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Similar hematologic changes in children receiving trimethoprim-sulfamethoxazole or amoxicillin for otitis media
Insights
Trimethoprim-sulfamethoxazole (TMP-SMZ) and amoxicillin did not cause significant hematologic changes in children with acute otitis media. Lower neutrophil counts observed were within normal ranges for Black children, suggesting current criteria may be inappropriate for adverse drug effect detection.
Area of Science:
- Pediatrics
- Hematology
- Pharmacology
Background:
- Acute otitis media is common in children.
- Antibiotic selection is crucial for treatment.
- Hematologic effects of antibiotics require monitoring.
Purpose of the Study:
- To evaluate hematologic changes in Black children treated for acute otitis media.
- To compare the effects of trimethoprim-sulfamethoxazole (TMP-SMZ) and amoxicillin on blood counts.
- To assess the appropriateness of current criteria for adverse drug effects on neutrophil counts.
Main Methods:
- Randomized trial involving 90 Black children.
- Treatment with a 10-day course of either TMP-SMZ or amoxicillin.
- 23-day evaluation of hematologic parameters, including absolute neutrophil counts.
Main Results:
- Absolute neutrophil counts <1500/mm3 occurred in 57% of TMP-SMZ and 54% of amoxicillin recipients.
- Leukopenia, thrombocytopenia, and anemia were negligible in both groups.
- Neutrophil counts recovered in most children within the study period; six required additional recovery time.
Conclusions:
- Observed decreased neutrophil counts were within the normal range for healthy Black children.
- A neutrophil count <1500/mm3 may not be an appropriate indicator of adverse drug effects in this population.
- Neither TMP-SMZ nor amoxicillin demonstrated hematologic effects that warrant limiting their use in susceptible infections.
Abstract:
We report the hematologic changes in 90 black children who were randomized to receive a 10-day course of either trimethoprim-sulfamethoxazole (TMP-SMZ) or amoxicillin as therapy for acute otitis media. Absolute neutrophil counts less than 1500/mm3 developed at least once during the 23-day evaluation in 28 (57%) of the 49 children given TMP-SMZ and in 22 (54%) of the 41 who received amoxicillin. Incidence of leukopenia, thrombocytopenia, and anemia was negligible in both groups. Pancytopenia did not occur in any child. Absolute neutrophil counts had increased to greater than 1500/mm3 by the end of the study period in all of the patients but six, whose recovery required an additional 1 to 63 days. Decreased neutrophil counts in antibiotic-treated subjects remained within the range of findings for healthy black children, suggesting that a count less than 1500/mm3 may be an inappropriate criterion for an adverse drug effect. Neither TMP-SMZ nor amoxicillin produced hematologic effects that would detract from their continued use in children with infections caused by antibiotic-susceptible organisms.