Copycat eye drops? FDA issues warning for contaminated eye drops that can cause infections

Three counterfeit products included in the FDA warning.
Three counterfeit products included in the FDA warning.

The U.S. Food and Drug Administration (FDA) has issued yet another warning in the long list of eye drop-related recalls and alerts announced over the last year.

This time, the organization is cautioning consumers to double-check their eye drops for authenticity, as a number of copycats have made their way to the U.S.

The FDA offered several examples of counterfeit products, which have been packaged to look strikingly similar to authentic Lumify artificial tears produced by Bausch + Lomb. According to the announcement, these off-brand versions are not approved for use and should not be available for sale in the U.S. at all, as they pose a risk of infection, irritation, or injury.

Here is what we know so far.

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Knockoff eye drops

The FDA's warning cited three specific counterfeit products posing as a legitimate product, Bausch + Lomb’s Lumify drops: South Moon, Rebright and FivFivGo.

The packaging of the knockoffs is made to closely resemble that of the real Lumify drops, featuring white lettering on a grey background and an image of an eye with a pale purple iris. The bottles inside the packaging also mimic that of Lumify exactly, with the same purple cap and grey label with white lettering.

At first glance, it is very easy to mistake the copycats for the real thing, said the FDA. The primary differences are in the actual words written on the packaging, including bullet points explaining the product's use and the brand name,

South Moon, Rebright and FivFivGo are not approved for sale in the U.S., the FDA warned, and their packaging falsely claims they can treat eye conditions such as glaucoma, which in reality can be treated only with prescription drugs or surgery.

After obtaining samples of South Moon and Rebright eye drops, the FDA determined not only that neither product contained brimonidine tartrate, the active ingredient in Lumify, but South Moon eye drops were also contaminated with bacteria called Burkholderia cepacia complex that can cause antibiotic-resistant infections. FDA was unable to obtain FivFivGo samples by the time the warning was released.

The FDA has yet to receive reports of adverse reactions that name South Moon, Rebright or FivFivGo specifically, but they have received reports of possibly fake Lumify causing eye irritation, pain and infection.

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Check for the authentic

The authentic Lumify product.
The authentic Lumify product.

The FDA is investigating the origin of these products, which are not supposed to be available for sale in any U.S. state. Regardless, anyone with a product they doubt the authenticity of should dispose of it. Those who may have already used a counterfeit product should consult with their doctor and seek immediate medical attention for any signs of infection.

While the copycat packaging is deceptively similar to that of the authentic product, there are signs to look out for: Authentic Lumify is labeled as such as is produced by Bausch + Lomb, with a list of ingredients that includes brimonidine tartrate as the active ingredient.

Some copycat products may be falsely labeled with “Bausch + Lomb” at the top of the packaging similar to the authentic packaging. One way to be sure, the FDA advises, is to purchase your eye drops from reputable retailers such as state-licensed pharmacies and beware of online retailers.

Healthcare professionals and consumers should report adverse events or side effects related to the use of counterfeit eye drops via an online report at MedWatch Online Voluntary Reporting Form.

This article originally appeared on USA TODAY: FDA issues warning for contaminated eye drops that are fake, knockoffs