In the midst of a wave of eyedrop lawsuits, primarily directed against EzriCare Artificial Tears and Delsam Pharma Artificial Eye Ointment, the FDA sent a warning letter to eight companies that the agency accuses of selling unapproved eye products, some of which contain silver, an ingredient that with long-term usage may cause the skin to turn blue, a condition known as argyria.
Earlier this year, the FDA recalled EzriCare and Delsam artificial tear products after the agency determined that the eye drops could cause a drug-resistant bacteria to develop that may cause permanent vision loss and blood infections. The products in question caused at least one death and numerous illnesses in other patients, leading to several eye drop lawsuits being filed.
According to an FDA press release, the companies that received warning letters are:
- CVS Health (product: CVS Health Pink Eye Relief Drops)
- Walgreens (products: Walgreens Allergy Eye Drops, Walgreens Stye Eye Drops, and Walgreens Pink Eye Drops)
- Boiron
- DR Vitamin Solutions
- Natural Ophthalmics
- OcluMed
- Similasan
- TRP Company
In response to the warning letter, which was issued in September, CVS has removed its Pink Eye Relief Drops from the shelves and is offering consumers a full refund. The companies named by the FDA had 15 days to respond to the agency stating how they would rectify the violations. The agency suggested that consumers who have been using any eye drops sold by the eight companies speak with their healthcare professional and report any adverse reaction to the agency’s MedWatch program.
The unapproved eye products are illegally marketed to treat conditions such as conjunctivitis (“pink eye”), cataracts, glaucoma and others. In addition to some of the products containing silver, which may be characterized as “silver sulfate, silver sulphate or argentum,” the FDA warning letters also cite product sterility failures due to quality control issues.
“The FDA is particularly concerned that these illegally marketed, unapproved ophthalmic drug products pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses,” the agency stated.
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