Photocure’s Metvixia gets safety labeling revision from FDA
The U.S. Food and Drug Administration has approved safety labeling revisions for Photocure’s Metvixia (methyl aminolevulinate HCl 16.8%) for use with the company’s Aktilite CL238 lamp. The site of treatment becomes photosensitive during the period between application of the cream and red-light illumination. That is why FDA has warned of adverse effects of dermal photosensitization, advising patients to avoid exposing the area to bright light. Sunscreen does not help in the protection of treated lesions. Patients should stay away from sunlight for two days after the therapy. FDA has also laid down that only trained physicians can apply the Metvixia cream.
