Amerge and Pregnancy

The FDA has classified Amerge as a pregnancy Category C medication, meaning that it may not be safe to take while pregnant. In studies involving Amerge and pregnancy, the drug caused birth defects and miscarriages when it was given to pregnant animals. However, humans do not always respond to medicines in the same way that animals do, and a doctor may recommend taking Amerge during pregnancy if he or she believes the benefits of the drug outweigh the risks it poses.

 

An Overview of Amerge and Pregnancy

Amerge® (naratriptan hydrochloride) may not be safe for women who are pregnant. Studies conducted involving animals showed that Amerge caused birth defects and miscarriages in rats and rabbits.
 

Amerge 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.
 
Amerge was given a pregnancy Category C rating because it appeared to have adverse effects in studies involving pregnant animals. For example, Amerge has caused birth defects and miscarriages in rats and rabbits. Also, the newborn rats and rabbits were less likely to survive and grew more slowly than normal.
 
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a healthcare provider may prescribe a pregnancy Category C medicine for a pregnant woman if the benefits to the woman appear to outweigh any possible risks to the unborn child.
 
(Amerge 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;