What Are the Side Effects of PreserVision AREDS?
Skin can become yellow due to the beta-carotene in PreserVision AREDS, while severe hemorrhaging is rare, according to WebMD. Venous blood clotting, blurred vision, dizziness, nausea and breast tenderness are also rare. PreserVision is a supplement containing antioxidant vitamins and minerals, according to Bausch + Lomb. PreserVision AREDS2 retains the original PreserVision formula but substitutes zeaxanthin and lutein for beta-carotene.
PreserVision AREDS contains vitamins A, C, E, zinc and copper, a combination that slows age-related macular degeneration development, explains Bausch + Lomb. The acronym refers to a 10-year study of age-related eye disease conducted by the National Eye Institute. Its results showed that patients with AMD in moderate to advanced stages who took two supplement pills each morning and two each evening with meals experienced slowed progression of the disease, which causes vision loss.
Based on the subsequent five-year study AREDS2, Bausch + Lomb replaced vitamin A, the source of beta-carotene that caused skin discoloration, with the nutrients zeaxanthin and lutein, notes the company. The dosage of PreserVision AREDS2 is one supplement soft gel each morning and one each evening with meals.
Zeaxanthin and lutein function as antioxidants in the eyes and decrease the risk of age-related macular degeneration and cataracts, according to the American Optometric Association. People normally gain these nutrients from foods such as cooked kale, collards, spinach, broccoli and eggs.
A few years back, a big clinical trial showed that certain nutritional supplements could slow the progression of macular degeneration and reduce the risk of vision loss. “There was great interest among patients,” recalled Ingrid Scott, an ophthalmologist at the Penn State College of Medicine. “This was big news.”
Age-related macular degeneration is the leading cause of severe vision impairment and blindness in older Americans. For the great majority of those who have it, there’s no effective treatment. And it generally worsens with time. “Patients with age-related macular degeneration are extremely motivated to do whatever they can,” Dr. Scott said.
The trial showed that one thing they could do was to take a specific formula of vitamins, minerals and other nutrients. Manufacturers quickly responded with a host of over-the-counter pills making a host of claims. Now, my drugstore and supermarket — and yours — have shelves of products that supposedly help people with macular degeneration and other supplements that “promote” or “maintain” or “protect” eye health.
Do they? Dr. Scott and her colleagues recently reviewed the ingredients and found reasons to proceed with caution.
First, a primer.
The clinical trial called AREDS (Age-Related Eye Disease Study), conducted at 11 medical centers around the country by the National Eye Institute, found that a supplement could reduce the risk of worsening macular degeneration and severe vision loss by 25 percent over six years. The effective formula: a high-dose combination of vitamins C and E, beta carotene and zinc oxide, with a dash of copper.
“But the benefits of the nutrients only apply to certain stages of the disease,” Dr. Scott pointed out. “The formula could slow the progression in patients with either intermediate age-related macular degeneration or with advanced macular degeneration in only one eye.”
It didn’t work for people with milder forms of the disease, or with advanced age-related macular degeneration in both eyes. It didn’t prevent people from getting the disease in the first place. It didn’t cure anybody. But it was the best doctors could offer most patients with macular degeneration, apart from lifestyle modifications like stopping smoking.
Last year, a follow-up study called AREDS 2 examined a formula without beta carotene (because it’s associated with higher lung cancer rates in smokers), replacing it with the nutrients lutein and zeaxanthin and lowering the zinc content. The revised formula worked just as well.
So you’ll find those key initials, AREDS and AREDS 2, on a number of supplements sold in stores these days. Patients with moderate macular degeneration or advanced degeneration in one eye can take either, though smokers should go with AREDS 2.
But when Dr. Scott and her fellow researchers looked carefully at the supplements’ ingredients, in a study just published in the journal Ophthalmology, they found that most best-selling products didn’t follow the proven AREDS formula.
Some contained the right ingredients but not the right doses. Some added other stuff (selenium, B vitamins, grapeseed extract) that hasn’t been shown to slow macular degeneration and might actually reduce the effectiveness of the ingredients that do work. Of the 11 supplements that market research shows were top-sellers, only four duplicated the AREDS formula.
Moreover, most manufacturers didn’t bother to point out that the AREDS results don’t pertain to everyone with macular degeneration, and that therefore some consumers won’t benefit from these products.
(You can read more on the National Eye Institute’s fact sheet and patient FAQ.)
Manufacturers can get away with this because such products aren’t considered drugs. The Food and Drug Administration doesn’t test or approve supplements. “It may surprise people to know that dietary supplements are not evaluated or regulated at all for efficacy or safety,” Dr. Scott said.
When manufacturers say products that don’t use the AREDS formulas “protect” or “support” your eyes, “these claims are very vague,” Dr. Scott said. “There’s insufficient data to support them.”
That puts the onus on health professionals to prescribe specific brands that contain the proven formulas, and on consumers to shop carefully. These supplements don’t come cheap: At my local CVS, you’d pay $26.99 for the 90-pill size of PreserVision Eye Vitamin AREDS Formula Soft Gels. Taken as directed, you’ll pay $220 or so a year — out of pocket, of course, because Medicare Part D doesn’t cover supplements. But at least that’s one of the products that duplicated the AREDS formula, Dr. Scott and her colleagues reported.
Alternatively, you could pay $19.99 for 100 tablets of ICAPS Eye Vitamin Lutein & Zeaxanthin Formula at my local supermarket. Taking four a day as recommended, you’ll spend nearly $300 a year, but you won’t get the proper formula. The researchers found that it was one of the products with amounts of AREDS ingredients lower than those used in the studies proving they work.
So I’m passing along the findings of Dr. Scott and her colleagues, which are based not on laboratory analyses, just on what the manufacturers themselves said on product websites and packages. The report didn’t include Walmart products.
