Maybe you haven’t come to recognize the name right away, but if you’ve seen Brooke Shields fluttering her eyelashes in print and broadcast ads recently, you’ve caught a glimpse of a new product: Latisse®. Created by Allergan, the same people who brought the incredibly popular BOTOX® Cosmetic to market, Latisse lengthens, darkens and thickens eyelashes, according to its famous spokesmodel.
The Food and Drug Administration approved Latisse for use as an eyelash booster just a year ago. You’re not alone, then, if you have questions about the product. Is it safe? Does it work? Is it worth the cost?
From my point of view, the early days after the FDA gives thumbs up to a new product can be tricky. No matter how many clinical trials a product has gone through, some cause unwanted effects that show up after widespread adoption by the public and/or following years of use. Just as with other “breakthrough” products, it’s a good idea to do some research and err on the side of caution before you decide to take the plunge.
Even if you’re familiar with Latisse, you may not know that the FDA originally approved it in 2001 as a treatment for glaucoma. As attorneyatlaw.com, a legal information site for the general public, explains, “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.”
Just two weeks ago, however, the FDA sent a letter of reprimand to Allergan, finding that the company’s promotional materials, “omit and minimize risks associated with Latisse.” The letter, from a regulatory review officer with the FDA, found the company deficient in covering risks such as: increased brown pigmentation in the iris, discoloration of skin around the eyes, hair growth outside the areas of treatment, inflammation and infection and the potential for absorption by contact lenses.