title: Outcomes and safety of drug provocation tests.
abstract: Drug provocation tests (DPTs) are considered the gold standard for identifying adverse drug reactions (ADRs). The aim of this study was to analyze DPT results and discuss severe systemic reactions associated with them. This was a retrospective analysis of 500 patients with ADRs who sought treatment and were submitted to DPTs when indicated between 2006 and 2010. We performed DPTs according to the European Network for Drug Allergy recommendations. Single-blind, placebo-controlled DPTs were performed with antibiotics, local anesthetics, and nonsteroidal anti-inflammatory drugs, as well as with other drugs. Patient characteristics, DPT results, and reactions were analyzed. The sample comprised 198 patients (80.8% of whom were female patients) submitted to 243 DPTs. Ages ranged from 9 to 84 years (mean, 39.9 years). The 243 DPTs were performed with local anesthetics (n = 93), antibiotics (n = 19), acetaminophen (n = 44), benzydamine (n = 33), COX-2 inhibitors (n = 26), dipyrone (n = 7), aspirin (n = 4), or other drugs (n = 17). The results of 4 tests (1.6%) were inconclusive, whereas those of 10 (4.1%) revealed positive reactions to antibiotics (2/19), COX-2 inhibitors (2/26), acetaminophen (3/44), and local anesthetics (3/93). Two severe reactions were observed: cephalexin-induced anaphylactic shock and bupivacaine-induced anaphylaxis without shock. Four patients (2.0%) reacted to the placebo before administration of the drug. Drug provocation tests are safe for use in clinical practice but they should be placebo-controlled and should be performed under the supervision of an allergist. To confirm a presumptive diagnosis and to manage allergies appropriately, it is crucial to perform DPTs.
authors.affiliation: Department of Clinical Immunology and Allergy, São Paulo University, Brazil.
authors.forename: Marcelo Vivolo
authors.initials: MV
authors.lastname: Aun
authors.forename: Carla
authors.initials: C
authors.lastname: Bisaccioni
authors.forename: Laila Sabino
authors.initials: LS
authors.lastname: Garro
authors.forename: Adriana Teixeira
authors.initials: AT
authors.lastname: Rodrigues
authors.forename: Luciana Kase
authors.initials: LK
authors.lastname: Tanno
authors.forename: Luis Felipe Chiaverini
authors.initials: LF
authors.lastname: Ensina
authors.forename: Jorge
authors.initials: J
authors.lastname: Kalil
authors.forename: Antônio Abílio
authors.initials: AA
authors.lastname: Motta
authors.forename: Pedro
authors.initials: P
authors.lastname: Giavina-Bianchi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000707:Anaphylaxis / Q000453:epidemiology; D000779:Anesthetics, Local / Q000008:administration & dosage / Q000009:adverse effects; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects; D002648:Child; D004342:Drug Hypersensitivity / Q000175:diagnosis*; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D006969:Hypersensitivity, Immediate / Q000139:chemically induced / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D004364:Pharmaceutical Preparations / Q000008:administration & dosage; D012189:Retrospective Studies; D016037:Single-Blind Method; D012882:Skin Tests / Q000379:methods; D055815:Young Adult
chemical_list: D000779:Anesthetics, Local; D000900:Anti-Bacterial Agents; D000894:Anti-Inflammatory Agents, Non-Steroidal; D004364:Pharmaceutical Preparations