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Preservision side effects: Preservision Areds – Side Effects, Interactions, Uses, Dosage, Warnings

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Should I Be Taking PreserVision for Macular Degeneration? « Cynthia J. Mackay, M. D., Ophthalmologist

Q: What is PreserVision?

PreserVision (which was originally called “Ocuvite”) is a pill made by Bausch and Lomb. It contains four dietary supplements: beta carotene, vitamins E and C, and zinc. These supplements are all in megadoses, up to 15 times greater than the recommended daily intake. Bausch and Lomb instructs people to take these pills twice a day, so patients who take it are taking up to 30 times the recommended daily dose of these four supplements.

Q. Who takes PreserVision, and why?

PreserVision is being taken by millions of elderly people, worldwide, who think that it will keep them from losing their sight to Age-related Macular Degeneration (AMD).

Q: What is macular degeneration?

AMD is a hereditary eye disease that destroys the area in the center of the retina, the macula. The macula allows you to see details. It is the number one cause of legal blindness in people over 65 in the US. One out of every three people over 65 will eventually develop macular degeneration.

Q:  What is the evidence that these 4 dietary supplements might help patients who have macular degeneration?

The “evidence” comes from study called the AREDS (Age Related Eye Disease Study), which studied the effect of these four supplements. It was published in 2001 in a scientific journal, Archives of Ophthalmology.

The paper does not explain why the researchers chose these 4 supplements. They seem to have chosen them arbitrarily. There was no scientific rational for this study. Nobody understands why they chose them. It has been shown that diets rich in fruits and vegetables protect people against AMD, but we have no idea which of the thousands of different compounds in fruits and vegetables causes this beneficial effect.

Q: Were there any financial conflicts of interest in this study?

The Principal Investigator and Study Chairman of the AREDS Study, Dr. Frederick Ferris, has the patent to this drug. The AREDS study was financed partly by Storz, which is now part of Bausch and Lomb, the company that manufactures these pills.

Q: What was the design of this study?

Three different groups of patients were studied. One group had mild AMD, one had moderate (intermediate) AMD, and one had intermediate AMD in one eye and advanced AMD in the other. Some patients were given the drug, and some were given a placebo. After several years, the patients who got the drug were studied to see if the drug was effective in preventing: 1) the progression of their AMD; 2) vision loss.

Q. What were the results of this study?

The results of the study were negative. The drug had no beneficial effect on vision, and it did not stop the progression of AMD, in any of these three groups of patients.

Q: So why does anybody think these drugs work?

A. After the study was completed, the researchers went back and changed their research design. They arbitrarily threw out all patients with mild AMD from the study. This is a strange decision. Patients with mild disease are the ones who should benefit the most from this drug. Then, they changed their definition of “success”, from: “preventing vision loss and progression”, to: “preventing AMD events”.

After these manipulations, the data seemed to show that the drug prevented what they called “AMD events”, but it did so for only in one group of patients, the one who had intermediate AMD in one eye, and advanced AMD in the other. The study did NOT show that these patients had any vision benefit from taking this drug.

Q. So this study showed that only a small subgroup of AMD patients should take this drug?

The only people who supposedly “benefitted” from this drug are people who have intermediate AMD in one eye, and advanced AMD in the other. No other type of patients had any benefit. Even if a doctor accepts the results of this study, he should only recommend this drug to this small subgroup of patients.

Q. Is it standard scientific practice to change criteria after a study is over?

No. This manipulation has caused a storm of criticism in scientific meetings, and in the scientific literature. Scientists are not supposed to throw out a negative result, and then report on a small subgroup that seems to have a positive result. It does not conform to standard scientific practice. In short, the value of PreserVision has not been proven by accepted scientific methods.

Q. Is Preserveation dangerous to the patients who take it?

A. Yes.  PreserVision is very dangerous to people who take it.  The vitamins in PreserVision are at doses way above the recommended amount. Vitamins are drugs. All drugs must be taken at their proper dosages. We all know that 2 aspirin will help your headache, but that 20 aspirin can kill you. It is the same with vitamins.

All of the four supplements in this study cause serious problems:

  • beta carotene has been shown to cause lung cancer in smokers;
  • vitamin E causes lung and prostate cancer, and increases the risk of heart failure;
  • vitamin C causes kidney stones, heartburn, and diarrhea;
  • zinc doubles the risk of urinary tract problems, including enlarged prostate in men,  and incontinence in women.

Q. If Preservation is worthless and dangerous, what can a patient with early macular degeneration do to help their eyes?

  • DON’T SMOKE.
  • Eat healthy food, which means lots of fruits and vegetables. Michael Pollan correctly says, “Get your vitamins from plants, not from things made in plants”.
  • Get yearly eye exams with a retina specialist.
  • Stay away from PreserVision, and all other megadose vitamin supplements.

