FDA Panel Backs Packaging, Label Changes for Hydrogen Peroxide-Based Contact Lens Solutions

Troy Brown, RN

March 20, 2017

The US Food and Drug Administration's (FDA's) Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee largely agreed – without voting – that the packaging and labels of contact lens cleaning solutions that contain hydrogen peroxide should be changed to make them more easily distinguishable from those that do not contain hydrogen peroxide.

Hydrogen peroxide–containing contact lens solutions are popular, because unlike multipurpose solutions, it is not necessary to rub the lenses and rinse them to dislodge dirt before disinfecting them. In addition, hydrogen peroxide solutions contain no preservatives, making them attractive for those with allergies or who are sensitive to preservatives.

On the other hand, disinfection with a hydrogen peroxide solution must be followed by a neutralization process in order to make the lenses safe to reinsert into the eyes. Neutralization can be accomplished by placing a neutralizing tablet into the peroxide solution or rinsing with saline solution after disinfection. Some formulations of hydrogen peroxide solution come with a built-in neutralizer in the specially shaped contact lens case.

Failure to neutralize the peroxide solution or inadvertently getting the solution in one's eyes can cause excruciating pain and temporary corneal injury. Between 2007 and 2016, the FDA received 370 medical device reports related to hydrogen peroxide–based contact lens care system products.

Of those, the causes of injury were accidental use (168), failure to follow neutralization method (107), erroneous purchase (thinking they were buying a solution without hydrogen peroxide) (40), unspecified detail of misuse (19), use of expired product (15), improper care of lens case (12), and healthcare provider error (9).

Solutions Elusive

Most of the panelists agreed that the warnings and instructions on the peroxide-containing boxes are too unwieldy and difficult to understand, and consumers may be discouraged from reading them at all. One panelist held up a box with the warning literature inside, saying that if the consumer were not careful opening the box, they might miss what is inside.

Panel member James Dillard, PhD, Pennsylvania State University, State College, gave examples of good and bad warning instructions from the labels of two products. One of the instructions gave a reason for the instruction, but the other did not. The instruction that included a reason was likely to be more effective, he said.

"I absolutely agree with the suggestion for [giving] the reasoning for [taking particular steps]," panel member Susan J. Blalock, PhD, University of North Carolina, Chapel Hill, said. She agreed that providing a reason was probably going to be more effective at motivating consumers. Dr Blalock and several other panel members also took issue with the words that getting the hydrogen peroxide solution in the eyes would cause "stinging" and "burning." She felt these words were too mild to describe the intense pain patients would typically experience.

Labeling Changes Alone Will Not Solve the Problem

Labeling alone won't solve the problem, a number of speakers said. Many consumers do not read the labeling, and some labeling wraps around the container, making it difficult to understand. The fine print can also be difficult to read, particularly for those with vision problems. For these reasons, bottles of different types of contact solutions need to be different in appearance, and bottles of those that should not be instilled in the eye need to be designed in a way that makes that obvious.

"[W]e seem to be combining a number of different functions all under labeling. There's the very important alert function, and then there's the education function, and then there's a reminder function. As I look through the data that were presented to us, it seems as if probably...one of the foremost issues is really the alert function...." panel member Stephen D. McLeod, MD, University of California, San Francisco, Medical Center, said. Many patients are being educated in their clinician's office, and he said he doubted that many are deciding to switch products at the drug store.

"It seems as if really making sure that the labeling problem we're trying to solve actually addresses the alert part of the equation is really important. As far as the education goes, one would think that when the individual is in their optometrist's office or they go to their physician's office, that's when they would have the most part of the education.

"Spending a lot of time on parsing how large the text is and how small the text is and what's in it and what's not in it really seems to be placing a lot of emphasis on the education and reminder function, and I would say that it probably makes more sense to focus on the alert piece," Dr McLeod explained.

Placing more emphasis on the label about the severe pain a patient would experience if they got the product in their eye might be more helpful, he said.

Opinions were mixed about whether or not hydrogen peroxide–containing solutions should be placed on different store shelves from solutions without hydrogen peroxide, but most agreed that their sale should not be restricted to being from behind the counter at the pharmacy nor sold only at the offices of contact lens practitioners.

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