Maxalt and Pregnancy

The FDA has classified Maxalt as a pregnancy Category C medication, meaning that the drug did appear to cause harm to the fetus in previous animal studies. A pregnant woman may take Maxalt if her healthcare provider believes that its benefits outweigh the possible risks to her unborn child. If you are taking Maxalt and pregnancy occurs, you should let your healthcare provider know.

 

An Overview of Maxalt and Pregnancy

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

Maxalt 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.
 
Maxalt was given a pregnancy Category C rating based on studies in pregnant animals. For example, when Maxalt was given to pregnant rats during pregnancy and breastfeeding, the baby rats weighed less and were less likely to survive. There is also evidence that Maxalt decreased the baby rats' ability to learn. No birth defects were seen in the studies that looked at using Maxalt in pregnant rats and rabbits.
 
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.
 
(Maxalt 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;