On March 17, the U.S. Food & Drug Administration (FDA) held a joint meeting between the Ophthalmic Device Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee to discuss the apparent increases in misuse-related adverse events reported with hydrogen peroxide care systems based on a review over 2015 and 2016. The data presented to the panels indicated a total of 370 reports since 2007, with about half occurring in 2015 and 2016.
How Serious Is the Risk?
Of the 370 incidents, 45% of patients reported accidental exposure to hydrogen peroxide solution, nearly 29% admitting to failing to follow the neutralization step, and 10% admitted purchasing the wrong product. It was pointed out that while many misuse incidents are not reported, the results are probably representative of the types of patient experiences. Even panel members who use peroxide systems for lens care reported that they had had misuse experiences that were unreported.
The general panel discussion indicated that while peroxide system misuse events were underreported, they were relatively rare. Also, while ocular exposure to hydrogen peroxide is painful, the long-term clinical outcomes were relatively minor; 57% reported burning sensation, 50% reported chemical eye burns, and 21% reported hyperemia, superficial punctate keratitis, injection, or epithelial erosion, according to the FDA. Nearly 90% either didn’t report on the recovery or recovered from the insult. The general opinion was that most exposures resolve without sequelae.
In spite of this and the relatively low frequency of these misuse events, it does raise cause for concern. The objective was to discuss additional measures to mitigate the potential risk of these exposures.
Several questions were posed to, and discussed among, the panel members related to current labeling for peroxide-based care products, strategies to help prevent mistaken purchase of these products, recommendations for reducing misuse once purchased, and improving compliance to instructions.
It was agreed that simplifying or reducing the text and using graphics would help better communicate the warnings. Panel members believed that using focus groups and similar approaches to test the process was important. They noted that some products use the red tip and cap, while others do not. It was decided that having a consistent approach is important going forward.
The FDA indicated that it provides guidance on the labeling but does not review the final label, particularly with the generic entries to this market. The industry stated its willingness to work on labeling changes with the FDA.
Panel members stated that techniques such as a red banner on both cartons and bottles was an important step. This, combined with appropriate warnings, was thought to be important, but there was concern about restrictions to access to this highly effective lens care modality.
There was considerable discussion about redesigning the bottle to differentiate it from multipurpose solutions and saline, but the industry indicated that a “generic” package was unlikely to be agreed upon.
Redesigning the system so that the peroxide bottle and lens case could be used together was also discussed. Manufacturers indicated that such systems are under consideration.
Overall, the critical takeaway was that practitioners can do a better job in communicating with patients, but more extensive measures are not needed given the paucity of data to indicate a significant health risk. Panel members stated that requiring an educational campaign on this issue—which does not result in adverse sequelae—could detract from other efforts demanding the attention of patients and practitioners to deal with general compliance issues that do have potential for lasting ocular effects. CLS