To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Notice of Potentially Harmful "Cosmetic" Eye Product URL: http://www.pslgroup.com/dg/217872.htm Doctor's Guide November 19, 2007
WASHINGTON, DC -- November 19, 2007 -- The U.S. Food and Drug Administration (FDA) informed healthcare professionals and consumers of the seizure of 12,682 applicator tubes of Age Intervention Eyelash, a product that may, in some users, lead to decreased vision. Age Intervention Eyelash is sold and distributed by Jan Marini Skin Research, Inc., of San Jose, Calif. The FDA considers Age Intervention Eyelash to be an unapproved and misbranded drug because Jan Marini Skin Research has promoted the product to increase eyelash growth. The FDA also considers the seized Age Intervention Eyelash to be an adulterated cosmetic. The product contains bimatoprost, an active ingredient in an FDA-approved drug to treat elevated intraocular pressure. For patients using the prescription drug, using the Age Intervention Eyelash in addition to the drug may increase the risk of optic nerve damage because the extra dose of bimatoprost may decrease the prescription drug's effectiveness. Damage to the optic nerve may lead to decreased vision and possibly blindness. In addition, use of Age Intervention Eyelash may cause other adverse effects in certain people due to the bimatoprost, including macular edema and uveitis, which may lead to decreased vision. The U.S. Attorney's Office for the Northern District of California filed the complaint requesting the seizure, and coordinated with the FDA. The California Department of Public Health's Food and Drug Branch had previously embargoed the seized products at the San Jose facility. Jan Marini Skin Research has notified the FDA that the company ceased manufacturing and shipping any Age Intervention Eyelash product containing bimatoprost last year. The FDA recommends that consumers, dermatologists, and estheticians who may still have Age Intervention Eyelash discontinue using it and discard any remaining product. FDA also recommends that consumers consult their healthcare provider if they have experienced any adverse events that they suspect are related to the product's use. SOURCE: U.S. Food and Drug Administration --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.