Other manufacturers — including Similasan AG and OcluMed LLC — received warning letters as well.
The FDA’s warning letters said the products in question, which were falsely labelled as potential treatments for conditions like glaucoma, cataracts, and pink eye, should be modified if the companies and manufacturers that make and distribute them want to avoid legal action.
“The FDA is committed to ensuring the medicines Americans take are safe, effective and of high quality,” Jill Furman, Director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research, said in a statement. “When we identify illegally marketed, unapproved drugs and lapses in drug quality that pose potential risks, the FDA works to notify the companies involved of the violations.”
Ms Furman wrote in the letter sent to Walgreens: “Your ‘Walgreens Allergy Eye Drops,’ ‘Walgreens Stye Eye Drops,’ and ‘Walgreens Pink Eye Drops’ products are especially concerning from a public health perspective. Ophthalmic drug products, which are intended for administration into the eyes … pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defences.”
In her letter to CVS, Ms Furman said that the company’s “CVS Health Pink Eye Relief Drops” are “especially” concerning for the same reason.
In a statement to The Independent, a Walgreens representative said, “Out of an abundance of caution, we are pulling these products. Customers who have purchased these products can return the item to their nearest Walgreens for a full refund.” A representative from OcluMed LLC said, “We are taking the FDA’s warning letter very seriously, the letter was solely based on claims that we are currently in the process of rectifying...in over 14 years of being in business we have never received a verified [account] of any adverse reactions.” A statement from Similasan AG said, “We understand that the FDA shares our values of health and safety, and we are engaging with them to better understand the issues raised and provide updated documentation around our manufacturing processes.”
The companies addressed by the FDA have 15 days to respond to the agency, outlining the ways in which they plan to correct the violations.
The move comes after months of warnings about various eye drop products available at drug stores.
In January, the Centers for Disease Control and Prevention (CDC) began investigating a product called EzriCare Artificial Tears that was linked to vision loss, hospitalisation, and even the death of one person who used the product and developed a bloodstream infection. The product caused at least 50 infections in 11 states.
Two months later, the FDA warned the public about a product called Brimonidine Tartrate Ophthalmic Solution, 0.15 per cent. It was recalled due to manufacturing issues; some of the bottles that the product came in were cracked.
Just three weeks ago, the FDA released a statement warning the public not to use certain over-the-counter eye drops due to “bacterial contamination, fungal contamination, or both”. The statement advised readers to “immediately stop using” two products: Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops Eye Repair. “Using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection,” the statement said.
If you have any questions about whether products in your home are safe to use, you should consult an eye doctor. Per the American Academy of Ophthalmology (AAO), you should only use eye drops “exactly when and how your doctor tells you to”.
The Independent has contacted CVS for comment.
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