Colazal and Pregnancy

While no human studies have been done on Colazal and pregnancy, animal studies suggest that the drug is most likely safe for women who are pregnant. However, it is important to note that animals and humans do not always respond to medications in the same way. Therefore, if you are taking Colazal and pregnancy occurs, your healthcare provider will consider the risks and benefits for your particular situation.

 

Is Colazal Safe During Pregnancy?

Colazal® (balsalazide disodium) is probably safe for pregnant women, though the full risks of taking this medicine during pregnancy are not known.
 

Colazal and Pregnancy Category B

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 B is given to medicines that have not been studied in pregnant humans but that do not appear cause harm to the fetus in animal studies.
 
When given to pregnant rats and rabbits, Colazal did not cause any problems. However, it is important to note that animals do not always respond to medicines in the same way that humans do. Also, the full risks of using Colazal during pregnancy are not known. Therefore, Colazal should be given to a pregnant woman only if her healthcare provider believes that the benefits to the mother outweigh any possible risks to the unborn child.
 

Recommendations for Colazal and Pregnancy

If you are taking Colazal and pregnancy occurs (or you are thinking of becoming pregnant), let your healthcare provider know. He or she will consider the benefits and risks of taking the drug during pregnancy before making a recommendation for your particular situation.
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;