The US Food and Drug Administration (FDA) issued warning letters to eight firms marketing unapproved ophthalmic drug products.
These warnings come amidst a host of serious adverse reports linked to contaminated artificial teardrops in the US that has led to 14 patients with vision loss, an additional four requiring enucleation, and four deaths.
The FDA states that the eye products addressed in the latest warning letters are illegally marketed to treat conditions such as conjunctivitis, cataracts, and glaucoma among others. It also cites quality issues related to product sterility.
According to the agency, these unapproved products pose elevated risk of harm to users as the products can bypass some of the body’s natural defences.
“The FDA is committed to ensuring the medicines Americans take are safe, effective and of high quality. 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,” said Ms Jill Furman, director of the office of compliance for the FDA’s Centre for Drug Evaluation and Research.
“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.”
The companies that received the warning letters and their unapproved products:
- Boiron Inc.
- Opaque 1 Eye Drops
- CVS Health
- CVS Health Pink Eye Relief Drops
- DR Vitamin Solutions
- Vision Clarity Eyedrops
- Life Extension Brite Eyes III
- Can-C Eye Drops
- Longevity Science Visual Ocuity
- Natural Ophthalmics, Inc.
- Women’s Tear Stimulation Dry Eye Drops
- Allergy Desensitization Eye Drops
- Ortho-K Thing (Daytime) Eye Drops
- Cataract Eye Drops with Cineraria
- OcluMed LLC
- OcluMed Eye Drops
- Similasan AG/Similasan USA
- Similasan Dry Eye Relief
- Similasan Complete Eye Relief
- Similiasan Allergy Eye Relief
- Similasan Kids Allergy Eye Relief
- Similasan Red Eye Relief
- Similasan Pink Eye Relief
- Similasan Kids Pink Eye Relief
- Similasan Aging Eye Relief
- Similasan Computer Eye Relief
- Similasan Stye Eye Relief
- Similasan Pink Eye Nighttime Gel
- Similasan Dry Eye Nighttime Gel
- TRP Company, Inc.
- 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 PF
- Walgreens Boots Alliance, Inc.
- Walgreens Allergy Eye Drops
- Walgreens Stye Eye Drops
- Walgreens Allergy Eye Drops
- Walgreens Pink Eye Drops
The companies are required to respond within 15 days of receipt of the letters and take corrective action. Failure to respond to the letters will result in legal action, with some companies placed on import alert which prevents entry of their products into the US.
The FDA recommends that consumers who have used eye products listed in the letters to seek healthcare advice.
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