Axert and Pregnancy

The FDA has classified Axert as a pregnancy Category C medication, meaning that it did appear to cause harm to the fetus in previous animal studies. When Axert was given to pregnant rats during pregnancy and breastfeeding, the number of embryo deaths increased and the baby rats weighed less and suffered from bone changes. If you are pregnant or thinking of becoming pregnant, you should be sure to talk to your healthcare provider about Axert and pregnancy. He or she may still prescribe Axert if the benefits outweigh the risks.

 

An Overview of Axert and Pregnancy

For women who are pregnant, Axert® (almotriptan maleate) may not be safe. This is based on animal studies that looked at the effects of Axert during pregnancy.
 

Axert 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.
 
Axert was given a pregnancy Category C rating based on studies in pregnant animals. For example, when Axert was given to pregnant rats during pregnancy and breastfeeding, the number of embryo deaths increased and the baby rats weighed less. Also, Axert caused bone changes in the baby rats.
 
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.
 
(Axert 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;