FDA Approvals

FDA warns consumers not to purchase or use certain methylsulfonylmethane (MSM) eye drops due to contamination

FDA1d ago1 min read

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.

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AI Summary

Quick Take

The FDA has issued a formal warning against the use of Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops – Eye Repair due to confirmed bacterial and fungal contamination. These unapproved ophthalmic products pose a significant risk of serious ocular infection and should be discarded immediately by any patients currently using them.

Why It Matters

This warning serves as a critical reminder of the safety gaps in the 'natural' and alternative ophthalmic market, where products often bypass the rigorous sterile manufacturing requirements mandated by the FDA. Patients frequently seek out MSM (methylsulfonylmethane) drops for various conditions without realizing they are using unapproved drugs that may lack adequate preservative systems or sterile processing. For the clinician, this highlights the necessity of screening patients for the use of niche or online-purchased eye drops, as these can be the hidden source of recalcitrant keratitis or endophthalmitis.

Key Details

The warning specifically identifies Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops – Eye Repair.
FDA laboratory testing found that the products were contaminated with bacteria, fungi, or a combination of both.
The products are considered unapproved drugs and are being marketed illegally for ophthalmic use.
The FDA is advising consumers to stop using these products immediately and to dispose of them safely.

Practice Implications

Clinicians should update their patient intake protocols to specifically ask about 'natural' or MSM-containing eye drops purchased online. If a patient presents with unexplained ocular inflammation or signs of infection while using these brands, the product should be confiscated or discarded, and the patient should be monitored closely for infectious keratitis. Any adverse events should be reported to the FDA’s MedWatch program to assist in regulatory tracking.

Who's Affected

OptometristsOphthalmologistsCornea SpecialistsPractice Owners

What's Next

Expect further regulatory scrutiny of manufacturers selling unapproved MSM ophthalmic solutions. Practitioners should watch for formal recall notices and be prepared to manage potential infections in patients who have used these contaminated batches.

Evidence StrengthStrong

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