The FDA issued a warning to consumers on August 22, 2023, to not purchase and immediately stop use of two methylsulfonylmethane (MSM) eye drops due to potential contamination.
First things first: which eye drops?
We’ll just get just straight to it:
- Dr. Berne’s MSM Drops 5% Solution
- Distributed by Dr. Berne’s Whole Health Products
- LightEyez MSM Eye Drops
- Distributed by LightEyez Limited
What exactly is MSM?
Methylsulfonylmethane (MSM) is an organic sulfur-containing chemical compound that is naturally occurring in humans, plants, and animals and has been used as a dietary joint supplement due to its anti-inflammatory properties.
To note, it is also the active ingredient in both eye drop products—although it has multiple unproven claims online that it can be used to treat various eye conditions such as dry eye and floaters.
According to the FDA, “These products are unapproved drugs and illegally marketed in the U.S. There are no legally marketed ophthalmic drugs that contain MSM as an active ingredient.”
What’s the risk for use?
There’s two types of potential contamination—bacterial or fungal (or even both)—that have been identified in these products.
- Dr. Berne’s drops may contain:
- Bacillus spp. (bacterial)
- Exophiala spp (fungal).
- LightEyez drops may contain:
- Pseudomonas spp
- Mycobacterium spp
- Mycolicibacterium spp
- Methylorubrum spp
So how were these discovered?
The agency sampled and tested both eye drop brands, which illustrated that each product was contaminated with microbes and, as a result, were not sterile (an FDA requirement for all eye drops to be considered safe for use).
Any reports of adverse reactions?
As of August 22, 2023, not so far.
However, the FDA stated that, “Using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection.
Have the manufacturers responded?
Sort of…
The FDA stated that Dr. Berne “verbally agreed” to voluntarily recall its eye drop product on August 21, 2023.
As of Wednesday evening, August 23, 2023, the eye drops have been removed from the manufacturer’s website.
How about LightEyez?
The agency reported also reaching out to the company (via email) regarding its concerns over the LightEyez products distributed in the U.S. and “further steps to protect consumers from using the contaminated eye drops.”As of August 22, 2023, the FDA has not received a response from the company.
As of the morning of August 24, 2023, the products are still available online.
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 bacterium 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.