Centro Studi GISED

Ketoprofen is a non steroidal anti-inflammatory drug (NSAID), with analgesic and antipyretic effects, whose use can be associated with severe photosensitivity reactions which can lead to hospitalization. The incidence of such reactions in patients using the drug is currently unknown.

Many reports on adverse events have prompted EMA to request a study, which aims at evaluating the incidence rate of severe photosensitivity reactions, and at assessing the risks related to the use of topical ketoprofen and other NSAIDs. The study was implemented as a pilot phase in order to determine the feasibility of a subsequent wider study.

This pilot phase was coordinated by Centro Studi Gised and involved centers located in three geographical areas representative of all Europe for exposure and incidence rates: the Lombardy region, the metropolitan area of Paris and the metropolitan area of Prague.


Results

This study, conducted in selected European areas, 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.

The results of the study were published here:

Cazzaniga S, Naldi L, Lecchi S, et al. A pilot study on the incidence of severe photosensitivity reactions leading to hospitalization linked to topical ketoprofen and other medications in selected European regions. Pharmacol Res Perspect. 2016;4:e00225.

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