More on unapproved and possibly dangerous eye drops.

Among others - see below

FDA warns consumers of contaminated copycat eye drops

https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-contaminated-copycat-eye-drops?fbclid=IwAR085_VOsxm-9x0CtykAzUJF2Fb4Rn2nQzBFAd7HYsdwc6EBKu31z9hy_jI_aem_AfyHpReFyoRIaWRypfQKaucUi2WHDOhHkA7HxmLNfxqe1dwwFHXGJmlWgjMWkFb2a-A

“The (US)FDA is warning consumers not to purchase or use South Moon, Rebright or FivFivGo eye drops because of the potential risk of eye infection.

These are copycat eye drop products that consumers can easily mistake for Bausch + Lomb’s Lumify brand eye drops, an over-the-counter product approved for redness relief.”
While most of you know my stance on the “eye whitening” eye drops like Lumify (as well as some Visine, Clear Eyes and others advertising to “get the red out”) -

I posted on this topic here: https://www.eyethera.com/blog/can-i-use-eye-whiteners-like-visine-or-lumify-when-my-eyes-get-red?rq=lumify

They go on to say “South Moon, Rebright and FivFivGo eye drops are unapproved drugs and should not be available for sale in the U.S. They claim to treat eye conditions such as glaucoma, which is treated with prescription drugs or surgery.

Patients who have signs or symptoms of an eye infection should talk to their health care provider or seek medical care immediately. FDA recommends consumers properly discard these products.”

Of particular concern, is how close the packaging was made to copy the Bausch and Lomb Lumify product:

“Comparison of authentic Lumify with copycat products

The South Moon, Rebright and FivFivGo photos are examples of the images that appear on various websites. Some of these copycat products may be falsely labeled with “Bausch + Lomb” at the top of the packaging. The actual products may look different.”

Of potentially equal or greater concern (with Halloween around the corner) is this statement by the American Academy of Ophthalmology (AAO): “What Ophthalmologists Want You to Know About Eye Color-Changing Drops

What NOT to do for Halloween (or any other time of the year)!

“The American Academy of Ophthalmology says popular products making the rounds on social media are unproven, unregulated, and potentially dangerous

SAN FRANCISCO, Calif. — The American Academy of Ophthalmology is sounding the alarm on over-the-counter eye drops advertised as eye color-changing solutions. These products are not FDA approved, have not been tested for safety or efficacy, and could potentially damage the eyes.

“Consumers seeing these products on TikTok or elsewhere online need to know that they are not FDA approved,” said JoAnn A. Giaconi, MD, clinical spokesperson for the American Academy of Ophthalmology. “The ads show dramatic before-and-after shots and vague information on how the drops actually work to change eye color. 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 Current Good Manufacturing Practice regulations were followed during production. Unregulated manufacturing facility conditions can lead to contaminated products that can cause dangerous eye infections.

Potential safety risks of using unregulated eye drops include:

• Inflammation

• Infection

• Light sensitivity

• Increased eye pressure or glaucoma

• Permanent vision loss

Manufacturers claim that the drops include an ingredient that adjusts natural levels of melanin in the iris, the colored part of the eye. But there is no evidence that the formula can target the iris pigment. And if the drops did destroy the pigmented cells in the iris, it could potentially harm the eye, causing light sensitivity, eye inflammation, and eventually vision loss. It’s also unclear how other parts of the eye that rely on melanin to function properly, such as the retina, would react to this ingredient.

“Social media and the internet are full of potentially dangerous 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,” Dr. Giaconi said. “You’re putting yourself at risk for painful eye conditions or even blindness.”

The safest way to change eye color is with colored contact lenses, but only if the lenses are prescribed, dispensed, and fitted by a qualified eye health professional.

For more information about eye health and how to protect your eyes, visit the Academy’s EyeSmart website.”

To schedule an appointment with Dr. Jaccoma, call Excellent Vision at either of these two dry eye offices:

(1) 155 Griffin Rd, Portsmouth, NH 03801 (603) 574-2020

(2) 3 Woodland Rd, STE 112 Stoneham, MA 02180 (near Boston) (781) 321-6463

Also note that past topics I’ve posted on can be easily found by using the “Search Bar” in the blue gauze “mask” on the woman at the top of the Blog Page.