23 July 2010
The Department of Health (DH) today (July 23) drew public attention to the risk of serious skin sensitive and allergic reactions in patients using topical products containing ketoprofen.
The DH, through its drug surveillance network, noted that the European Medicines Agency advised healthcare professionals of the potential risk on July 22 (EU time) and recommended that the risk be shown on the product labels.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) reviewed all available safety data and concluded that there was a risk of serious skin sensitive and allergic reactions to sunlight but the risk was very low (one case per one million patients treated). Sensitive skin reactions were also noted in people using topical ketoprofen together with products containing octocrylene (a chemical sun filter included in several cosmetic and care products). The CHMP recommended that strengthened warnings on sun exposure and the risk of sensitive skin reactions when topical ketoprofen is used together with octocrylene.
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.
In Hong Kong, there are twenty-three registered topical products containing ketoprofen. They can only be sold on a doctor's prescription in pharmacy under the supervision of a pharmacist.
The finding has already been referred to the Registration Committee of the Pharmacy and Poisons Board for review in its next meeting.
Healthcare professionals and patients should be aware of the risk of skin allergic reactions to sunlight with the use of topical ketoprofen. Healthcare professionals should tell their patients how to use topical ketoprofen appropriately.
Patients using topical ketoprofen should make sure that the treated areas are protected from sunlight during the whole period of ketoprofen treatment and the two weeks after discontinuation of the treatment. They should stop treatment immediately if they develop any skin reaction after application of these medicines and consult their healthcare professionals.