Titre du document / Document title

Deaths associated with inappropriate intravenous colchicine administration

Auteur(s) / Author(s)

BONNEL Renan A. ⁽¹⁾ ; VILLALBA Maria L. ⁽²⁾ ; KARWOSKI Claudia B. ⁽¹⁾ ; BEITZ Julie ⁽¹⁾ ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ Office of Drug Safety, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland, ETATS-UNIS
⁽²⁾ Division of Anti-Inflammatory, Analgesic and Ophthalmic Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration Rockville, Maryland, ETATS-UNIS

Résumé / Abstract

Intravenous (IV) colchicine is occasionally prescribed for the treatment of acute gouty arthritis. The Food and Drug Administration (FDA) recently received a report of death in a patient that was associated with inappropriate IV dosing of colchicine. This report prompted further investigation of other deaths associated with IV colchicine use in the FDA Adverse Event Reporting System (AERS) and the medical literature. A total of 20 deaths were identified. Eight patients were females, 11 were males, and the gender was unknown in 1. In all cases, the recommended maximum cumulative dose of 2 to 4 mg during a course of therapy was exceeded. Dose reductions are recommended in patients with renal or hepatic disease and in the elderly. All reported adverse events were associated with colchicine toxicity, including thrombocytopenia, leukopenia, pancytopenia, agranulocytosis, aplastic anemia, acute renal failure, and disseminated intravascular coagulopathy. Death occurred within 1 to 40 days after drug administration. Therapeutic guidelines exist for use of IV colchicine and these guidelines should be followed to prevent serious toxicities and death.

Revue / Journal Title

The Journal of emergency medicine   ISSN 0736-4679   CODEN JEMMDO 

Source / Source

2002, vol. 22, n^o4, pp. 385-387 (13 ref.)

Langue / Language

Anglais

Editeur / Publisher

Elsevier, New York, NY, ETATS-UNIS  (1983) (Revue)

Mots-clés anglais / English Keywords

Diseases of the osteoarticular system ; Hyperuricemia ; Metabolic diseases ; Uric acid ; Death ; Case study ; Human ; Toxicity ; Intravenous administration ; Treatment ; Chemotherapy ; Colchicine ; Gout ;

Mots-clés français / French Keywords

Système ostéoarticulaire pathologie ; Hyperuricémie ; Métabolisme pathologie ; Urique acide ; Mort ; Etude cas ; Homme ; Toxicité ; Voie intraveineuse ; Traitement ; Chimiothérapie ; Colchicine ; Goutte(pathologie) ;

Mots-clés espagnols / Spanish Keywords

Sistema osteoarticular patología ; Hiperuricemia ; Metabolismo patología ; Urico ácido ; Muerte ; Estudio caso ; Hombre ; Toxicidad ; Vía intravenosa ; Tratamiento ; Quimioterapia ; Colchicina ; Gota(patología) ;

Localisation / Location

INIST-CNRS, Cote INIST : 20201, 35400010509710.0110