Following a review of topical formulations of Ketoprofen, the European Medicines Agency’s Committee for Medicinal Products for Human Use ( CHMP ) has concluded that the benefit-risk balance of these medicines continues to be positive. However, the Committee recommended that physicians should inform patients on how to use these medicines appropriately to prevent the occurrence of serious skin photosensitivity reactions.

Ketoprofen is a non-steroidal anti-inflammatory drug ( NSAID ). Topical formulations of Ketoprofen are used to treat minor trauma, tendonitis, small-joint osteoarthritis, acute low-back pain and phlebitis.

The review of these medicines had been initiated further to concerns over the risk of skin photosensitivity reactions, including photoallergy, and a new risk of co-sensitisation with Octocrylene ( a chemical sun filter included in several cosmetic and care products ).

Having reviewed all available safety data, including data from EU member states’ databases and data provided by involved manufacturers, the CHMP has 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. The CHMP has also recommended strengthening the contraindications and warnings on sun exposure and a warning on the risk of co-sensitisation when used together with Octocrylene-containing products.

Source: EMA, 2010


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