Pharmaceutical specialties containing ketoprofen
Ketoprofen-containing proprietary medicinal products are approved for the local symptomatic therapy of pain conditions, mainly in the field of traumatology and rheumatology.
Due to reports of light-allergic reactions, the risk-benefit balance of these proprietary medicinal products was evaluated on a pan-European level under an Article 107 procedure. The associated binding decision of the European Commission is available, and the measures adopted are currently being implemented.
Measures at EU level
An increasing number of reports of skin reactions, some of them serious, including photoallergic and phototoxic reactions in France, led to the initiation of an Article 107 procedure. The reactions mentioned occurred, among other things, during simultaneous use with octocrylene, which is contained as a stabilizer in many cosmetics and as a UV filter in sunscreens.
The Committee for Medicinal Products for Human Use (CHMP) conducted a comprehensive evaluation of the risk-benefit balance of ketoprofen-containing medicinal products for topical use, including all available non-clinical, clinical, pharmacoepidemiological and post-marketing data.
The CHMP concluded that the overall benefit of topical use of ketoprofen outweighs the risk associated with its use. Furthermore, the study conducted showed that the frequency of occurrence of photoallergic reactions is comparatively low (approximately one case per million applications) and that the risk of this can be minimized by taking appropriate measures.
In this context, in addition to the inclusion of additional warnings in the technical information and directions for use, it was decided to make ketoprofen-containing medicinal products for topical use subject to prescription throughout Europe.
Situation in Austria
In Austria, the following ketoprofen-containing medicinal specialties for topical use are approved:
- Fastum Gel
- Ketoprofen 10% spray
BASG has not received any reports of adverse reactions to these medicinal specialties.
Recommendations of the BASG
- Prescribers are advised to carefully observe the contraindications of the currently valid technical information when prescribing.
- When prescribing and dispensing medicinal products containing ketoprofen, patients should be advised of the importance of preventive measures to avoid photosensitivity reactions.
- Patients are strongly advised to follow the current directions for use of the affected preparations and the following directions for use:
- The treated skin areas must not be exposed to direct sunlight (even on cloudy days), or UV light (e.g., tanning salon) during treatment and for two weeks after cessation/ discontinuation.
- Suitable clothing should be worn to protect the treated areas of the body from sunlight.
- The simultaneous use of octocrylene can potentially increase the adverse reactions and should therefore be avoided. This substance is contained in many cosmetics, including sunscreens.
- Do not use an occlusive dressing (causes tight wound closure) after local application of ketoprofen.
- Wash hands thoroughly after each application.
- In case of occurrence of any skin reaction after application of any of the preparations, the treatment should be discontinued immediately. It is advisable to seek medical help in such cases.
