Is Levocloperastine (antitussive) safe to use during pregnancy?

Safety of Levocloperastine During Pregnancy

Based on the available evidence, levocloperastine should be avoided during pregnancy due to insufficient safety data and the availability of better-studied alternatives for cough management.

Safety Classification and Risk Assessment

• There is no specific FDA pregnancy category classification for levocloperastine, which indicates a lack of adequate safety data for use during pregnancy 1
• Most medications, including antitussives, should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, following the general principle of medication use in pregnancy 2, 3
• The absence of specific pregnancy safety data for levocloperastine is concerning, as approximately one-quarter of medications lack sufficient evidence to characterize their safety profile in pregnancy 4

Pharmacological Considerations

• Levocloperastine is an antitussive agent that acts both centrally on the cough center and peripherally on receptors in the tracheobronchial tree 5
• While levocloperastine has shown efficacy in treating chronic cough in the general population, its safety profile specifically during pregnancy has not been well-established 5
• The drug label does not provide specific guidance for use during pregnancy, which should raise caution about its administration to pregnant women 1

Alternative Treatment Options

• For pregnant women requiring cough management, medications with established safety profiles should be considered first 2, 6
• Second-generation antihistamines may be preferable if an antihistamine is needed for cough management during pregnancy due to their better-documented safety profile 6
• If medication is necessary, the lowest effective dose should be used for the shortest duration possible to minimize potential risks 6

Risk-Benefit Assessment

• The decision to use any medication during pregnancy must balance maternal benefit against potential fetal risk 2
• Given the self-limiting nature of many coughs and the availability of alternative treatments with better-established safety profiles, the risk-benefit ratio does not favor using levocloperastine during pregnancy 3
• Non-pharmacological approaches to cough management (hydration, humidification, honey for non-diabetic patients) should be considered first-line before resorting to medications with limited safety data 2

Important Caveats

• If cough is severe and significantly impacts maternal health or is a symptom of a more serious condition, the risk-benefit assessment may change, and treatment becomes more necessary 2
• Always consider the underlying cause of the cough, as treating the primary condition may be more appropriate than symptomatic management 2
• Any medication use during pregnancy should be discussed with a healthcare provider who can provide individualized recommendations based on the specific clinical situation 2, 6

Recommendations for Clinical Practice

• Avoid levocloperastine during pregnancy, especially in the first trimester when organogenesis occurs 2, 3
• Consider safer alternatives with established pregnancy safety data if pharmacological treatment is necessary 6
• Document the discussion of risks and benefits if treatment is deemed necessary despite limited safety data 2
• Monitor for any adverse effects if the medication must be used in situations where benefits clearly outweigh potential risks 2