Eyedrops FDA Warning (News21USA): Federal health officials are advising consumers to stop using more than two dozen over-the-counter eye drops because of the potential risk of eye infection that can lead to partial vision loss or blindness.
The Food and Drug Administration issued an alert Friday flagging 26 eye care products, including eye drops and gels from CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target up&up and Velocity Pharma.
The federal agency on Wednesday recommended that the manufacturer recall all lots of those products after agency investigators found unsanitary conditions at a manufacturing plant, according to the FDA news release. Bacterial tests came back positive in critical drug production areas at the plant, which the agency did not immediately identify.
The FDA said it had not received any reports of infections associated with these products, but was encouraging health care professionals and patients to report any cases to the agency.
It is imperative that these products be sterile, regulators said, because medications applied to the eyes bypass some of the body’s natural defenses.
The FDA said consumers should properly dispose of these products by taking them to a drug take-back site or checking to see if a product was included on the FDA’s “disposable list” of drugs that can be safely discarded at home.
CVS, Rite Aid and Target are removing the products from their stores and websites, the agency said. Leader, Rugby and Velocity brand products may still be available in stores and online and should not be purchased, federal regulators said.
Rite Aid confirmed through a spokeswoman that it was removing “applicable Rite Aid brand products” from store shelves. A CVS spokeswoman said the retailer “immediately stopped in-store and online sales of all products supplied by Velocity Pharma within the CVS Health branded eye product portfolio” and that customers could return those products to get a full refund. The other retailers did not immediately respond to requests for comment.
There have been other recent reports of problems with eye products.
In January, the Centers for Disease Control and Prevention and the FDA warned consumers to stop using EzriCare artificial tears and Delsam Pharma artificial tears. The eye drops were linked to a drug-resistant strain of Pseudomonas aeruginosa bacteria, which was linked to at least four deaths and vision loss in 14 patients.
Apotex, a Canadian pharmaceutical company, recalled prescription eye drops in March after some bottle caps developed cracks, which could compromise the sterility of the product.
Experts say that eye drops are generally safe to use. By 2024, 123 million Americans are projected to use eye drops, according to Statista, a market research firm.