FDA Warns Companies About Unapproved Ophthalmic Products

The FDA put eight companies on notice for marketing unapproved products for a variety of eye conditions.

The eight companies — including drugstore chains Walgreens and CVS — received warning letters about illegal marketing of unapproved drugs to treat conjunctivitis, cataracts, glaucoma, and other ophthalmic conditions. The FDA gave the companies 15 days to respond to the warnings, including information about how they plan to correct the violations.

“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,” agency officials said in a statement. “Some of these eye products are labeled to contain silver, which may be characterized as silver sulfate, silver sulphate, or argentum. Long-term use of these drugs containing silver can cause some areas of the skin and other body tissues, including in the eye, to permanently turn gray or blue-gray, which is called ‘argyria.'”

By using unapproved products, consumers might delay or stop medical treatments that are deemed safe and effective by the FDA, the statement continued. The agency encouraged consumers who might be using any of the products to speak with their healthcare providers.

In addition to the drugstore chains, other companies that received warning letters were Boiron, DR Vitamin Solutions, Natural Ophthalmics, OcluMed, Similasan, and TRP Company. The statement had embedded links to the letters sent to the companies, including the specific products covered by the warnings. Additionally, the FDA placed some of the companies on import alert.

The FDA reserved the right to take additional regulatory or enforcement actions, as the ongoing investigation into the eye products progresses.

“We will continue to investigate potentially harmful eye products and work to ensure violative products stay off store shelves so that consumers can continue taking the medicines they need without concern,” said Jill Furman, JD, director of the FDA’s Center for Drug Evaluation and Research Office of Compliance.

The FDA action was met with approval from the American Academy of Ophthalmology (AAO).

“The American Academy of Ophthalmology supports the FDA’s recent letters warning against the manufacturing and marketing of unapproved ophthalmic drugs, including products containing harmful ingredients such as silver, which is known to cause potential long-term health complications,” an AAO spokesperson wrote in a statement in response to a request from MedPage Today. “The Academy continues to support efforts to protect the public from medical products being sold illegally.”