- The FDA is warning consumers to avoid eye drop brands that they say are copycat products.
- Eye drop brands South Moon, Rebright or FivFivGo should not be purchased since they are copycat products, according to a new FDA report.
- These copycat eye drops are dangerous since the manufacturing is not regulated in the same way as approved eye drops.
In the warning, the agency cited the brands South Moon, Rebright or FivFivGo due to the risk of infection. These eye drops are copycat products that can be mistaken for Bausch + Lomb’s Lumify brand eye drops.
The eyedrops from South Moon, Rebright and FivFivGo are not FDA-approved. The agency said that the brands state that the drops can help with glaucoma, but that condition is only treated with surgery or prescription drugs.
South Moon and Rebright eye drops were both tested by the agency. The South Moon eye drops were contaminated with the bacteria Burkholderia cepacia complex, which could lead to an infection that is unable to be treated by antibiotics.
Although Rebright was not found to be contaminated, FDA does not recommend that consumers purchase these eye drops.
FivFivGo samples were not available to be tested.
“While it may be tempting to buy these copycat products, there can be risk associated with them,” said Vicente Diaz M.D., M.B.A., Chief of Ophthalmology at Yale School of Medicine. “These are made by much smaller enterprises, and as such the manufacturing practices are not regulated the same way. There was a recent problem with artificial tear manufacturers for the same reason, and that led to blindness and even death.”
The testing of the Rebright and South Moon eye drops revealed that they did not contain the active ingredient in Lumify: brimonidine tartrate.
“The origin of these products is currently unclear, and FDA continues to investigate. South Moon is labeled as made by Shantou Cross-border Premium Products E-Commerce Co. Ltd. in China,” according to the report.
If you have any of these products the FDA recommends
“These products are not regulated the same way and the smaller manufacturers may not have the best sterility practices,” Diaz explained. “The risk is that there is the potential for contamination which can lead to ocular and systemic infections.”
The report noted that “FDA has not received any adverse event reports that specifically name the South Moon, Rebright or FivFivGo products. However, the agency has received reports related to possibly fake Lumify, including product quality concerns, eye irritation, pain and infection.”
The FDA encourages consumers to purchase eye products from reputable retailers, which includes state-licensed pharmacies. Also, be cautious of online retailers selling products with inaccurate information.
When looking for reputable eye drops, Diaz recommends the following:
- For dry eye, Refresh and Systane are the leading brands.
- For eye redness, Lumify by Bausch & Lomb, is a brimonidine-based product that comes from a well-known brand with no known manufacturing issues.
Last year, the FDA issued a drug safety alert over eye drops after concerns that they were contaminated.
Ultimately, 27 over-the-counter eye drop brands were voluntarily recalled after they were linked to bacterial infections.
The FDA is warning consumers to avoid certain brands of “copycat” eye drops. The agency warns that these brands may increase the risk of infection.
Source link : https://www.healthline.com/health-news/why-the-fda-issued-a-warning-for-copycat-eye-drops
Publish date : 2024-02-06 00:15:13
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