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 is classified as Pregnancy Category C. The safety of benzonatate in pregnancy has not been established, and it should be used only if clearly needed 1. Due to the lack of information on its effects on the fetus, benzonatate should be used with caution in pregnant women.
From the Research
Benzonatate should be avoided during pregnancy due to limited studies evaluating its safety and potential risks to the developing fetus. The safety of benzonatate in pregnant women has not been well established, and it is classified as FDA Pregnancy Category C, meaning that animal studies have shown adverse effects on the fetus, but there are no adequate studies in humans 2. According to a systematic review of the literature, there are substantial limitations within existing evidence pertaining to the safety and clinical effectiveness of benzonatate, and rising safety concerns should bring closer scrutiny upon its prescription 2.
Key Considerations
- The lack of adequate studies in humans makes it difficult to rule out the risks to the developing fetus 2
- Animal studies have shown adverse effects on the fetus, which is a concern for pregnant women 2
- Benzonatate is classified as FDA Pregnancy Category C, indicating potential risks to the fetus 2
- A systematic review of the literature highlights the need for large observational studies or randomized trials to better characterize the role and value of benzonatate in modern medical practice 2
Alternative Approaches
- Non-medication approaches, such as staying hydrated, using a humidifier, or trying honey and lemon in warm water, may be effective in managing cough during pregnancy
- If medication is needed for a persistent cough, healthcare providers may recommend safer alternatives with more established safety profiles in pregnancy 2
- It is essential to consult with a healthcare provider before taking any medication during pregnancy to weigh the potential benefits against the possible risks based on the specific situation 2