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The Food and Drug Administration (FDA) has issued a cautionary advisory to consumers, urging them to avoid using specific dangerous eye drops due to potential concerns. These eye drops might contain unauthorized medications not permitted for sale within the United States and could be tainted with bacteria, fungus, or a combination of both.
The FDA specifically discourages using two products: Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops. This advisory was prominently displayed on the FDA’s official website.
In its announcement, the FDA emphasized the critical nature of this issue, stating that using contaminated eye drops carries the risk of causing minor to severe infections that could compromise vision and, in extreme cases, escalate to life-threatening infections. This recall was initiated last Tuesday.
One of the key active components in these Dangerous eye drops is Methylsulfonylmethane (MSM). The FDA points out that MSM is not authorized in the United States as an appropriate eye medication and further highlights that these eye drops were improperly marketed and labeled.
An investigation by the FDA found that both brands of eye drops were contaminated with five distinct strains of bacteria. Furthermore, fungal contamination was detected in the product from Dr. Berne’s brand. This contamination violates a federal regulation that mandates eye drops to be completely sterile and safe for human use.
The FDA strongly recommends that all individuals who use Dangerous eye drops carefully inspect their products and promptly discard them if they possess any of the affected batches. According to a report from CBS affiliate KREM, avoiding purchasing these items from stores is also advisable.
Following discussions with the FDA, Dr. Berne’s officials took voluntary action on August 21st to initiate a recall of MSM drops. Subsequently, on a later date, a more comprehensive recall was announced by the company, encompassing all variations of Dr. Berne’s MSM Drops (5% Solution, 15% Solution), Dr. Berne’s Organic Castor Oil Eye Drops, and Dr. Berne’s MSM Mist 15% Solution.
The details of the incidents were not explicitly disclosed in the recall notice. However, the company acknowledged receiving two complaints related to adverse events connected to the products.
In contrast, LightEyez Limited, the other manufacturer involved, has yet to respond to the FDA’s attempts at communication. Despite attempts through email, the company has not engaged in discussions regarding the safety concerns raised by the FDA. The FDA expressed frustration, stating that “LightEyez has not responded to FDA or taken action to protect consumers” in an official statement.
It is crucial to note that using contaminated eye drops can lead to severe infections that pose a significant risk to vision and general health. Consumers are strongly advised to seek immediate medical attention if they have used either product and subsequently experience adverse reactions.
Additionally, those who encounter negative effects are encouraged to submit complaints through the FDA’s MedWatch Adverse Event Reporting program.