FDA informed healthcare professionals and consumers of the seizure of 12,682 applicator tubes of Age Intervention Eyelash, sold and distributed by Jan Marini Skin Research, Inc. of San Jose, California. The product was seized because it may lead to decreased vision in some users. The eyelash product is an unapproved and misbranded drug because it is promoted to increase eyelash growth. Before a new drug product may legally be marketed, it must be shown to be safe and effective, and approved by FDA. FDA considers the product to be an adulterated cosmetic because it contains bimatoprost, an active ingredient in an FDA-approved drug to treat elevated intraocular pressure (elevated pressure inside the eye). Use of the prescription drug in addition to the eyelash product containing 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 deceased vision and possibly blindness. Other possible adverse events may include macular edema (swelling of the retina) and uveitis (inflammation in the eye) which may lead to decreased vision.

Dermatologists, estheticians, and consumers who may still have Age Intervention Eyelash should discontinue use and discard any remaining product. Consumers should also consult their healthcare professional if they have experienced any adverse events that they suspect are related to use of the product.

Read the complete 2007 MedWatch safety summary including a link to the FDA News Release regarding this issue at:

http://www.fda.gov/medwatch/safety/2007/safety07.htm#Eyelash

Here’s the precribing info….

http://www.lumigan.com/46link%20-%20PI.pdf

ed at Pharmalot