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FDA seizes eyelash growth product containing bimatoprost
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The U.S. Food and Drug Administration recently seized $2 million in applicator tubes of Age Intervention Eyelash, which may cause vision loss, according to a press release from the agency.
Age Intervention Eyelash is sold and distributed by Jan Marini Skin Research. The product contains the prostaglandin bimatoprost, which is approved by the FDA for treating elevated IOP.
For patients already using bimatoprost, using Age Intervention Eyelash simultaneously may cause optic nerve damage, as the extra dose of bimatoprost may reduce the prescription drug's effectiveness, according to the release.
Additionally, using Age Intervention Eyelash may cause macular edema and uveitis in certain people, the release said.
"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. Before a new drug product may be legally marketed, it must be shown to be safe and effective, and approved by FDA," the release said.
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, according to the release.
Shortly after the seizure, Allergan announced that it had filed lawsuits against seven companies, including Jan Marini Skin Research, for marketing and selling eyelash products containing bimatoprost, according to an article in the Los Angeles Times.
Allergan's glaucoma treatment Lumigan contains bimatoprost.
"Glaucoma specialist Murray Johnstone noticed in 1996 that patients using the solutions grew longer lashes. He patented his finding and licensed it to Irvine-based Allergan," the article said.
Allergan had requested a court order to keep the companies from selling products containing bimatoprost, the article said.
FDA spokesman Brad Swezey told The Wall Street Journal that the eyelash product seizure did not stem from any report of patient injury, according to a press release from Athena Cosmetics, one of the seven companies being sued by Allergan.
However, Athena Cosmetics has decided to stop selling the current formulation of its eyelash growth product RevitaLash due to the "possible public concern over bimatoprost created by the FDA's news release," the Athena Cosmetics release said.