Potentially Harmful "Cosmetic" Eye Product Seized
At FDA's request, U.S. Marshals have seized 12,682 applicator tubes of Age Intervention Eyelash, a product that may lead to decreased vision in some users. Authorities said the sales value of the seized tubes is approximately $2 million. Age Intervention Eyelash is sold and distributed by Jan Marini Skin Research, Inc., of San Jose, Calif.
- 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. Before a new drug product may be legally marketed, it must be shown to be safe and effective, and approved by FDA.
- 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 (elevated pressure inside the eye). For patients using the prescription drug, also using the Age Intervention Eyelash in addition 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 (swelling of the retina) and uveitis (inflammation in the eye), which may lead to decreased vision.
Jan Marini Skin Research has notified FDA that the company ceased manufacturing and shipping last year any Age Intervention Eyelash product containing bimatoprost.
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 health care provider if they have experienced any adverse events that they suspect are related to the product's use.
Date Posted: November 19, 2007
