Dafflon is NOT Safe for an 8-Year-Old Child
Dafflon (diosmin) should not be used in an 8-year-old child, as the FDA drug label explicitly contraindicates its use in children under 12 years of age. 1
FDA Drug Label Contraindication
The official FDA labeling for Dafflon provides clear guidance:
- DO NOT USE in children under 12 years old 1
- The label specifically instructs to "consult a doctor" for this age group, but the primary directive is to avoid use 1
Lack of Pediatric Safety Data
The absence of approval for children under 12 reflects fundamental gaps in pediatric evidence:
- Medications require specific pediatric testing for each age group before use, and extrapolation from adult data is insufficient without dedicated pediatric studies 2, 3
- Children under 6 years (and by extension, those under 12 without specific approval) have documented increased risks of toxicity, medication errors, and accidental overdoses with medications lacking pediatric data 2
- The FDA mandates that clinical studies for drugs be conducted in each pediatric age group (newborns, infants, children, and adolescents), with separate studies of safety and dosing required for each group 3
Clinical Context
While diosmin has been studied for topical anti-inflammatory effects in adult skin models 4 and oral use for chronic venous insufficiency in adults 5, these studies do not establish safety in pediatric populations:
- No pediatric pharmacokinetic data exists for diosmin in the 8-year-old age group
- The absence of established dosing guidelines creates significant risk for inappropriate administration 2
- Adult safety data cannot be extrapolated to pediatric populations without specific pediatric studies 2
Recommendation
Do not administer Dafflon to this 8-year-old child. If treatment for venous insufficiency or related conditions is needed, consult a pediatric specialist to identify FDA-approved alternatives with established pediatric safety profiles for the specific indication 2.