The aim of this study was to assess the prevalence of exposure to topical nonsteroidal anti-inflammatory drugs (NSAIDs), particularly ketoprofen, in a convenience sample of the population, to obtain estimates of the incidence of severe photosensitivity leading to hospitalization, and to assess causative factors in three catchment areas: the Paris metropolitan area, the Lombardy region (Italy) and the Prague area. All cases of severe photosensitivity not explained by underlying conditions and admitted to hospitals in the selected areas were included in the study. Controls were patients consecutively admitted to hospitals, in the same areas, for an acute condition or for an elective procedure not suspected of being related to medication use. From October 2012 to September 2013, 920 controls were recruited (median age 44 years, 50.8% females); 8 severe photosensitivity cases were reported in the population aged 18-74 years of the 3 geographical areas during the 1-year surveillance period, corresponding to an incidence rate of 4.81 cases per 10 million person-years (95% confidence interval - CI, 2.07-9.48). Six controls reported 1-month exposure to topical ketoprofen, with an estimated prevalence of 0.65% (95% CI, 0.24-1.42). The population attributable risk for severe photosensitivity reactions linked to ketoprofen was 11.92% (95% CI, -0.12-52.99). This study was conducted in selected European areas and showed that the incidence of severe photosensitivity reactions leading to hospitalization as well as the exposure rate to topical ketoprofen were low. Among topical NSAIDs, topical ketoprofen was the leading cause of photosensitivity reactions but accounted for a limited number of hospitalized cases. Probably most of the relevant reactions were managed in the outpatient setting and a community based case-control study is advisable.

Department of Dermatology 2nd Faculty Charles University and Hospital Bulovka Budínova 2 CZ 180 81 Prague Czech Republic

Department of Dermatology Hôpital Henri Mondor 51 avenue du Maréchal de Lattre de Tassigny 94010 Créteil France; UPEC Université and EA EpiDermE Paris Est Créteil Val de Marne 8 Rue du Général Sarrail 94000 Créteil France; French satellite of the Cochrane Skin Group Hôpital Henri Mondor 51 avenue du Maréchal de Lattre de Tassigny 94010 Créteil France; INSERM Centre d'Investigation Clinique 143051 avenue du Maréchal de Lattre de Tassigny 94010 Créteil France

Department of Global Pharmacovigilance and Epidemiology R and D Sanofi 1 Avenue Pierre Brossolette 91385 Chilly Mazarin France

FROM Presidio Ospedaliero Matteo Rota Via Garibaldi 13 15 24122 Bergamo Italy

FROM Presidio Ospedaliero Matteo Rota Via Garibaldi 13 15 24122 Bergamo Italy; Department of Dermatology Azienda Ospedaliera papa Giovanni XXIII Piazza OMS 124127 Bergamo Italy

FROM Presidio Ospedaliero Matteo Rota Via Garibaldi 13 15 24122 BergamoItaly; Department of Dermatology Inselspital University Hospital Freiburgstrasse 323010 Bern Switzerland

Menarini Ricerche S p A Via Sette Santi 3 50131 Florence Italy

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