Allergan gets FDA notice on Latisse Web site

FDA says Allergan left out or minimized Latisse risks and side effects on Web site

• By Marley Seaman, AP Health Writer
• On 3:13 pm EDT, Thursday September 17, 2009

NEW YORK (AP) -- The Food and Drug Administration has informed Allergan Inc. that the Web site for its eyelash thickener Latisse is misleading because it avoids or downplays risks associated with the product.

Allergan said it is in talks with the FDA, and has made some changes to the Latisse site.

In a letter dated Sept. 10 and posted to the FDA Web site Wednesday, the agency said the Latisse site either doesn't mention potential side effects including bacterial eye infection, allergic reactions, excess hair growth outside the intended treatment area, and permanent changes in iris and eyelid pigmentation, or presents them in small text that is much less prominent than statements about the product's effectiveness.

The drug is approved to make eyelashes thicker, fuller and darker. The FDA approved it for that use in December. Latisse, or bimatoprost, was already on the market as a treatment for glaucoma.

In some cases, pages on the Web site leaves out information that is included in Latisse packaging.

"These promotional materials are misleading because they omit and minimize risks associated with Latisse," the agency wrote. Allergan was asked to immediately stop distributing the misleading material and send a written response to the FDA by Sept. 24.

In the letter, the Irvine, Calif.-based company is supposed to state whether it will comply with the FDA request, list all Latisse promotional materials, identify those that violate FDA rules, and explain its plan to stop using those materials.

Allergan said it removed from the Web site a page about the history of eyelash enhancer developments, which the FDA said did not present risk information in a prominent or readable way compared with the claims about Latisse's effectiveness, and left out important risks. The company said it is working with the FDA to address the other issues raised in the letter.

In afternoon trading, Allergan shares slid 76 cents to $57.79.

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