Web Site for Eyelash-Thickening Drug Latisse is Misleading, FDA Warns

The web site for the cosmetic drug Latisse is misleading and gives consumers the impression that the eyelash-thickening drug made by the same company behind the blockbuster cosmetic drug Botox is safer than it really is, the Food and Drug Administration said.

Allergan Inc., the Orange County, Ca.-based manufacturer of Latisse and Botox Cosmetic, was sent a warning letter from the FDA last week. In the letter, the FDA says the company’s web site for Latisse leaves out important information about the risks of developing bacterial keratitis, an eye disease that can lead to blindness.

Also, the web site and other promotional materials do not mention that Latisse may cause hair to grow in other areas of the body if the drug comes into contact with the skin. In short, the FDA thinks Allergan is promoting Latisse as being safer than it has been shown to be by omitting the risks from the materials.

The FDA is asking Allergan to correct the misleading web site and other promotional materials to include the risks, but the company has until Sept. 24 to either do as the FDA asks or tell the agency why the changes to the web site are not necessary.

Latisse Grew From Glaucoma Drug’s Side Effect

Latisse came about sort of by accident. Allergan researchers discovered that bimatoprost, the active ingredient in its glaucoma drug called Lumigan, had the side effect of making eyelashes darker, fuller, and longer. The company then asked the FDA to approve the drug as a cosmetic treatment, to be called Latisse, and the agency granted the new use of the drug in late 2008. An advisory panel to the FDA recommended the new approval after reviewing clinical study data provided by Allergan.

The drug is a liquid that dropped daily directly onto eyelashes. At the time the drug was approved for the new cosmetic use, Allergan said Latisse might turn out to be a big-seller capable of earning the company about $500 million in annual sales. Television ads for Latisse feature actress Brooke Shields, who is described as a user and a spokesperson for the product.

Strong Sales for Latisse, So Far

So far, Latisse has proven to be a solid revenue generator for Allergan, on pace to earn $60 million in 2009 and on track to top out at the $500 million mark at its sales peak.

According to a report in the Orange County Business Journal, Allergan is working closely with the FDA to address the concerns about the misleading promotional materials. Also, the company says it has stopped using an exhibit that described the evolution of eyelash enhancers, which drew objections from the FDA.

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