animal studies.
An Overview of Imitrex and Pregnancy
Imitrex® (sumatriptan succinate) may not be safe for women who are pregnant. This is based on animal studies that looked at the effects of Imitrex during pregnancy.
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.
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.
Recommendations on Pregnancy and Imitrex
For your safety, let your healthcare provider (prior to taking Imitrex) know if you are pregnant or thinking about becoming pregnant. Your healthcare provider will consider both the benefits and the risks of taking this drug before making a recommendation for your particular situation.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Imitrex Tablets [package insert]. Research Triangle Park, NC: GlaxoSmithKline;2007 April.
Imitrex Injection [package insert]. Research Triangle Park, NC: GlaxoSmithKline;2007 April.
Imitrex Nasal Spray [package insert]. Research Triangle Park, NC: GlaxoSmithKline;2007 April.
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