FDA warns against use of possibly contaminated copycat eye drops
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Key takeaways:
- The FDA warned against use of South Moon, Rebright or FivFivGo eye drops, which can easily be mistaken for Bausch + Lomb’s Lumify brand.
- South Moon drops were contaminated with Burkholderia cepacia complex.
The FDA has issued a warning to consumers not to purchase or use South Moon, Rebright or FivFivGo eye drops because of possible contamination and risk for eye infection.
According to an agency press release, these unapproved eye drops can easily be confused with Bausch + Lomb’s Lumify eye drops (brimonidine tartrate 0.025%), an over-the-counter product approved for redness relief. The South Moon, Rebright and FivFivGo labeling claims that the products are “helpful in relieving the symptoms of eye redness, dry eyes, glaucoma, presbyopia, cataracts and ocular hypertension.”
According to the FivFivGo website, the product is also “clinically proven” to treat diabetic retinopathy and age-related macular degeneration.
The FDA tested South Moon and Rebright eye drops, which were purchased online, and found that the South Moon product was contaminated with Burkholderia cepacia complex, which can cause antibiotic-resistant infection. Although the Rebright drops tested negative for contamination, the agency advised against their use. The FDA was unable to obtain samples of FivFivGo for testing, but urged consumers to avoid this product as well.
“Patients who have signs or symptoms of an eye infection should talk to their health care provider or seek medical care immediately,” the FDA said in the release.
The testing also found that the copycat eye drops lacked brimonidine tartrate, the active ingredient in Lumify drops. The agency is still investigating the origin of these products.
While the FDA has not received any adverse event reports specifically associated with these products, it has received reports of potentially fake Lumify causing eye irritation, pain and infection. Health care providers and consumers are advised to report adverse events or side effects related to use of these products to MedWatch, the FDA’s medical product safety reporting program.
Editor’s note: This article was updated Feb. 8, 2024, to add more information about the products.
Perspective
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You are likely familiar with designer knockoffs, but a more concerning type of knockoff has entered the eye care industry. Lumify is an FDA-approved eye drop for reducing redness, containing brimonidine as the active ingredient. However, counterfeit drops lacking brimonidine have been illegally introduced into the U.S. market.
The FDA has warned about the potential risks of using unregulated eye drops, as contaminated products have led to serious health issues. You may remember last year there were reports of blindness and even death as the result of contaminated artificial tears. Bausch + Lomb is the only producer of over-the-counter brimonidine.
This trend of eyedrop recalls is reassuring, as the FDA is taking a more active role in protecting the public, but also concerning in the way these drops were able to exist in the first place. Too often the public views OTC medications to be a safe alternative to prescription ones, but this is simply untrue.
The FDA still has a long way to go in improving regulation of OTC eye drops. For now, I have been advising patients to only use brand name drops that we trust, such as those produced by Alcon, Bausch + Lomb and Johnson & Johnson, to name a few.
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