Context: In 2006, the American Association of Poison Control Centers (AAPCC) published an out of hospital guideline for diphenhydramine overdoses in children. This guideline has not been validated.
Objective: Our objective was to determine the incidence of serious clinical effects or use of medical treatments after unintentional diphenhydramine ingestions in children. We sought to determine if patients with less than 7.5 mg/kg ingestions developed medical complications of diphenhydramine toxicity.
Materials And Methods: In our observational case series, we searched 7 years of data (2000-2006) in the Texas Poison Center Network for diphenhydramine using the AAPCC generic codes. We included only acute, single ingestions of diphenhydramine in children under 6 years old. We included only patients with a recorded weight, known amount of ingestant, and known follow-up. We defined "serious clinical effects" as hallucinations, seizure, wide QRS on electrocardiogram, wide complex dysrhythmia, any conduction block, hypotension, hypertension, rhabdomyolysis, pyrexia, dystonia, coma, respiratory depression, or death. One trained abstractor reviewed the data and entered it into an electronic data collection form. Twenty percent of the charts were audited for abstractor agreement.
Results: Our search resulted in 928 cases. Of these, 305 were included in our study. Of the patients who ingested doses less than 7.5 mg/kg, 99.7% (299/300) did not require critical treatments or were without serious clinical effects. One child was admitted. Five children ingested doses of more than 7.5 mg/kg. All five were observed in the emergency department and discharged home. Two patients had serious clinical effects of hallucinations, one of which ingested more than 7.5 mg/kg. No child required critical treatments. Our agreement on chart review for 20% of the cases was very good for "serious clinical effects" (kappa, 0.79; 95% CI, 0.39-1.0) and excellent for "critical treatments" (kappa, 1.0).
Conclusion: Based on our observational case series, 99.6% of patients who reportedly ingested doses less than 7.5 mg/kg did not develop serious clinical effects or require admission. Pediatric ingestions over 7.5 mg/kg were uncommon in our study population. Serious clinical effects, critical treatments, and admission from diphenhydramine were rare in children under 6 years old.
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http://dx.doi.org/10.3109/15563650.2010.497149 | DOI Listing |
Clin Transl Sci
January 2025
Clinical Pharmacology, R&D China, AstraZeneca, Shanghai, China.
Respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract infection (LRTI) in infants worldwide. Nirsevimab, an extended half-life monoclonal antibody against RSV, is approved in China for the prevention of RSV lower respiratory tract disease in infants; however, global nirsevimab trials did not enroll Chinese infants. To inform the investigation of nirsevimab for the prevention of RSV LRTI in Chinese infants, this Phase I, randomized, placebo-controlled trial evaluated the pharmacokinetics (PK) and safety of nirsevimab in healthy Chinese adults.
View Article and Find Full Text PDFUnited European Gastroenterol J
December 2024
The Sheba Talpiot Medical Leadership Program, Sheba Medical Center, Ramat-Gan, Israel.
Background: Gastrointestinal perforations have been reported in a small number of rheumatoid arthritis (RA) patients treated with Janus kinase (JAK) inhibitors in clinical trials. However, large-scale postmarketing data repositories are needed to further investigate this potentially rare but serious adverse event.
Methods: A retrospective, pharmacovigilance study of the FDA adverse event reporting system (July 2014 to September 2023) assessing the reporting of gastrointestinal perforations following JAK inhibitors compared to biological disease-modifying antirheumatic drugs (bDMARDs) in RA patients.
Background: Antiplatelet drugs, such as clopidogrel, ticagrelor, prasugrel, and acetylsalicylic acid, may be associated with a risk of adverse events (AEs). Vanessa's Law was enacted to strengthen regulations to protect Canadians from drug-related side effects (with mandatory reporting of serious adverse events [SAEs]).
Objective: To determine whether Vanessa's Law has led to an increase in SAE reporting among antiplatelet users.
Front Endocrinol (Lausanne)
December 2024
Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
Diabetic nephropathy (DN), as the most serious minor vascular complication of diabetes, imposes a significant socioeconomic and medical cost around the world, and its prevention and treatment are a major challenge in the current medical community. Observational studies and randomized controlled trials have revealed protective and risk factors for some DN. However, the conclusions of these researches may be influenced by several types of confounding.
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