The FDA recently sent warning letters to several companies, including CVS and Walgreens, for manufacturing or marketing unapproved eye products that are potentially harmful. These products are marketed as treatments for conditions such as conjunctivitis, cataracts, and glaucoma. The agency expressed concern that these products bypass the body's natural defenses and pose a heightened risk of harm to users. Some of these products contain silver compounds that can cause discoloration of the eye, skin, and other tissues. The FDA also cited quality issues related to the sterility of the products.
The FDA issued warning letters to Boiron Inc., CVS Health, DR Vitamin Solutions, Natural Ophthalmics, Inc., OcluMed LLC, Similasan AG/Similasan USA, TRP Company, Inc., and Walgreens Boots Alliance, Inc. In addition to the warning letters, the agency placed some of these companies on import alert to prevent their products from entering the United States.
The FDA has asked these companies to respond within 15 days and indicate how they will correct the violations. Failure to make corrections may result in legal action, including seizure of the products or a court order to stop manufacturing or distributing the unapproved eye products.
Healthcare professionals recommend that consumers who have been using these unapproved eye products should stop immediately and consult their eye doctor for any potential issues. Symptoms such as eye redness, discharge, blurred vision, and eye pain may indicate an infection, and individuals should seek medical attention if they experience these symptoms after using an eye product.
While the FDA's action against unapproved eye products is important, healthcare providers emphasize that patients should not be discouraged from using eye drops prescribed by their doctor. They recommend seeking advice from an eye care professional to ensure the safety and effectiveness of eye drops for each individual's condition.
CVS and Walgreens have both announced that they are pulling these products off their shelves and offering full refunds to customers. Similasan stated that to its knowledge, there have been no adverse events linked to the use of Silver Sulfate, which is used in its products. The company is working with the FDA to address the issues raised and hopes to resolve the matter quickly. Boiron Laboratories USA pointed out that the FDA did not cite specific safety issues with its product, Optique 1 Eye Drops, and reassured consumers that there is no reason to be concerned about past use of their product.
Consumers who suspect adverse effects from using these products can report them to the FDA's MedWatch program.