Dipentum and Pregnancy

In previous animal studies involving Dipentum and pregnancy, the drug caused low birth weight and underdeveloped organs in fetal rats. As a result, the FDA has classified it as a Pregnancy Category C medication. However, because animals and humans do not always respond to drugs in the same way, if you are taking Dipentum and pregnancy occurs, your healthcare provider will weigh the benefits and risks for your particular situation.

Is Dipentum Safe During Pregnancy?

Dipentum® (olsalazine sodium) may not be safe for pregnant women, though the full risks of taking this drug during pregnancy are not known. In previous animal studies, the drug caused developmental problems in the fetus.

Dipentum and 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. Pregnancy Category C is given to medicines that have not been studied in pregnant humans but that do appear 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.
When given to rats in high doses, Dipentum caused low birth weight and underdeveloped organs in the fetal 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 mother outweigh any possible risks to the unborn child.

Recommendations for Dipentum and Pregnancy

If you are pregnant or thinking about becoming pregnant while taking Dipentum, let your healthcare provider know. He or she will consider both the benefits and risks of taking the drug during pregnancy before making a recommendation for your particular situation.
Pregnancy and Pain

Dipentum Drug Information

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