This suspension of marketing will take effect from January 12, and will be accompanied by a withdrawal of the available lots. 371 cases of adverse effects, 62% of which were serious, were indeed reported between January 2001 and February 2009 in patients treated with a gel containing ketoprofen. In the vast majority of cases, these reactions appear in the form of eczema and bubbles which may extend beyond the area of application.
This gel is applied to the skin, and it is used in rheumatology and benign trauma, for its ability to treat pain. Severity can lead to hospitalizations and work stoppages. Of the serious adverse reactions, 44% were photoallergy reactions, following sun exposure.
Afssaps therefore asks prescribers to no longer recommend treatment with ketoprofen gel, and to patients to stop any current treatment.
22 specialties containing ketoprofen gel have been authorized so far in France.