Secondary health risks a consideration with AREDS nutritional supplements

October 15, 2003

7 min read

Nutritionists say more research is needed to determine the systemic health effects of taking high levels of beta-carotene, zinc and vitamin E.




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The Age-Related Eye Disease Study, published in 2001, was not only the longest study of age-related macular degeneration, but it also broke ground in the research on the effects of vitamin and mineral supplementation on ocular disease.

While there have been few reports of complications resulting from the regimens evaluated during the 10-year AREDS, the long-term systemic effects of taking high levels of vitamin E, beta-carotene and zinc have yet to be determined conclusively, according to Frederick L. Ferris, MD, lead AREDS investigator.

Dr. Ferris said that the general medical literature on vitamin and mineral supplementation is confusing and often contradicts the AREDS results. He advised ophthalmologists to weigh the patient’s individual risk of developing advanced AMD against the risk of adverse effects from supplements.

“We’re trying to balance apparently low-risk complications with possible benefits,” Dr. Ferris said. “These benefits are differential depending on where you are in the spectrum of age-related macular degeneration.”

Methodology

The AREDS, a National Eye Institute-sponsored 10-year study, included 3,640 AMD patients at 11 centers across the United States.

In the study, patients at high risk of developing advanced AMD lowered their risk of progression of the disease by about 25% by taking a daily combination of 500 mg of vitamin C, 400 IU of vitamin E, 15 mg of beta-carotene, 80 mg of zinc and 2 mg of cupric oxide.

The AREDS data reported in 2001 were based on a 5-year median length follow-up, and 6.5-year follow-up data were reported at this year’s Association for Research in Vision and Ophthalmology meeting. When compared to that of the placebo group, the age- and gender-adjusted mortality rates for the groups taking either the antioxidant plus zinc, the zinc-only or the antioxidant-only formulations continue to show low risk due to supplementation.

Yet some nutritionists caution that the AREDS formula, which is recommended indefinitely for patients with the highest risk of developing advanced AMD, may cause health risks in some patients.

The risks are highest for smokers, patients with a history of stroke and patients on blood thinners, according to nutritionists interviewed by Ocular Surgery News. Other data suggest that the regimen may also produce genitourinary effects and anemia.

Smokers

In the past decade, studies have linked lung cancer to smoking and beta-carotene, a precursor to vitamin A that is converted inside the body.

In 1996, the Beta-Carotene and Retinol Efficacy Trial found that smokers, former smokers and workers exposed to asbestos who took a combination of 30 mg of beta-carotene and 25,000 IU of retinol (vitamin A) had a 28% greater risk of lung cancer after 4 years. It should be noted that the AREDS supplement formulation contained only half the 30-mg dosage of beta-carotene in this 1996 study, and there was no retinol in the AREDS formulation.

“People who are smokers should probably be very, very cautious” about taking the AREDS formula chronically, according to John W. Erdman, PhD, a professor of food science and human nutrition at the University of Illinois, Urbana. “Of course, smokers have a much higher risk of AMD.”

Dr. Ferris noted that 9% of the AREDS population consisted of smokers, but the incidence of lung cancer was too small to draw any conclusions about relative risk.

“What I tell my smoking patients is that if they’re worried about lung cancer, it’s 70 times more effective to stop smoking than to stop beta-carotene,” Dr. Ferris said. “However, in general, we don’t recommend that smokers take this formulation until they’ve stopped smoking for at least a year.”

Dr. Ferris noted that it is possible to approximate the AREDS formulation minus beta-carotene by taking a combination of the other recommended vitamins and minerals. There is no prospective controlled data, however, measuring the effect of such combinations on AMD progression.

Upper limit guidelines

Beta-carotene supplementation does not pose a risk to nonsmokers, according to Diane Feskanich, ScD, who has studied the changing nutritional needs of aging men and women at Harvard University’s Channing Laboratory.

She said that the Institute of Medicine of the National Academies did not set an upper limit on beta-carotene consumption because there is “no science” indicating that high levels could pose a risk to nonsmokers. (Beta-carotene is different from the retinol form of vitamin A, which can cause a decrease in bone density at high levels, according to Dr. Feskanich’s research.)

The Institute of Medicine established a committee in 1998 to determine the upper limits for vitamins and minerals. While the levels of vitamins C and E in the AREDS formula conform to the upper limit guidelines, the level of zinc is double the upper limit determined by the committee.

“Zinc is a nutrient that’s been studied for a long time, but we really don’t know on the everyday level what long-term consumption will do,” said Robert J. Cousins, PhD, a professor of nutrition at the University of Florida, Gainesville. “The macular degeneration study (AREDS) is probably one of the longer zinc supplement trials that’s ever been run.”

