The Food and Drug Administration has sent warning letters to eight companies for manufacturing or selling unapproved eye drops that it says were illegally marketed to treat pink eye, cataracts, glaucoma and other conditions.
Claims that unapproved drugs can treat or prevent serious conditions can delay or end medical treatments that have been found safe and effective, the FDA says.
The agency says in a news release that it is particularly concerned over a “heightened risk” of harm because any drug applied to eyes may bypass the body’s natural defense system. Some of the cited eyedrops contain silver, which may be listed on the bottles as silver sulfate, silver sulphate or argentum. Long-term use of these ingredients can cause some areas of the skin and other body tissues, such as the eye, to turn gray or blue-gray. Additionally, granular deposits of silver in the conjunctiva and cornea may cause decreased night vision, the FDA notes.
“The FDA is committed to ensuring the medicines Americans take are safe, effective and of high quality,” says Jill Furman, director of the office of compliance at the FDA’s Center for Drug Evaluation and Research. “When we identify illegally marketed, unapproved drugs and lapses in drug quality that pose potential risks, the FDA works to notify the companies involved of the violations.”
In each of the warning letters, the FDA says it views the products as “not generally recognized as safe and effective.” And although the majority of the products cited are labeled as homeopathic drugs, they are subject to the same requirements as other drugs.
Consumers who have used the eye products cited should speak with their health care professional. The companies have 15 days to respond to the warning letters to indicate how they will correct the violations.
Unapproved eye drop brands and products
- CVS Health Pink Eye Relief Drops. The company says that it has stopped selling the eye drops and that customers can return the product to its stores for a refund.