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Safety and tolerability of fluconazole in children
1Infectious Diseases Unit, Great Ormond Street Hospital for Children NHS Trust, London, United Kingdom. vnovelli@compuserve.com
Insights
Fluconazole demonstrated a favorable safety profile in pediatric patients, with most treatment-related side effects being mild and infrequent. This antifungal medication is well-tolerated in children, mirroring adult safety data.
Area of Science:
- Pediatric Pharmacology
- Infectious Diseases
- Clinical Safety
Background:
- Fluconazole is a widely used antifungal agent.
- Pediatric safety data for fluconazole is crucial due to its use in children, often with serious underlying conditions.
Purpose of the Study:
- To assess the safety and tolerability of fluconazole in pediatric patients (0-17 years).
- To evaluate treatment-related side effects, laboratory abnormalities, and drug interactions in children receiving fluconazole.
Main Methods:
- Analysis of data from 12 clinical studies involving 562 children treated with fluconazole.
- Evaluation of side effects, laboratory values (ALT, AST, ALP), and concomitant medication use.
- Comparison of fluconazole safety with other antifungals in a subset of controlled studies.
Main Results:
- 10.3% of children experienced treatment-related side effects, primarily gastrointestinal (7.7%) and skin-related (1.2%).
- Liver and biliary system side effects were rare (0.5%).
- Treatment discontinuation due to side effects occurred in 3.2% of patients.
- Transient elevations in liver enzymes were uncommon.
- No significant drug interactions were observed despite frequent concomitant medication use.
Conclusions:
- Fluconazole is well-tolerated in the pediatric population, including immunocompromised children with severe underlying diseases.
- The safety profile in children is comparable to that observed in adults.
- Fluconazole is a safe and effective antifungal option for pediatric use.
Abstract:
The safety profile of fluconazole was assessed for 562 children (ages, 0 to 17 years) comprising 323 males and 239 females. The data are derived from 12 clinical studies of fluconazole as prophylaxis or treatment for a variety of fungal infections in predominantly immunocompromised patients. Most children received multiple doses of fluconazole in the range of 1 to 12 mg/kg of body weight; a few received single doses. Administration was mainly by oral suspension or intravenous injection. Overall, 58 (10.3%) children reported 80 treatment-related side effects. The most common side effects were associated with the gastrointestinal tract (7.7%) or skin (1.2%). Self-limiting, treatment-related side effects affecting the liver and biliary system were reported in three patients (0.5%). Overall, 18 patients (3.2%) discontinued treatment due to side effects, mainly gastrointestinal symptoms. Dose and age did not appear to influence the incidence and pattern of side effects. Treatment-related laboratory abnormalities were uncommon, the most frequent being transient elevated alanine aminotransferase (4.9%), aspartate aminotransferase (2.7%), and alkaline phosphatase (2.3%) levels. Although 98.6% of patients were taking concomitant medications, no clinical or laboratory interactions were observed. The safety profile of fluconazole was compared with those of other antifungal agents, mostly oral polyenes, by using a subset of data from five controlled studies. Side effects were reported by more patients treated with fluconazole (45 of 382; 11.8%) than by those patients treated with comparable agents (25 of 381; 6.6%); vomiting and diarrhea were the most common events in both groups. The incidence and type of treatment-related laboratory abnormalities were similar for the two groups. In conclusion, fluconazole was well tolerated by the pediatric population, many of whom were suffering from severe underlying disease and were taking a variety of concurrent medications. The safety profile of fluconazole in children mirrors the excellent safety profile seen in adults.