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FDA Warns About Eyelash Enhancer Claims

Posted by Jane Akre
Thursday, September 17, 2009 11:49 AM EST
Category: Major Medical
Tags: Latisse, Allergan Inc., FDA, Warning Letter

Latisse maker Allergan Inc. receives a warning letter from the FDA that it is understating and overstating the product's merits.


IMAGE SOURCE: Wikimedia Commons/ thick eyelashes/ author: Chameleon

The Food and Drug Administration (FDA) Thursday warned Allergan Inc., maker of eyelash thickener, Latisse that it is misleading the public because it downplays the risks associated with the product.

Latisse was approved by the FDA last December to enhance, thicken, and darken pale eyelashes.

The concern is that Latisse ads don't mention potential bacterial eye infections and allergic reactions, as well as excess hair growth that can occur outside of the lash area, and a darkening of the eye lid.

Ads for the product do warn that it can turn the pigment portion of the eye, the iris from light to dark.

“Promotional materials are misleading it [sic] if they fail to reveal material facts in light of the representations made by the materials or with respect to consequences that may result from the use of the drugs recommended or suggested by the materials,” the FDA letter says.

Latisse (bimatoprost ophthalmic solution), approved for hypotrichosis, contains the active ingredient of the glaucoma drug Lumigan – both of which are made by Allergan.

The warning letter sent to Allergen is posted on the FDA Web site.

It tells the Irvine, California-based company to stop distributing misleading materials that in some cases, omits information on the Latisse warning label, or overstates claims of efficacy. Allergan was asked to immediately stop distributing the misleading material and to send a response to the FDA by September 24 as to whether it plans to comply with the FDA request.

Allergan reports that Latisse sales brought $60 million to the company in 2009. Allergan is also the company that makes Botox Cosmetic.

The FDA does not have the power to order companies into compliance or to recall a drug, but the agency says the companies usually comply with an FDA request. #

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