American consumers are being warned by the Food and Drug Administration (FDA) about the dangers of a product which promises to increase eyelash growth.
The product, Age Intervention Eyelash, has been found to contain Bimatoprost, a drug approved by the FDA to treat elevated intraocular pressure (elevated pressure inside the eye).
The FDA says the product is an unapproved and a misbranded drug and in some users, can lead to decreased vision; the company had promoted the product to increase eyelash growth.
Age Intervention Eyelash is sold and distributed by Jan Marini Skin Research, Inc., of San Jose, California and U.S. Marshals have already seized 12,682 applicator tubes of the product with a sales value of approximately $2 million.
Any new drug product must be shown to be safe and effective, and approved by the FDA before it can be legally marketed and the FDA says Age Intervention Eyelash is an adulterated cosmetic.
Any patients using the prescription drug for it's intended purpose may increase the risk of optic nerve damage because the extra dose of Bimatoprost may decrease the prescription drug's effectiveness and lead to damage to the optic nerve resulting in decreased vision and possibly blindness.
The FDA also says the 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 also lead to decreased vision.
It was the the U.S. Attorney's office for the Northern District of California which first filed a complaint and then in a coordinated effort with the FDA seized the products from the company's San Jose facility.
The company says it ceased manufacturing and shipping any Age Intervention Eyelash product containing Bimatoprost last year.
Apparently new products produced by the company such as Age Intervention Eyelash Conditioner, do not contain the chemical and has different labeling.
The FDA has advised consumers, dermatologists, and estheticians who may still have Age Intervention Eyelash to discontinue using it and discard any remaining products.
The 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.