Spontaneous reporting of serious cutaneous reactions with protein kinase inhibitors.
Purpose: Our aim was to describe all serious cutaneous adverse drug reactions (ADRs) spontaneously reported in France for all oral protein kinase inhibitors, their characteristics and whether they were labeled (reported in the Summary of Product Characteristics) or not. Methods: We performed a retro...
| Publicado en: | European Journal of Clinical Pharmacology Vol. 69; no. 10; pp. 1819 - 1827 |
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| Autores principales: | , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Springer Nature
Oct2013
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=104226242&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 104226242 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00316970 NP9 jtl: European Journal of Clinical Pharmacology issn: 00316970 maglogo: N pubinfo: dt: Oct2013 vid: 69 iid: 10 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 104226242 90245854 10.1007/s00228-013-1532-6 NLM23748749 104226242 ppf: 1819 ppct: 8 formats: fmt: @attributes: type: P tig: atl: Spontaneous reporting of serious cutaneous reactions with protein kinase inhibitors. aug: au: Faye, Emmanuelle Bondon-Guitton, Emmanuelle Olivier-Abbal, Pascale Montastruc, Jean-Louis sug: subj: Protein Kinases Antagonists and Inhibitors Skin Manifestations Adverse Drug Event Human Retrospective Design Observational Methods Pharmacovigilance Male Female Middle Age Aged Adolescence Aged, 80 and Over Descriptive Statistics Data Analysis Software Hypersensitivity, Delayed Sex Factors Middle Aged: 45-64 years Aged: 65+ years Adolescent: 13-18 years Aged, 80 & over Male Female ab: Purpose: Our aim was to describe all serious cutaneous adverse drug reactions (ADRs) spontaneously reported in France for all oral protein kinase inhibitors, their characteristics and whether they were labeled (reported in the Summary of Product Characteristics) or not. Methods: We performed a retrospective observational study in the French PharmacoVigilance Database, selecting for analysis serious cutaneous reactions of patients due to treatment with oral protein kinase inhibitors (erlotinib, gefitinib, imatinib, nilotinib, dasatinib, sunitinib, sorafenib, pazopanib, lapatinib, everolimus) between 1 January 2008 and 31 December 31 2010. Results: Ninety-four patients suffered from 115 serious cutaneous reactions due to oral protein kinase inhibitors. Serious cutaneous reactions more frequently reported were maculo-papular rash (mostly with imatinib), followed by hand-foot syndrome (specifically with sorafenib) and papulopustular rash (particularly with erlotinib). Patients were mostly males (63 %) with a mean age of 62.6 ± 15.4 years. Drug withdrawal was observed in 73.1 % of cases because of these cutaneous reactions. Delay of occurrence of the ADR varied from 11.5 to 58.5 days. Unlabeled serious reactions were found (17.4 %), including skin ulceration, vasculitis or purpura with sorafenib or sunitinib and drug rash with eosinophilia and systemic symptoms with imatinib. Conclusion: Some of the serious ADRs spontaneously reported with oral protein kinase inhibitors are labeled and commonly reported in the literature, but others occur only rarely and unlabeled. In our study, most serious ADRs occurred in males within the 2 first months of treatment and were responsible for the withdrawal of therapy with protein kinase inhibitors. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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