According to a press release from the European Medicines Agency (EMA), its Committee for Medicinal Products for Human Use (CHMP) has completed a review of the safety of topical formulations of the NSAID ketoprofen and concluded that the benefit-risk balance of these medicines continues to be positive. 

The review was initiated after concerns over the risk of skin photosensitivity reactions, and a new risk of co-sensitisation with octocrylene (a chemical sun filter included in several cosmetic and care products) were raised.  After reviewing all of the available safety data, the CHMP concluded that the risk of serious photoallergic reactions was very low (1 case per 1 million patients treated) and that this risk could be minimised by harmonised risk-minimisation measures.

The Committee has recommended that topical ketoprofen should only be used when prescribed by a physician, and that patients should be informed on how to use these medicines appropriately to prevent the occurrence of serious skin photosensitivity reactions.  The CHMP also recommended strengthening the contra-indications and warnings on sun exposure and a warning on the risk of co-sensitisation when used together with octocrylene-containing products.

The CHMP’s recommendation has been forwarded to the European Commission for the adoption of a binding decision.