HSA would like to remind healthcare professionals of the risk of photosensitivity reactions associated with topical ketoprofen.
Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties. Topical ketoprofen-containing products have been available in Singapore since 1992, and were re-classified to Pharmacy Only (P) medicines in 1997. They are indicated for treating signs and symptoms caused by conditions such as rheumatoid arthritis, tendinitis, muscular pain, and pain and swelling resulting from minor trauma.
Review by European Medicines Agency (EMA)
In July 2010, the EMA completed a review of the safety and effectiveness of topical ketoprofen-containing products.1 The review had been initiated due to concerns over the risk of skin photosensitivity reactions, including photoallergy as well as new skin reactions reported in people using topical ketoprofen together with products containing octocrylene (a chemical sunscreen found in several cosmetics and care products such as shampoo, skin creams, anti-ageing creams, make-up removers and hair sprays). These concerns were initially raised by the French medicines regulatory agency (Afssaps), which decided to suspend the marketing authorisation of all topical medicines containing ketoprofen in France in December 2009.
Having reviewed all available safety data, including data from EU member states' databases and data provided by the manufacturers, the EMA's Committee for Medicinal Products for Human Use (CHMP) concluded that the risk of serious photoallergic reactions was very low (one case per one million patients treated) and that the benefits of topical ketoprofen-containing products continue to outweigh their risks. However, the CHMP recommended that doctors should inform patients on how to use these medicines appropriately to prevent the occurrence of serious skin photosensitivity reactions.2
Local situation and HSA's advisory
Between 1993 and 2010, HSA received 45 reports of adverse drug reactions associated with the use of topical ketoprofen-containing products, of which 25 involved skin reactions such as dermatitis, rash, urticaria, and skin blistering. The majority (77%) of these skin reactions were assessed to be non-serious. No information was available as to whether these skin reactions were a result of photosensitivity reactions to these products.
Healthcare professionals are reminded to inform patients on how to use these products appropriately so as to prevent the occurrence of serious skin photosensitivity reactions. Advice to patients should include:
- To ensure that treated areas are protected from sunlight during the whole period of topical ketoprofen treatment and for 2 weeks after stopping treatment
- To stop treatment immediately if they develop any skin reaction after application of these medicines and seek their doctor's advice
Healthcare professionals are also strongly encouraged to report any adverse reactions suspected to be associated with topical ketoprofen-containing products to the Vigilance Branch of HSA.
References
- http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2010/07/WC500094975.pdf
- http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Ketaprofen_107/WC500094971.pdf