Latisse website failed to adequately warn readers of the risk of bacterial keratitis

The Food and Drug Administration warned Allergan, Inc., makers of the cosmetic drug Latisse, that its website for the product is misleading and suggests that the drug was safer than it really is.  In a warning letter dated September 10, 2009, the FDA said that the Latisse website failed to adequately warn readers of the risk of bacterial keratitis from contamination of Latisse or the applicators, special risks to contact lens wearers, and the risk of the risk of excess hair growth outside of the treatment area.

The FDA also warned that the website minimized some risks associated with Latisse.  For example, the website states that eye itching and redness are not allergic reactions, and do not mean that your eyes are being harmed. However, according to Latisse=s package insert, allergic conjunctivitis is an adverse reaction reported with bimatoprost ophthalmic solution, the same active ingredient that is used in Latisse.  Moreover, eye redness and itching, which are frequent symptoms of an allergic reaction, usually resolve only after discontinuation of the drug.  This is important because patients are unlikely to be able to differentiate between eye redness associated with conjunctival hyperemia, an allergic reaction, or inflammation.

Promotional materials are misleading 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 drug as recommended or suggested by the materials.  Promotional materials are also misleading if they fail to present risk information associated with the drug with a prominence and readability reasonably comparable with the claims of effectiveness related to the drug.

Latisse has only been on the market since December of 2008, but is expected to earn the company around $500 million at its peak in projected annual sales.  The Brooke Shields endorsed Latisse was discovered by Allergan scientists to make eyelashes darker, fuller and longer.  The active ingredient in Latisse is bimatoprost, a prostaglandin used to control the progression of glaucoma and in the management of ocular hypertension.  It is also the active ingredient in the glaucoma drug lumigan.

If you have suffered a serious injury to your eyes from using Latisse, we would like to hear from you.

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