FDA warns certain MSM eye drops have bacterial, fungal contamination
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The FDA has issued a warning to consumers not to purchase and to immediately stop use of Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops because of bacterial and fungal contamination.
In a press release, the agency urged consumers to dispose of these products and immediately seek medical care if signs or symptoms of an eye infection develop, as using contaminated eye drops could result in a vision-threatening infection that could become life-threatening.
Dr. Berne’s and LightEyez eye drop products, both of which contain methylsulfonylmethane (MSM) as an active ingredient, are not approved by the FDA and illegal to market in the U.S. There are no legally marketed ophthalmic drugs that include MSM as an active ingredient, the agency said.
After recent manufacturing concerns with eye drops, the FDA conducted sampling and testing of these products, which showed both were not sterile and were contaminated with microbes. Among the contaminants identified were species of Bacillus, Exophiala, Methlyorubrum, Mycobacterium, Mycolicibacterium and Pseudomonas.
According to the release, Dr. Berne’s Whole Health Products has agreed to voluntarily recall its product, but LightEyez Limited has yet to respond or take action to protect its consumers.
At this time, the FDA is not aware of any adverse event reports related to use of either product but encourages health care providers and consumers to report concerns to the agency’s MedWatch program.
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