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. 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.