These four products duplicated the AREDS or AREDS2 formulas:
- PreserVision Eye Vitamin AREDS Formula tablets
- PreserVision Eye Vitamin AREDS Formula soft gels
- PreserVision AREDS2 Formula soft gels
- ICAPS Eye Vitamin AREDS Formula
Other best-selling supplements didn’t follow the AREDS formulae, including Eye Science Macular Health Formula, several products from Ocuvite and other ICAPS formulations. They had lower doses of the proven ingredients, or included substances not shown to be effective in these large-scale clinical trials.
Valeant announced that its subsidiary Bausch + Lomb has launched PreserVision AREDS 2 Formula + Multivitamin for patients with moderate to advanced age-related macular degeneration.
The new 2-in-1 product is the first to combine the recommended AREDS 2 nutrient formula with other essential vitamins and minerals found in daily multivitamins. The formula contains the exact levels of all six clinically proven nutrients recommended by the National Eye Institute to decrease the risk of progression in patients with moderate to advanced age-related macular degeneration.
PreserVision AREDS 2 Formula + Multivitamin is beta carotene-free and contains high Vitamin D to support the needs of older adults. The formula adds on the original PreserVision AREDS formula, with lutein and zeaxanthin replacing beta-carotene based on the recent AREDS2 Study. The study was initiated in 2006 to see if the original AREDS formulation could be improved. Researchers tried adding omega-3 fatty acids as well as lutein and zeaxanthin, which belong to the same family of nutrients as beta-carotene. The data indicated that while omega-3 fatty acids had no effect on the formulation, lutein and zeaxanthin together appeared to be a safe and effective option to beta-carotene.
PreserVision AREDS 2 Formula + Multivitamin is available in cartons of 120 softgels.
For more information call (800) 553-5340 or visit PreserVision.com.
The AREDS2 Formula
The Age Related Eye Disease Study 2 (AREDS2), sponsored by the National Institutes of Health (NIH), showed that supplementation with certain micronutrients reduces by 25 percent the progression of dry AMD into the more advanced stage in which vision loss occurs. This AREDS2 formula contains:
Beta carotene, lutein and zeaxanthin are all a specific type of phytochemical (micronutrients from plants) called carotenoids, which are structurally related to vitamin A. Our bodies do not make these. Plants make them, in part to serve as antioxidants that protect them from potentially harmful sunlight. When we eat lutein and zeaxanthin, they are transported to the retina, where they are thought to protect against light-induced damage. There’s normally enough lutein and zeaxanthin in the macula, the central part of the retina, to turn this part yellow. In fact, the full name of the macula is macula lutea, which means yellow spot.
Vitamins C and E are antioxidants. Zinc also has some antioxidant properties and is needed for a number of enzymes. Copper is part of the AREDS formula because zinc supplementation can cause copper deficiency, since these two micronutrients compete with each other for absorption in the intestines.
It’s important to take the AREDS2 vitamins if your ophthalmologist recommends them, in order to decrease the risk of vision loss from AMD.
The AREDS1 formula (developed from an earlier study) contains beta carotene instead of lutein and zeaxanthin, but beta carotene can cause lung cancer in smokers and perhaps former smokers, so it has been replaced by lutein and zeaxanthin. If recommend by your ophthalmologist, be sure to purchase products that say “AREDS2 formula.”
One NIH study found that a number of vitamins marketed for eye health did not contain the nutrient amounts stated on the label. This can occur because the supplement industry is not regulated as stringently as the prescription drug industry.
The Right Formula
In contrast, some brands do contain the right nutrients at the right levels. For this reason, I recommend that you look closely at vitamin labels; be sure the label says AREDS2 formula; and check their listed vitamins against our chart, above. If you are uncertain about a specific product, ask your doctor for recommended brands that meet the AREDS2 formulation. AREDS2 products can be purchased over the counter. The dose is generally one soft gel twice a day with a meal.
What about Other Multivitamins?
The AREDS2 study participants were allowed to take a general multivitamin. The use of these vitamins did not affect the risk for AMD progression one way or the other, but they were not harmful either. In fact, the AREDS2 vitamins alone, or in combination with multivitamins, did not have adverse effects except a slightly increased risk of urinary-related hospitalizations in men. Zinc supplementation was even associated with an increased lifespan in AMD patients.
The AREDS2 vitamins are helpful for people whose retinas have a certain number of white spots called drusen, which can be seen by the ophthalmologist during a dilated eye exam. They are not recommended for people who have no or only a few drusen because these people have such a low risk of developing AMD, at least over the next 5 years.
Family members of people with macular degeneration often ask whether they should take AREDS2 vitamins or lutein/zeaxanthin. While these are safe to take over a period of at least 5 years (the duration of the AREDS2 study), it is not known whether it would be safe for a number of decades. Therefore, it is recommended that family members eat foods containing high levels of lutein and zeaxanthin rather than take the supplements. These foods also contain hundreds of other phytochemicals that are likely to be helpful. Foods such as egg yolk (go easy due to cholesterol), yellow corn, orange or yellow peppers, kale, broccoli, spinach, kiwi, grapes, zucchini, and squash have high levels of lutein and/or zeaxanthin and are thought to be protective against AMD.
- Macular Degeneration Toolkit (Helpful Information to Understand and Manage Macular Degeneration)
- Expert Information on Macular Degeneration (Articles)
- BrightFocus Chats (Audio Presentations on Macular Degeneration)
- Are You Getting What You Need from Your AREDS Supplements? (Article)
- Why is My Doctor Always Talking About “Drusen”? (Article)
- How Effective are Age-Related Macular Degeneration Treatments? (Article)
- Lutein and Zeaxanthin for Protection against Macular Degeneration (Article)