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FDA Warns CVS, Walgreens, Others About Unapproved Eye Drops

Products were ‘illegally’ marketed to treat pink eye, cataracts, glaucoma


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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.

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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 Pharmacy

  • ​​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. ​ ​

Walgreens

  • Walgreens Allergy Eye Drops, Walgreens Stye Eye Drops and Walgreens Pink Eye Drops. As of the publication of this article, the company had not responded to AARP’s request for comment. ​ ​ ​

Boiron

  • Optique 1 Eye Drops. The company told AARP that the FDA’s letter did not cite safety issues and that the product is manufactured in FDA-inspected facilities. “There is no reason for consumers to be concerned about past use of Optique 1,” it said, noting that the product has been sold in the U.S. since 1995.​ ​
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Dr. Vitamins

  • Vision Clarity Eye Drops, Life Extension Brite Eyes III, Can-C Eye Drops, Longevity Science Visual Ocuity. As of the publication of this article the company had not responded to AARP’s request for comment.​ ​

Natural Ophthalmics

  • Women’s Tear Stimulation Dry Eye Drops, Allergy Desensitization Eye Drops, Ortho-K Thin (Daytime) Eye Drops, Ortho-K Thick (Night) Eye Drops, Tear Stimulation Forté Dry Eye Drops, Cataract Eye Drops with Cineraria.  As of the publication of this article the company had not responded to AARP’s request for comment.​ ​

OcluMed

  • OcluMed Nutritional/Lubricant Eye Drops. The company acknowledged receipt of the FDA’s warning letter and plans to respond accordingly. “In the 14+ years our company has been in business, we have never received a medically verified complaint of adverse reactions,” it said.

Similasan AG

  • Similasan Dry Eye Relief, Complete Eye Relief, Allergy Eye Relief, Kids Allergy Eye Relief, Red Eye Relief, Pink Eye Relief, Kids Pink Eye Relief, Aging Eye Relief, Computer Eye Relief, Stye Eye Relief, Pink Eye Nighttime Gel, Dry Eye Nighttime Gel. The company said that though it understands the concerns about certain eye drops, all of its products are safe to use and there have been no recalls. ​ ​ ​

TRP Company

  • Dryness Relief, Pink Eye Relief, Allergy Eyes Relief, Red Eye Relief, Eye Strain Relief, Eye Lid Relief, Aging Eye Relief, Blur Relief, Floaters Relief, Twitching Relief, Stye Relief, Dryness Relief.  As of the publication of this article the company had not responded to AARP’s request for comment.​​​

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