Can benzonatate be used safely in pregnancy?

Benzonatate Use in Pregnancy

Benzonatate should only be used during pregnancy if clearly needed, as it is classified as Pregnancy Category C with no adequate human safety data available.

FDA Classification and Safety Profile

• The FDA classifies benzonatate as Pregnancy Category C, meaning animal reproduction studies have not been conducted, and it is unknown whether benzonatate can cause fetal harm or affect reproductive capacity 1.
• The drug should be given to a pregnant woman only if clearly needed, as there is insufficient evidence to determine safety during pregnancy 1.
• No controlled studies in pregnant women exist to establish the safety profile of benzonatate during any trimester 1.

Risk-Benefit Considerations

• The general principle in pregnancy is that no drug is entirely without side-effects, and great caution should be taken when prescribing 2.
• When medications must be used during pregnancy, the therapeutic value must be weighed against theoretical adverse effects on the fetus before making treatment decisions 3.
• The risks of maternal hypoxemia and uncontrolled symptoms may exceed theoretical medication risks in some clinical scenarios, though this principle applies primarily to essential medications like asthma treatments 4.

Clinical Decision-Making Algorithm

Step 1: Assess necessity

• Determine if cough suppression is medically necessary or if the condition can be managed with non-pharmacologic measures 2.

Step 2: Consider alternatives

• Explore safer alternatives with better-established pregnancy safety profiles before resorting to benzonatate 5.
• For respiratory symptoms in pregnancy, medications with extensive human safety data should be prioritized 4.

Step 3: Timing considerations

• If benzonatate must be used, avoid first trimester exposure when the risk of congenital malformations is greatest, as this is the period of organogenesis 5.
• Use the lowest effective dose for the shortest possible duration 3.

Step 4: Documentation

• Document the risk-benefit discussion with the patient, including the limited safety data available 6.

Common Pitfalls to Avoid

• Failing to discuss alternative treatment options with better established safety profiles is a common error when prescribing medications with limited pregnancy data 5.
• Do not assume that over-the-counter or commonly prescribed medications are automatically safe in pregnancy 2.
• Avoid prescribing benzonatate without first attempting non-pharmacologic cough management strategies 2.

Lactation Considerations

• It is not known whether benzonatate is excreted in human milk 1.
• Because many drugs are excreted in breast milk, caution should be exercised when benzonatate is administered to a nursing woman 1.