What your patients need to know about eye color-changing drops

(Image Credit: AdobeStock/Andrey Nikitin)

The American Academy of Ophthalmology is issuing a warning regarding over-the-counter eye drops that have been advertised as eye color-changing solutions.

According to an AAO news release, the drops are not FDA approved, have not been tested for safety or efficacy, and may result in damage to the eyes.¹

JoAnn A. Giaconi, MD, clinical spokesperson for the American Academy of Ophthalmology, pointed out that consumers who may see the drops used on TikTok or elsewhere online should be advised that they are not FDA approved.

“The ads show dramatic ‘before-and-after’ shots vague information on how the drops actually work to change eye color,” she said in the news release. “But here’s the reality, there’s no evidence that they do anything at all, and no evidence that they’re safe.”

Because the products are not FDA approved, they have not undergone rigorous safety and efficacy testing, and it’s unclear if the FDA’s Current Good Manufacturing Practice regulations were followed during production of the drops.²

Moreover, the Academy noted that unregulated manufacturing facility conditions can lead to contaminated products that can cause dangerous eye infections.¹

The potential safety risks of using unregulated eye drops include:

• Inflammation
• Infection
• Light sensitivity
• Increased eye pressure or glaucoma
• Permanent vision loss

The Academy noted that the dorp manufacturers claim the products include an ingredient that adjust the natural levels of melanin in the iris. However, there is no proof the formula can target the iris pigment. And if the drops did destroy the pigmented cells in the iris, it also could lead to harm to the eye, including causing light sensitivity, eye inflammation, and eventually vision loss. It also is unknown how other parts of the eye that rely in melanin to function properly, including the retina, could be impacted by the drops.

Giaconi pointed out that social media is a font of potentially hazardous eye health claims.

“Bottomline, the Academy advises the public to never put anything in the eye that isn’t made to go in the eye,” Giaconi said in the news release. “You’re putting yourself at risk for painful eye conditions or even blindness.”

The Academy also noted the safest way to change eye color is with colored contact lenses that are prescribed, dispensed, and fitted by a qualified eye health professional.¹

Patients can find additional information on eye health and protection at the Academy’s EyeSmart website.³

Reference:

1. American Academy of Ophthalmology. What Ophthalmologists Want You to Know About Eye C | Newswise. Newswise.com. Published August 27, 2024. Accessed August 28, 2024. https://d.newswise.com/articles/what-ophthalmologists-want-you-to-know-about-eye-color-changing-drops

2. US Food and Drug Administration. Facts About the Current Good Manufacturing Practices (CGMP). U.S. Food and Drug Administration. Published 2024. Accessed August 28, 2024. https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practice-cgmp#:~:text=Therefore%2C%20it%20is%20important%20that

3. Eye Health - American Academy of Ophthalmology. Aao.org. Published 2019. https://www.aao.org/eye-health