Benzonatate and Pregnancy

No studies have been performed on pregnant women using benzonatate (Tessalon), so it is difficult to say whether the drug is safe for such women to take. The Food and Drug Administration has given this product a pregnancy Category C rating, which means benzonatate may be prescribed if the benefits outweigh the risks.

Can Pregnant Women Use Benzonatate?

Benzonatate (Tessalon®) is a prescription cough medication. There is no information available about the safety of this medication 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. 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.
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Benzonatate was given a pregnancy Category C rating because it has not been studied in any pregnant animals or women. There is simply no information available to suspect that this drug may (or may not) be safe for use in such women.
It is important to note, however, that a pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.

Benzonatate and Pregnancy: Final Thoughts

If you are pregnant or thinking about becoming pregnant, let your healthcare provider know. Your healthcare provider will consider both the benefits and risks benzonatate presents before making a recommendation in your particular situation.
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