WOONSOCKET, R.I. — The US Food and Drug Administration sent warning letters to CVS, Walgreens, and six other retail companies this week for selling over-the-counter eye drops that were illegally marketed and pose a public health concern.
US regulators said they consider the eye drops to be unapproved drugs, a violation of federal law. The drops are marketed, regulators say illegally, to treat conditions like conjunctivitis (also known as “pink eye”), cataracts, glaucoma, and other issues. Some of these eye drops include those marketed and branded by CVS and Walgreens.
The labels on some of the eye products, the FDA said Tuesday, say the products contain silver. Long-term use of drugs containing silver can cause areas of the skin and other body tissue, including the eye, to permanently turn gray or blue-gray, which is called “argyria.”
“Your ‘CVS Health Pink Eye Relief Drops’ is not generally recognized as safe and effective,” read the FDA’s letter to Karen S. Lynch, the president and CEO of Rhode Island-based CVS. The name of the retail giant’s contracted manufacturer for these drops was redacted.
Three different Walgreens-branded eye drops were deemed “concerning” by the FDA, including “Walgreens Allergy Eye Drops,” “Walgreens Stye Eye Drops,” and “Walgreens Pink Eye Drops.”
The pharmacy retailers have 15 days to respond to the FDA’s letter, which will require them to correct the violations. CVS and Walgreens claimed Wednesday to have stopped selling the eye drops named in the warning letters. Customers who previously purchased them can get full refunds, spokespeople from both chains said in a statement.
“Failure to correct the violations promptly may result in the FDA pursuing legal action,” the agency said in a news release. That action could include product seizure and/or a court order that would require a company to stop manufacturing and distributing an unapproved product.
Jill Furman, director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research, said the agency will “continue to investigate” potentially harmful eye products and “ensure violative products stay off store shelves so that consumers can continue taking the medicines they need without concern.”
The FDA advised consumers using the eye products to speak to their doctors, and report any adverse reaction to the agency’s MedWatch program.
OcluMed LLC, TRP Company, Inc., DR Vitamin Solutions, Natural Opthalmics, Inc., Boiron Inc., and Similasan AG were also sent warning letters. US regulators placed Switzerland-based Similasan AG on an import alert list to stop their products from entering the country and reaching consumers. The FDA noted that Similasan AG’s facilities failed to follow basic quality and sterilization processes.
A spokesperson from Boiron told Bloomberg that the FDA did not cite safety issues or quality concerns about its eye drops. The company has sold the product in the United States since 1995. A spokesperson for OcluMed told the business publication it never received a “medically verified complaint” of bad reactions.
Representatives from the other companies who received warning letters from the FDA did not immediately respond to inquiries by the Boston Globe.