FDA Confirms Seizure of Eyelash Product Was Not Prompted by Reports of Adverse Effects
According to its November 16, 2007, news release, the FDA seized aneyelash product (not made by Athena Cosmetics) because the agency had concernsthat an ingredient in the product, bimatoprost, could possibly havedeleterious side effects if it were improperly used in the eye with amedication used to treat glaucoma that also contains bimatoprost. As affirmedby Mr. Swezey in a November 19th WSJ article, the FDA did not seize theeyelash product because the FDA or the company that made the product hadreceived reports of any of the serious side effects listed in the FDA's newsrelease.
The FDA's action has created some public concern about the safety ofsimilar eyelash products sold by Athena Cosmetics, Inc. and other companies.Athena Cosmetics wants to assure its customers that, as confirmed by the FDAfor the product it seized, there have been no reports of patient injuries orsignificant adverse effects from thousands of satisfied RevitaLash(R)customers. To the contrary, only a very small number of RevitaLash(R)consumers have reported minor, temporary side effects such as irritation orredness. In addition, the safety of RevitaLash(R) has been tested in twoclinical tests conducted by a reputable research laboratory. No adversereactions were observed in either clinical study of RevitaLash(R).
RevitaLash(R) was developed by an ophthalmologist, Dr. MichaelBrinkenhoff, the founder of Athena Cosmetics. As a practicing physician, Dr.Brinkenhoff formulated RevitaLash(R) with safety as the highest priority.Thousands of happy and satisfied customers have safely used RevitaLash(R) toenhance the beauty of their eyelashes. While Athena Cosmetics is confidentthat RevitaLash(R) is safe, because of possible public concern overbimatoprost created by the FDA's news release, we have decided to stop sellingthe current formulation of RevitaLash(R). Fortunately, we had been developingnew formulations as part of our ongoing commitment to product excellence andcustomer satisfaction. To minimize disruption to our loyal customers we willaccelerate the launch of our reformulated RevitaLash(R) and are now targetinga mid-December launch. We are excited about our new and improvedRevitaLash(R) and remain committed to giving our customers the best -- andsafest -- product possible.
SOURCE Athena Cosmetics, Inc.
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