HENDERSON, Nev., Nov. 20 /PRNewswire/ -- FDA spokesman, Brad Swezey, affirmed to the Wall Street Journal (WSJ) yesterday that the FDA had not received any reports of patient injuries or adverse effects related to use of the eyelash product the agency seized last Friday.
According to its November 16, 2007, news release, the FDA seized an eyelash product (not made by Athena Cosmetics) because the agency had concerns that an ingredient in the product, bimatoprost, could possibly have deleterious side effects if it were improperly used in the eye with a medication used to treat glaucoma that also contains bimatoprost. As affirmed by Mr. Swezey in a November 19th WSJ article, the FDA did not seize the eyelash product because the FDA or the company that made the product had received reports of any of the serious side effects listed in the FDA's news release.
The FDA's action has created some public concern about the safety of similar eyelash products sold by Athena Cosmetics, Inc. and other companies. Athena Cosmetics wants to assure its customers that, as confirmed by the FDA for the product it seized, there have been no reports of patient injuries or significant 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 or redness. In addition, the safety of RevitaLash(R) has been tested in two clinical tests conducted by a reputable research laboratory. No adverse reactions were observed in either clinical study of RevitaLash(R).
RevitaLash(R) was developed by an ophthalmologist, Dr. Michael Brinkenhoff, 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) to enhance the beauty of their eyelashes. While Athena Cosmetics is confident that RevitaLash(R) is safe, because of possible public concern over bimatoprost created by the FDA's news release, we have decided to stop selling the current formulation of RevitaLash(R). Fortunately, we had been developing new formulations as part of our ongoing commitment to product excellence and customer satisfaction. To minimize disruption to our loyal customers we will accelerate the launch of our reformulated RevitaLash(R) and are now targeting a mid-December launch. We are excited about our new and improved RevitaLash(R) and remain committed to giving our customers the best -- and safest -- product possible.
|SOURCE Athena Cosmetics, Inc.|
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