From the FDA Drug Label
Usage in Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with BENZONATATE It is also not known whether BENZONATATE can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. BENZONATATE should be given to a pregnant woman only if clearly needed.
Benzonatate should be used with caution in pregnant women, as its safety has not been established. It is recommended to use benzonatate in pregnant women only if clearly needed 1.
From the Research
Benzonatate should be used with caution in pregnant women and only when the potential benefits outweigh the risks, as there is limited safety data available in pregnancy, and it is classified as FDA Pregnancy Category C, meaning animal studies have shown adverse effects on the fetus, but there are no adequate studies in humans 2.
Key Considerations
- The lack of comprehensive human studies on benzonatate use during pregnancy is a significant concern, as it may pose a theoretical risk to the developing fetus 2.
- Healthcare providers typically prefer to use other cough remedies with better-established safety profiles during pregnancy, such as non-medication approaches like staying hydrated, using a humidifier, and trying honey (for women without gestational diabetes) 2.
- If medication is necessary, the lowest effective dose of benzonatate should be used for the shortest duration possible, and only under medical supervision 2.
Safety Profile
- Benzonatate is classified as FDA Pregnancy Category C, which means that animal studies have shown adverse effects on the fetus, but there are no adequate studies in humans to confirm or rule out these effects 2.
- The use of benzonatate during pregnancy should be carefully considered, taking into account the potential risks and benefits, and alternative treatments should be explored before resorting to medication 2.
Clinical Guidance
- Pregnant women with a severe cough that requires treatment should be advised to try non-medication approaches first, and if medication is necessary, the lowest effective dose of benzonatate should be used for the shortest duration possible, and only under medical supervision 2.
- Healthcare providers should maintain an open and respectful demeanor when counseling pregnant women about the use of benzonatate, and they should know how to access unbiased and authoritative information sources to provide reliable guidance on its use 3.