France. The French Agency for the Medical Safety of Health Products, AFSSAPS, has noted an increase in the number of reports of severe adverse events in association with fluorescein (AK-Fluor), in particular, allergic reactions. By October 2004, the agency had received 23 such cases, five of which had a fatal outcome. As a precaution, AFSSAPS recommends that prescribers avoid fluorescein angiography in conditions/diseases where there is no benefit from the procedure. AFSSAPS reminds prescribers to take a detailed history and to monitor patients closely during, and for 30 minutes after, the procedure. A letter has been sent to relevant health-care professionals regarding this information.
Choulika S. Recommendations regarding the use of fluorescein injection. Vigilances, February 2005, 3(25).