Alimta and Pregnancy

It is not recommended for women who are pregnant to take Alimta (pemetrexed), due to the risk of miscarriages and birth defects. Because the drug affects folic acid, it was shown to increase the risk of cleft palate and other problems in animal studies, even in small doses. Thus, it's important to use effective birth control while taking Alimta.

Is Alimta Safe During Pregnancy?

Alimta® (pemetrexed) is a prescription chemotherapy medication that is probably not safe for use during pregnancy. Based on information from animal studies, this medication could cause birth defects or miscarriages.
 

What Is Pregnancy Category D?

The U.S. Food and Drug Administration (FDA) uses a system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category D is given to medicines that have shown clear evidence of risk to the fetus in studies.
 
This is a stronger warning than a pregnancy Category C classification. However, a pregnancy Category D medicine may still be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh the possible risks to the unborn child.
 
Alimta was given a pregnancy Category D rating because of problems in animal studies. When given to pregnant mice, very small doses of Alimta (equivalent to just a fraction of the recommended dose for humans) increased the risk of miscarriages and birth defects, including cleft palate and other problems. This is expected, because Alimta interferes with folic acid.
 

Final Thoughts

Women should not intentionally become pregnant while taking Alimta, and women of childbearing potential should use effective birth control while on this medication. If you accidentally get pregnant while taking Alimta, it is important to seek the advice and care of your healthcare provider right away.
 
Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;
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