From the Guidelines
Benzonatate should be used with caution during pregnancy and only when the potential benefits outweigh the risks, as it is classified as FDA Pregnancy Category C, indicating potential fetal harm. The use of Benzonatate during pregnancy is a concern due to the lack of adequate studies in pregnant women, despite its common use for cough suppression 1. According to the European Respiratory Journal, the FDA category for Benzonatate is [C], which means that animal reproduction studies have shown adverse effects on the fetus, but there are no controlled studies in pregnant women 1.
When considering the use of Benzonatate during pregnancy, it is essential to weigh the potential benefits against the risks. The medication works by numbing stretch receptors in the lungs to suppress cough, but it can cross the placenta and potentially affect the developing fetus. If cough treatment is needed during pregnancy, healthcare providers typically recommend trying safer alternatives first, such as:
- Honey (for non-diabetic patients)
- Saline nasal sprays
- Humidifiers
- Increased fluid intake
If medication is necessary, your doctor might consider other options with better established safety profiles. Always consult with your healthcare provider before taking any medication during pregnancy, as they can assess your specific situation and the severity of your symptoms to make an informed decision. The clinician should compare the benefits and risks of each medication, considering the maternal risk of therapy versus no therapy and the fetal risk of uncontrolled maternal disease with the risk of therapy on the newborn 1.
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.
- Pregnancy Category C indicates that benzonatate should be used with caution during pregnancy.
- The drug label states that it is not known whether benzonatate can cause fetal harm or affect reproduction capacity.
- Benzonatate should be given to a pregnant woman only if clearly needed 2.
- Due to the lack of information on the safety of benzonatate during pregnancy, its use should be approached with caution.
From the Research
Benzonatate Use During Pregnancy
- There is limited information available on the use of Benzonatate (Tessalon) during pregnancy, as most studies focus on benzodiazepines rather than non-benzodiazepine antitussives like Benzonatate.
- The available studies on benzodiazepines during pregnancy may not be directly applicable to Benzonatate, but they do provide some general insights into the potential risks and considerations of using central nervous system depressants during pregnancy 3, 4, 5.
- Some studies suggest that the use of certain medications during pregnancy, including those with central nervous system effects, should be approached with caution and carefully weighed against potential benefits 6, 7.
Potential Risks and Considerations
- The lack of specific data on Benzonatate use during pregnancy makes it difficult to determine the potential risks to the fetus or neonate.
- However, it is generally recommended that medications with central nervous system effects be used with caution during pregnancy, especially during the first trimester or near term, due to potential risks of fetal or neonatal sedation, respiratory depression, or other adverse effects 4, 5.
- The decision to use Benzonatate or any other medication during pregnancy should be made in consultation with a healthcare provider, taking into account the individual patient's circumstances and the potential benefits and risks of treatment.
Available Data on Similar Medications
- Studies on benzodiazepines, which are a different class of medications, suggest that their use during pregnancy should be carefully considered due to potential risks of fetal or neonatal effects, such as sedation, respiratory depression, or withdrawal symptoms 3, 4, 5.
- However, these studies may not be directly applicable to Benzonatate, and more specific data on its use during pregnancy are needed to fully understand its potential risks and benefits.