As we near the end of what is safe to call “the year of eye drop recalls” in the ophthalmic space, the FDA has issued new guidance (as of Dec. 12, 2023) for consumers and healthcare professionals (HCPs) to follow in the event of any similar situations in the future.
Let’s start with the agency’s protocol.
While the FDA stated it “actively monitors” topical ophthalmic formulations within the U.S. market via surveillance (sampling and testing these products, monitoring any side effects), it cautioned that, “facility inspections of manufacturing facilities for [over-the-counters] OTCs may not occur prior to the product being marketed.”Which explains why we’ve been hearing of so many facility inspections (and contamination issues reported) throughout the year following recalls.
So what do they recommend for consumers?
Their tips for safe eye drop use includes general practices such as:
- Washing your hands before handling the drops
- Not touching the tip of the bottle to your hands, your eyes, your clothing, or any surface area
- Stop using an eye drop if experiencing any ocular discomfort, discharge, or pain
- Reporting any issues to your HCP the FDA (more on that later)
Pretty standard... what about the products themselves?
The agency made a note regarding topical ophthalmic products, advising consumers to not use any such products that are marketed as OTC products to treat eye conditions like:
- Glaucoma
- Cataracts
- Retinopathy
- Macular degeneration
Their reasoning? “There are no OTC treatments for these conditions,” the FDA stated.
This also extends to products labeled as homeopathic as “these products should not be marketed,” the agency noted.
Are there any specific ingredients to keep an eye out for?
Two were called out:
- Silver sulfate or argentum (can cause permanent discoloration to the conjunctival epithelium due to silver deposition in the tissue referred to as argyrosis)
- Methylsulfonylmethane (MS)
- As an active ingredient
- Such products are unapproved and illegally marketed in the U.S.
So how should patients be aware of any potential issues?
The FDA recommended keeping open communication with an HCP as well as checking the FDA’s website (click here) for any recalls.
This all sounds eerily familiar …
Not surprising. You may remember back in January 2023, when the CDC called for an immediate discontinuation of EzriCare Artificial Tears (later followed by Delsam Pharma’s Artificial Tears and Artificial Eye Ointment) after reports of infections across the country.
To date, the CDC identified 81 people in 18 states with Pseudomonas aeruginosa, a type of bacteria resistant to most antibiotics.
The aftermath: Fourteen people went blind, four required enucleation, and four others died.
And we can’t forget the mass of lawsuits that have followed.
How can HCPs and patients report an ophthalmic product issue?
Per the FDA, any adverse events or quality problems with a medication should be reported to the agency’s MedWatch Adverse Event Reporting program by:
- Submitting an online report
Downloading and completing the form, then faxing to 1-800-332-0178