Complications from zinc

One of the few documented side effects to taking zinc is anemia, Dr. Cousins said. This risk can be managed if patients increase the amount of copper in their diets because the two minerals compete for absorption, he said.

Dr. Ferris said that the AREDS researchers conducted yearly hematocrit testing on all participants, and while there was an increased risk of reported anemia in the participants taking zinc, there were no differences in hematocrit levels. He attributes this finding to the addition of copper to the study formulation. However, researchers did see an increased incidence of genitourinary complications, he said.

“This sounds vague, but it’s vague because it only becomes statistically significant if you pool all of the problems together, all of the reasons people might go to the hospital for genitourinary problems,” he said. “There is some biologic plausibility to the fact that maybe this would increase (genitourinary) problems because … there is a high concentration of zinc in the prostate.”

Dr. Ferris also said that he would advise patients who are taking anticoagulants such as Coumadin (warafin sodium, DuPont) to avoid high levels of vitamin E.

Vitamin E causes red blood cells to become fragile and at high levels will increase the risk of hemorrhagic stroke, according to Dr. Erdman. While the overall risk of stroke is small, he said, risk could be increased by as much as 45% in patients taking vitamin E.

Supplements on the market

Bausch & Lomb collaborated with the NEI on developing the AREDS formula and was the sole corporate sponsor of the AREDS trial. The formula, which Bausch & Lomb markets under the trade name Ocuvite PreserVision, was the only vitamin and mineral formulation tested in the trial.

“The most meaningful difference between the high-potency antioxidant and zinc formulation used in the AREDS trial and other nutritional supplements is that no other supplement has ever been tested or evaluated in such a large, well-controlled clinical trial,” said Stephen P. Bartels, PhD, vice president of pharmaceuticals new product development at Bausch & Lomb. He said that in addition to PreserVision, Bausch & Lomb markets the Ocuvite line of eye health vitamins, including Ocuvite Lutein, which contains 6 mg of lutein per tablet with no beta-carotene.

Since the release of the AREDS results, a number of other pharmaceutical companies have developed supplements based on the study formulation. A daily dose of Bausch & Lomb’s Ocuvite PreserVision or Alcon’s ICaps contains 28,640 IU of beta-carotene, 400 IU of vitamin E and 69. 6 mg of zinc.

Suzie DeMent, a spokeswoman for Alcon, said that the company believes that AREDS demonstrated the benefit of this combination of vitamins and minerals with little observed side effects for a disease with no current available treatment. Alcon offers an ICaps AREDS formula as well as another formula containing lutein and zeaxanthin, natural pigments also thought to be important in the age-related disease process, she said. The ICaps lutein and zeaxanthin formulation contains a lower level of beta-carotene, amounting to 6,600 IU, Ms. DeMent said.

ScienceBased Health also offers three MacularProtect formulations, including one that is appropriate for smokers, according to the company. At 2,500 IU, MacularProtect Plus contains 90% less beta-carotene than the company’s other two products. All three formulations contain 400 IU of vitamin E and 80 mg of zinc.

Penny Edwards, MPH, CNS, a nutrition scientist for ScienceBased Health, said that many of the potential adverse effects associated with zinc are prevented by the addition of copper, and for those with AMD the demonstrated benefits of high-dose zinc surpass any theoretical downsides.

She added, however, that the nutrients might interact with or affect the absorption of certain antibiotics, such as quinolones, taken concomitantly.

Careful monitoring

“We feel that high-dose supplementation really needs to be administered by and monitored by a physician,” Ms. Edwards said. “We encourage eye care practitioners to communicate with a patient’s primary care doctor.”

ScienceBased Health offers eye care practitioners a letter that they can send to a patient’s primary care physician, alerting him or her about the benefits and possible side effects from the supplements, she said.

Dr. Ferris emphasized that the therapy has the most benefit for patients who have already lost vision in one eye and are at the greatest risk of developing advanced AMD in their fellow eye. “So for them, it would seem to me, that the risks of supplements are well outweighed by the benefits,” he said.

Source: Information supplied by the investigating companies.

