| Certain Methylsulfonylmethane (MSM) Eye Drops by Dr. Berne’s: Safety Alert – Due to Bacterial Contamination AUDIENCE: Consumer, Health Professional, Ophthalmology ISSUE: FDA is warning consumers not to purchase and to immediately stop using Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops – Eye Repair due to bacterial contamination, fungal contamination, or both. FDA conducted sampling and testing based on these products’ intended use in the eyes, and due to the industry’s recent manufacturing issues with eye drops. FDA’s testing showed the products were contaminated with microbes and were not sterile. Under the Federal Food, Drug and Cosmetic Act, eye drops must be sterile to be safe for use. The table below includes examples of specific microbes isolated from FDA testing. Dr. Berne verbally agreed on August 21, 2023, to voluntary recall the Dr. Berne’s MSM Drops 5% Solution.FDA emailed LightEyez Limited on August 21, 2023 seeking to discuss FDA’s concerns with LightEyez products distributed in the U.S. and further steps to protect consumers from using the contaminated eye drops. To date, LightEyez has not responded to FDA or taken action to protect consumers. FDA is not aware of any adverse event reports associated with use of either products at this time. BACKGROUND: The Dr. Berne’s and LightEyez eye drop products contain methylsulfonylmethane (MSM) as an active ingredient. 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. RECOMMENDATIONS: – FDA recommends consumers properly discard these products as as FDA describes. Using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection. – Patients who have signs or symptoms of an eye infection should talk to their health care professional or otherwise seek medical care immediately. |
| Health professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: – Complete and submit the report online. – Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178. Click here for more information. |