The U.S. Food and Drug Administration (FDA) has issued a warning about the risks of unapproved eye products after reports that some of them could pose a health risk. The agency says it also has concerns about quality issues of these products, including not being sterile.
Some major companies, including CVS Health, Walgreens, Boiron, and OcluMed, have received warning letters from the agency after claims that they are marketing and selling unapproved products for conditions like cataracts, glaucoma, and conjunctivitis, also known as “pink eye”.
Earlier this year, the FDA found that one product “Artificial Tears Lubricant Eye Drops”, manufactured by Global Pharma Healthcare and distributed by EzriCare and Delsam Pharma, was linked to at least 8 cases of blindness, as well as at least three deaths.
The product was sold by Amazon, Target, Walmart, and CVS and was recalled. However, there had already been 68 cases of infections reported across 16 US states.
The FDA said it is “committed to ensuring the medicines Americans take are safe, effective, and of high quality. 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.”
According to recent statistics, 117.45 million Americans used eye drops and eye wash in 2020. Eye drops are used to replace the eye’s natural moisture and relieve dryness and irritation. They can also promote surface healing in some injuries or infections and remove any contamination.
Anti-allergy eye drops can also provide some comfort for allergy sufferers. Glaucoma drops are often recommended by doctors to reduce the risks of blindness and alleviate pressure inside the eye, which can be harmful to the retina as it’s very sensitive.
The FDA has recommended that anyone using an unapproved eye drop should speak to their healthcare provider, as illegally marketed products can be harmful. Drugs that are applied to the eyes can cause problems, as they can bypass some of the body’s natural defenses.