Clinical profile of oxcarbazepine-related angioneurotic edema: case report and review.
Oxcarbazepine, a carbamazepine analog, was approved for use as an antiepileptic agent in the United States in 2000. A search of the United States Food and Drug Administration's Adverse Event Reporting System identified nine cases of oxcarbazepine-associated angioedema in pediatric patients aged 16 years and younger. We describe in detail the first U.S. case report, of a 4(1/2)-year-old boy who experienced angioedema during treatment with oxcarbazepine. The reporting rate for angioedema was calculated to be 9.8 cases per 1,000,000 pediatric patients. Oxcarbazepine-associated angioedema manifested by swelling of the face, eyes, lips, or tongue or difficulty swallowing or breathing (or both) is a rare but potentially life-threatening reaction for which early recognition and management are vital.
Office of Drug Evaluation I, Division of Neurology Products, Food and Drug Administration, Silver Spring, Maryland 20993-0002, USA. james.knudsen@fda.hhs.gov
James F
JF
Knudsen
Charlene M
CM
Flowers
Cindy
C
Kortepeter
Yasser
Y
Awaad
D000799:Angioedema / Q000139:chemically induced*; D000927:Anticonvulsants / Q000009:adverse effects*; D002220:Carbamazepine / Q000009:adverse effects / Q000031:analogs & derivatives*; D002675:Child, Preschool; D004827:Epilepsy / Q000188:drug therapy*; D006801:Humans; D008297:Male; D000078330:Oxcarbazepine; D014481:United States
D000927:Anticonvulsants; D002220:Carbamazepine; D000078330:Oxcarbazepine