Abstract :
Aim: To assess the clinical safety of diphtheria antitoxin in patients with probable and confirmed diphtheria infection.
Materials and Methods: This was a single-center, observational study which included patients with probable and/or confirmed diphtheria infection. The skin sensitivity test for diphtheria antitoxin was performed in all the patients. The patients who were insensitive/ had ‘no reaction’ to the skin sensitivity test, medically optimal dose of the DAT (10000 IU/10 mL) was administered intravenously.
Results: A total of 203 patients were enrolled in this study, and 200 considered for safety assessments (females, n=104). All patients reported negative skin-sensitivity test. A total of 14 adverse events were reported in six patients (two patients reported three events each while remaining four patients reported two events each) either immediately (75%) or within 5-6 hours (12.5%) of administration of diphtheria antitoxin and therefore, these were considered related to the administration of the drug. These 14 adverse events were non-severe and the patients recovered without sequelae. No further adverse events were observed during the rest of the hospitalization period (4-5 days), after discharge from hospital and during follow-up until 15 days after administration of diphtheria antitoxin. There were no deaths and life-threatening serious adverse events observed.
Conclusion: The observations from the present study suggest that diphtheria antitoxin has a favorable safety profile and it can be essentially used in children as well as adults without any harm.
Keyword :
Adverse events, Diphtheria, Serious adverse events, Skin sensitivity