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Tecfidera and Pregnancy

Women who are pregnant or thinking of becoming pregnant should talk to their healthcare provider before taking Tecfidera (dimethyl fumarate). As a pregnancy Category C medication, Tecfidera may not be safe for use during pregnancy. Animal studies have shown that this drug may increase the risk for low fetal weights, delayed bone development, and various other complications.

Can Pregnant Women Take Tecfidera?

Tecfidera™ (dimethyl fumarate) is a prescription multiple sclerosis (MS) medication. Based on animal studies, this drug may not be safe for use during pregnancy.
 

What Is Pregnancy Category C?

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Tecfidera is classified as a pregnancy Category C medication.
 
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.
 
Tecfidera has not been studied in pregnant women. When given to pregnant rats in high doses, the drug reduced the weight of the rat fetuses and delayed bone development. It also increased the risk for miscarriage when given in high doses to pregnant rabbits. The doses that caused problems in the unborn animals also reduced the body weight of the mother rats and rabbits.
 
Giving high doses of Tecfidera to rats throughout pregnancy and during breastfeeding caused increased deaths, reduced body weight, and delayed sexual maturity in the newborn rats. Lower doses also caused brain and behavior-type problems in the baby rats.
 
However, 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 the benefits to the woman outweigh any possible risks to her unborn child.
 
Pregnancy and Pain

Tecfidera Medication Information

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