Real-world safety study of posaconazole oral suspension in children under 13 years of age

doi:10.5246/jcps.2024.04.027

Abstract

Abstract:

In the present study, we aimed to investigate the safety of posaconazole oral suspension in children under 13 years of age. A retrospective analysis was conducted on six cases of pediatric patients with acute lymphocytic leukemia who received prophylactic or sequential treatment with posaconazole oral suspension. Among the six patients (four boys and two girls) with an average age of (8.67 ± 1.86) years, one child developed bilateral lower limb edema after 7 d of posaconazole oral suspension, and two children experienced elevated levels of liver enzymes during the course of treatment. In conclusion, common adverse reactions of posaconazole included liver damage and gastrointestinal symptoms. However, reports of lower limb edema in patients are rare. Further studies with larger sample sizes are needed to evaluate the safety of posaconazole oral suspension in children under 13 years of age.

Key words: Posaconazole oral suspension, Children, Lower limb edema, Elevated liver enzymes, Adverse reactions

Supporting:

Yingqiu Tu, Minfang Lai, Nan Zhong, Hongxiao Cao, Zhenggang Huang. Real-world safety study of posaconazole oral suspension in children under 13 years of age[J]. Journal of Chinese Pharmaceutical Sciences, 2024, 33(4): 352-357.

Figures/Tables 6

Table 1. Basic information of pediatric patients.

Table 2. Specific details of pediatric patients receiving posaconazole oral suspension.

Table 3. Summary of liver enzyme levels and other adverse reactions in pediatric patients using posaconazole oral suspension.

Table 4. Naranjo’s probability scale for adverse drug reaction (ADR) assessment.

Table 5. Naranjo’s assessment results for posaconazole oral suspension-induced lower limb edema.

Table 6. Naranjo’s assessment results for posaconazole oral suspension-induced hepatotoxicity.

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