Biases associated with epidermal necrolysis reporting in pharmacovigilance: An exploratory analysis using World Health Organization VigiBase.

Bettuzzi, Thomas; Ingen-Housz-Oro, Saskia; Maison, Patrick; de Prost, Nicolas; Wolkenstein, Pierre; Lebrun-Vignes, Bénédicte; Sbidian, Emilie

Bettuzzi, Thomas; Ingen-Housz-Oro, Saskia; Maison, Patrick; de Prost, Nicolas; Wolkenstein, Pierre; Lebrun-Vignes, Bénédicte; Sbidian, Emilie.

Affiliation

Bettuzzi T; Service de Dermatologie, AP-HP, Hôpital Henri Mondor, Créteil, France.
Ingen-Housz-Oro S; EpiDermE, Univ Paris Est Créteil, Créteil, France.
Maison P; Service de Dermatologie, AP-HP, Hôpital Henri Mondor, Créteil, France.
de Prost N; EpiDermE, Univ Paris Est Créteil, Créteil, France.
Wolkenstein P; Centre de Référence des Dermatoses Bulleuses Toxiques et Toxidermies Graves TOXIBUL, Hôpital Henri Mondor, Créteil, France.
Lebrun-Vignes B; EpiDermE, Univ Paris Est Créteil, Créteil, France.
Sbidian E; Direction Générale, ANSM, Saint-Denis, France.

Pharmacoepidemiol Drug Saf ; 31(4): 434-441, 2022 04.

Article in En | MEDLINE | ID: mdl-34907614

Subject(s)

Pharmacovigilance; Stevens-Johnson Syndrome; Adverse Drug Reaction Reporting Systems; Anticonvulsants; Bias; Humans; Stevens-Johnson Syndrome/epidemiology; Stevens-Johnson Syndrome/etiology; World Health Organization

Key words

Stevens-Johnson syndrome; biases; classification bias; epidermal necrolysis; pharmacovigilance; protopathic bias; toxic epidermal necrolysis

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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Stevens-Johnson Syndrome / Pharmacovigilance Type of study: Etiology_studies / Prognostic_studies / Risk_factors_studies Limits: Humans Language: En Journal: Pharmacoepidemiol Drug Saf Journal subject: EPIDEMIOLOGIA / TERAPIA POR MEDICAMENTOS Year: 2022 Type: Article Affiliation country: France

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