The Food and Drug Administration has issued a warning to Allergan Inc., the makers of the eye lash thickener Latisse, claiming that the Latisse website downplays the risks associated with the product.
In a letter dated September 10 the FDA said that the Latisse site did not display adequate warnings about potential side effects associated with Latisse. According to the letter the website either failed to mention or displayed potential side effects in small text that does not attract the same attention as the text highlighting the product’s efficacy.
Potential side effects of Latisse include bacterial eye infection, allergic reactions, excess hair growth outside intended treatment area, and permanent changes in eyelid and iris pigmentation.
Latisse was approved last December by the FDA to make eyelashes fuller, thicker, and darker.
The FDA ordered Allergan to immediately discontinue distribution of “misleading” marketing materials and send an written response to the FDA by the September 24.