FDA warns of copycat eye drops that may be contaminated and ineffective
By Mira Cheng, CNN
(CNN) — The US Food and Drug Administration has issued a warning against buying or using South Moon, Rebright and FivFivGo eye drops because of a potential risk of infection.
The agency said in an announcement Wednesday that these unapproved copycat products can be easily mistaken for Bausch + Lomb’s Lumify drops, which are approved to ease eye redness.
FDA testing of South Moon eye drop samples showed that they were contaminated with Burkholderia cepacia complex, a type of bacteria that could cause antibiotic-resistant eye infections. Rebright testing was negative for contamination, and FivFivGo samples couldn’t be obtained, the FDA says, but it recommends that consumers not use these products.
The tested products also lacked brimonidine tartrate, the active ingredient in Lumify.
“South Moon, Rebright and FivFivGo eye drops are unapproved drugs and should not be available for sale in the U.S.,” the FDA said in the announcement. “They claim to treat eye conditions such as glaucoma, which is treated with prescription drugs or surgery.”
The agency says the origins of these products remain unclear, but it continues to investigate.
No adverse events have been reported specifically related to the South Moon, Rebright or FivFivGo products, the FDA said. However, there have been reports of possibly fake Lumify eye drops resulting in eye irritation, pain and infection.
“Consumers can be confident that authentic Lumify redness reliever eye drops are made with the highest standards of safety and efficacy,” Bausch + Lomb said in an email to CNN. “We’re working closely with the FDA and our authorized retail partners to help protect individuals from copycat products.”
The FDA advises consumers to discard these copycat products immediately and seek medical care if they have any signs or symptoms of an eye infection. Consumers should beware of online retailers selling copycat products and should buy eye products only from reputable retailers such as licensed pharmacies.
Over the past year, the FDA has issued numerous warnings about contaminated eye drop products, and the US Centers for Disease Control and Prevention reported that the use of some drops contaminated with a drug-resistant bacteria resulted in patients experiencing vision loss, surgical removal of eyes and even death.
Health care professionals and consumers can report adverse events or quality problems related to eye drop products to the FDA’s MedWatch program.
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