Allergan Gets Warning Letter on Latisse for Omitting Infection Risk

Last Updated Sep 17, 2009 10:45 AM EDT

Allergan has already caught its first warning letter from the FDA for downplaying the risks of Latisse, its new eyelash lengthener, less than a year into its launch.

The warning adds another rule to the art director's rulebook: In wall displays, don't put the advantages of the drug in large type and the side effects on a small card near the bottom -- the FDA wants them equal-sized. Referring to a wall display of the type that might be seen in a mall or at a conference, the FDA said:

... the only risk information that is presented for Latisse is included on a small placard to the lower right of the timeline exhibit. As such, this display fails to present risk information with a prominence and readability reasonably comparable with the presentation of information relating to the effectiveness of the drug.
A version of that timeline, as yet unaltered, is currently on Latisse's web site (click to enlarge image above), and you can download photos of it from the FDA here. And, of course, referring people to a web site instead of actually providing the side effect information remains a no-no.

More seriously, Allergan's Latisse web site didn't even list all the risks, the FDA said:

... the webpages omit important risks associated with Latisse, including the risk of bacterial keratitis from contamination of Latisse or the applicators, and the risk of use with contact lenses.
You can see that page for yourself here. Here's a screengrab of what it looked like before the FDA cited it: