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[Adverse effects of oxybutynin chloride (Ditropan) in pediatrics]
A P Jonville1, J P Dutertre, M Barbellion
1Service de Pharmacologie Clinique, Hôpital Bretonneau, Tours.
Background:
The side effects of oxybutynin chloride (Ditropan) often include atropinic and allergic reactions. Their relative frequency in children merits a nationwide investigation.
Methods:
All the side effects of Ditropan reported to the French Regional ADR monitoring centers and to the pharmaceutical firm Debat between January 1985 and June 1990 were analysed. Only 87 effects of the 286 side effects reported in adults and children occurred with sufficient frequency in 84 children to warrant study.
Results:
The 84 children (38 males, 43 females, 3 of unknown sex) were 30 months to 15 years old (mean: 6.5 years); 13 of them were less than 5 years. The mean dose of Ditropan prescribed was 0.5 +/- 0.12 mg/kg/day. 52 children developed atropinic symptoms, 20 skin and/or allergic reactions and 15 various other manifestations. These side effects required admission to hospital in 14% of cases. The side effects were 4 times more frequent in children (1/4,000 regulations) than in adults.
Conclusions:
The higher frequency of atropinic reactions in children may be due to the higher dosage of the drug used and/or to differences in hydroxylation metabolism, that is genetically determined in adults. New recommendations for use of this drug are proposed.