Latisse Side Effects: FDA Warns Allergan over Misleading Claims

Latisse wants you to "Look who's growing longer, fuller, darker lashes." Unfortunately for Latisse and it maker Allergan, Inc., the FDA wants you to look at who may be growing unwanted non-eyelash hair, getting brown pigmentation (possibly permanent) in their irises, getting brown pigmentation on their eyelids, and possibly having allergic reactions.

Here is the warning letter sent by the FDA to Latisse maker Allergan, who brought us Botox, amongst other hit cosmetic drugs.

The FDA is concerned about the "FAQs" and "About Safety" pages on the Latisse website. It appears, that in addition to watching Brooke Shields' remarkable eyelash journey made possible by Latisse, consumers might encounter some less than forthcoming claims about risks associated with the cosmetic drug.

This is not about failure to include something in the fine print of an ad or laundry list at the end of a TV commercial, but instead about the website where consumers go to find out basic information about what risks Latisse might pose.

The FDA's problems with the Latisse site include:

• Warning users not to apply latisse to the lower lashes, but not telling them why -- because applying Latisse to the lower lashes could cause unwanted hair growth below;
• Stating that "similar" medications have caused some brown pigmentation to seep into the iris of people's eyes, when actually the same active ingredient in Latisse has caused this; and
• Misleadingly stating that eye redness and itching associated with Latisse are not allergic reactions.

The FDA has demanded that Allergan respond by September 24 and get rid of the misleading claims.

• Will Latisse Turn Brooke Shields' Blue Eyes Brown? (Pharma Marketing Blog)
• Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) (FDA)
• Eyelash-boosting drug gets FDA panel approval (MSNBC, December 2008)
• Defective Drugs (provided by Blizzard Mccarthy & Nabers)
• Injuries from Dangerous or Defective Products (provided by Law Offices of Michael P Burakoff PA)