The Food and Drug Administration (FDA) has sent warning letters to drugstore chains Walgreens and CVS, accusing them of illegally marketing eye care products.
Other manufacturers – including Boiron, Inc; Similasan AG; and OcluMed LLC – also received warning letters.
The FDA warning letters say the products in question, which have been falsely labeled as potential treatments for conditions such as glaucoma, cataracts and conjunctivitis, should be changed if the companies and manufacturers that make them and distribute them want to avoid legal proceedings.
“The FDA is committed to ensuring that the medications Americans take are safe, effective and of high quality,” said Jill Furman, director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research. in a press release. “When we identify illegally marketed and unapproved drugs and drug quality defects that pose potential risks, FDA works to notify the companies involved of the violations.”
Ms. Furman wrote in the letter sent to Walgreens: “Your products ‘Walgreens Allergy Eye Drops,’ ‘Walgreens Stye Eye Drops,’ and ‘Walgreens Pink Eye Drops’ are of particular concern from a public health perspective. Ophthalmic drug products, intended for administration into the eyes… present a greater risk of harm to users because the route of administration of these products bypasses some of the body’s natural defenses.
In her letter to CVS, Furman said the company’s “CVS Health Pink Eye Relief Drops” are “particularly” concerning for the same reason.
In a statement to The independent, a Walgreens representative said, “Out of an abundance of caution, we are removing these products. Customers who purchased these products can return the item to their nearest Walgreens for a full refund.
Companies contacted by the FDA have 15 days to respond to the agency, describing ways they plan to correct the violations.
The move comes after months of warnings about various eye drop products available in pharmacies.
In January, the Centers for Disease Control and Prevention (CDC) began investigating a product called EzriCare Artificial Tears, which was linked to vision loss, hospitalization and even death in someone who used the product and developed a blood infection. The product has 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 percent. It was recalled due to manufacturing problems; some of the bottles the product arrived in were cracked.
Just three weeks ago, the FDA issued 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 Repair eye drops. “Use of contaminated eye drops could result in a minor to serious vision-threatening infection, which could eventually progress to a life-threatening infection,” the statement said.
If you have any questions about the safety of using products in your home, you should consult an ophthalmologist. According to the American Academy of Ophthalmology (AAO), you should only use eye drops “exactly when and how your doctor directs you to do so.”
The independent contacted CVS; Boiron, Inc.; Similasan AG; and OcluMed LLC for comments.