Levodropropizine Pregnancy Category
Levodropropizine does not have an established FDA pregnancy category, and there is insufficient human data to determine its safety profile during pregnancy.
Available Evidence
The provided evidence does not contain specific information about levodropropizine's pregnancy classification. While the drug has been studied for its antitussive (cough suppressant) properties in adult patients, the available research does not address its use in pregnancy 1, 2.
Understanding FDA Pregnancy Categories
The FDA pregnancy classification system (now replaced but still referenced) includes 3:
- Category A: Controlled studies show no risk to fetus
- Category B: Animal studies show no risk, but no adequate human studies OR animal studies show adverse effects not confirmed in human studies
- Category C: Animal studies show adverse effects with no adequate human studies, OR no studies available in animals or humans
- Category D: Evidence of human fetal risk, but benefits may outweigh risks in certain situations
- Category X: Contraindicated - proven fetal abnormalities
Clinical Recommendation
Given the absence of safety data, levodropropizine should be avoided during pregnancy unless the clinical situation is urgent and no safer alternatives exist 3.
Key Considerations:
Lack of human pregnancy data: No controlled studies or adequate observational data exist for levodropropizine use in pregnant women 1, 2
Risk-benefit assessment required: When drug treatment is necessary during pregnancy, the potential risk must be weighed against the possible benefit to the mother 3
Alternative antitussives: Consider medications with established pregnancy safety profiles before using levodropropizine 3
Common Pitfall:
Do not assume that absence of reported harm equals safety. The lack of pregnancy category assignment typically reflects insufficient data rather than proven safety 3.