Sarah Silbiger/Getty Images
The FDA sent warning letters to eight companies for marketing and manufacturing unapproved eye products.
CNN –
The U.S. Food and Drug Administration on Monday sent warning letters to CVS, Walgreens and other companies for making and marketing unapproved eye products that the agency said could pose a risk to people who use them.
The agency said the products were being marketed illegally to treat conditions such as conjunctivitis, conjunctivitis, glaucoma and cataracts, and some warnings cited sterility problems with the products.
The agency has issued warning letters to CVS Health, Walgreens Boots Alliance Inc., Boiron Inc., DR Vitamin Solutions, Natural Ophthalmics Inc., OcluMed LLC, Similasan AG/Similasan USA and TRP Company Inc. Some companies have also been placed on import alert to prevent products from entering the United States.
“The FDA is particularly concerned that these illegally marketed, unapproved ophthalmic drugs pose an increased risk of harm to users because drugs administered into the eyes bypass some of the body’s natural defenses,” it said. Some of the products contain silver, which can cause the skin or eye areas to become permanently gray or blue-gray. People may also delay or stop safe and effective medical treatments while taking these unapproved medications, the agency said.
People who use the products included in the warning letters should speak to a health care provider, the agency said, and adverse events can be reported to the agency’s MedWatch program.
“We will continue to investigate potentially harmful eye products and work to ensure that harmful products are removed from store shelves so consumers can continue to safely take the medications they need,” said Jill Furman, director of the Office of Compliance FDA’s Center for Drug Evaluation and Research said in a statement.
Companies have 15 days to respond to the letters and say how they will address violations. Failure to make corrections could result in legal action, the FDA said.
Get CNN Health’s weekly newsletter
CNN has reached out to companies that received warning letters for a response.
In an email to CNN, CVS said it has stopped selling CVS Health brand Pink Eye Relief Eye Drops in stores and online.
“Customers who purchased this product may return it to CVS Pharmacy for a full refund,” CVS said. “We are committed to ensuring that the products we offer are safe, perform as intended and satisfy customers.”
Walgreens said it removed the products from shelves “out of an abundance of caution.”
“Customers who purchased these products may return the item to their nearest Walgreens for a full refund,” it said.
TRP said there were no reports of health concerns or adverse events associated with its ophthalmic products and said “homeopathic medicines are not illegally marketed.”
“TRP will continue to work with the FDA to ensure consumers have access to the products of their choice. “We will respond to the FDA warning letter in a timely manner,” it said in an email to CNN.
Boiron USA said it was formulating a response to the FDA.
Similasan said it would analyze the situation and reach out to partners.