More infectious eye drops and an FDA warning

The following is an article I’m adding to my series of bad eye drops. MSM is a controversial OTC product as there is a lot of online banter about reversing cataracts and other broad claims that have yet to have any adequate human trials to back up. Worse is when this comes in a contaminated eyedrop capable of possibly causing severe eye infections. Fortunately the FDA is blowing the whistle on this particular problem.

FDA warns against the use of certain illegally marketed methylsulfonylmethane (MSM) eye drops due to contamination

Aug 23, 2023

Martin David Harp

News

Article

The organization says to stop using Dr. Berne’s and LightEyez MSM drops immediately due to bacterial contamination, fungal contamination, or both.

(Image Credit: AdobeStock/Regina)

(Image Credit: AdobeStock/Regina)

The US Food and Drug Administration (FDA) is warning consumers to cease use and not purchase Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops – Eye Repair due to bacterial contamination, fungal contamination, or both.

According to the FDA,1 using contaminated eye drops could result in a minor to serious vision-threatening infection which could possibly progress to a life-threatening infection.

While the FDA states they are unaware of any adverse event reports associated with the use of either product, patients who have signs or symptoms of eye infection after use should consult their health care professional immediately.

The Dr. Berne’s and LightEyez eye drop products contain methylsulfonylmethane (MSM) as an active ingredient. According to the FDA, these products are unapproved drugs and illegally marketed in the US. There are no legally marketed ophthalmic drugs that contain MSM as an active ingredient in the US.1

The FDA conducted sampling and testing based on the products’ intended use in the eyes, as well as because of the recent uptick in manufacturing issues with eye drops. According to the FDA, testing showed the products were contaminated with microbes and were not sterile.

Furthermore, the FDA identified bacillus bacterial contamination and exophiala fungal contamination in Dr. Berne’s MSM Drops. While the LightEyez MSM Eye Drops showed bacterial contamination from pseudomonas, mycobacterium, mycolicibacterium, and methylorubrum.1

According to the FDA, Dr. Berne agreed to a voluntary recall of their eye drops on August 21, 2023. While LightEyez Limited has not responded to the FDA’s request for a discussion over the concerns and has taken no action regarding a recall.1

References:

FDA warns consumers not to purchase or use certain methylsulfonylmethane (MSM) eye drops due to contamination. FDA. Press Release. August 22, 2023. Accessed August 23, 2023.https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-certain-methylsulfonylmethane-msm-eye-drops

This article comes from: https://www.ophthalmologytimes.com/view/fda-warns-against-the-use-of-certain-illegally-marketed-methylsulfonylmethane-msm-eye-drops-due-to-contamination?utm_source=sfmc&utm_medium=email&utm_campaign=08262023_OT_OYS-23-OPD0522_NOV-23-OPD0533_eNL_Oyster%20Point%20Dry%20Eye%20TRC_Novartis%20Viewpoints&eKey=ZWphY2NvbWFAYW9sLmNvbQ==