For Your Information:

  • Stephen P. Bartels, PhD, can be reached at 1400 N. Goodman St., Rochester, NY 14609; (585) 338-5399; e-mail: [email protected]
  • Robert J. Cousins, PhD, can be reached at 201A Food Science and Human Nutrition Building, PO Box 110370, Gainesville, FL 32611; (352) 392-2133; e-mail: [email protected]
  • John W. Erdman, PhD, can be reached at 449 Bevier Hall, 905 South Goodwin Ave., Urbana, IL 61081; (217) 333-2527; fax: (217) 333-9368; e-mail: [email protected]
  • Frederick L. Ferris, MD, can be reached at the National Eye Institute, 31 Center Drive, MSC 2510 Building 31, Room 6A52, Bethesda, MD 20892; (301) 496-6583; fax: (301) 496-2297; e-mail: [email protected]
  • Diane Feskanich, ScD, can be reached at Channing Laboratory, Harvard Medical School, 181 Longwood Ave., Boston, MA 02115; (617) 525-0343; e-mail: [email protected]
  • Alcon Laboratories, manufacturer of ICaps, can be reached at 6201 South Freeway, Fort Worth, TX 76134; (800) 862-5266; fax: (817) 241-0677; Web site: www. alconlabs.com.
  • Bausch & Lomb, manufacturer of Ocuvite PreserVision, can be reached at 1400 N. Goodman St., Rochester, NY 14609; (585) 338-5212; fax: (585) 338-0898; Web site: www.bausch.com.
  • ScienceBased Health, manufacturer of the MacularProtect product line, can be reached at 3579 Highway 50 East, Carson City, NV 89701; (888) 433-4726; fax: (888) 433-6726; Web site: www.sciencebasedhealth.com.

References:

  • Age-Related Eye Disease Study Research Group. A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta-carotene and zinc for age-related macular degeneration and vision loss. AREDS Report No. 8. Arch Ophthalmol. 2001;119:1417-1436.
  • Supplementation with antioxidants, zinc may delay AMD progression. Ocular Surgery News. November 15, 2001.
  • Omenn GS, Goodman GE, et al. Effects of a combination of beta carotene and vitamin A on lung cancer and cardiovascular disease. N Engl J Med. 1996;334:1150-1155.
  • Virtamo J, Pietinen P, et al. Incidence of cancer and mortality following alpha-tocopherol and beta-carotene supplementation: a postintervention follow-up. JAMA. 2003;290:476-485.




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PreserVision Lutein | Side Effects

What is Preservision Lutein  |   Side effects   |   Who is it for?   |   Is it safe?   |   Ingredients   |   Customer Case Study


What is PreserVision Lutein?

In the human eye, the retina, and in particular its anatomical component the macula, is essential in enabling you to see clear sharp images. , The retina is a light sensitive layer of tissue at the back of the eyeball. As we get older, our natural defense mechanisms are weakened. This means that we are less able t protect susceptible tissues, such as the retina, against the excess of the many naturally occurring, but harmful oxidizing agents, eg free radicals.

Other factors, such as smoking, pollution, exposure to intense light, and inadequate diet, may also contribute to increasing the production of these harmful agents.

This PreserVision formulation contains vitamin E and the minerals zinc and copper which help to protect cells from oxidative stress. Zinc acts as a co-factor in several enzymatic pathways which contributes to the maintenance of normal vision.

Vitamin C contributes to the reduction of tiredness and fatigue. It is found naturally in foods such as citrus and soft fruits, leafy green vegetables and potatoes.
 

What are PreserVision Lutein Side Effects?

reserVision Luetin formulation can, like any food supplement, very occasionally cause gastronintestinal discomfort.

Who is PreserVision Lutein for?

Caring for vision becomes increasingly critical with age. Studies have shown that eating a healthy, balanced diet is important for your health, yet we know it is not always possible to eat a balanced diet. Pregnancy: This product is not suitable for pregnant women.
 

Is PreserVision Lutein Safe?

Food supplements should not be used as a substitute for a varied diet. Adults: 2 soft gels per day with a full glass of water and during meals. Do not exceed recommended intake.

PreserVision Lutein Ingredients

Vitamin C (as ascorbic acid), Vitamin E (as DL-alpha tocopheryl acetate), Gelatin, Glycerin, Soybean Oil, Zinc Oxide, Lutein (as Lutein suspended in corn oil), Soy Lecithin, Yellow Beeswax, Silicon Dioxide (anti-caking agent), Cupric oxide. Colours: Titanium dioxide (E171), Allura Red AC (E129), Brilliant Blue FCF (E133).

CUSTOMER PRESERVISION CASE STUDIES ★★★★★

Case Study: Simon’s Experience with Preservation Lutein

Simon has bought PreserVision Lutein for his father who suffers from AMD. AMD is normally an age-related around 50-60 year old’s that affects the middle…

Does Preservision Areds 2 have side effects?

Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Very upset stomach or throwing up.

Is it safe to take PreserVision? A. Yes. PreserVision is very dangerous to people who take it. The vitamins in PreserVision are at doses way above the recommended amount.

Should I take AREDS2?

Who should not take Preservision? – a high amount of oxalic acid in urine.
– iron metabolism disorder causing increased iron storage.
– sickle cell anemia.
– anemia from pyruvate kinase and G6PD deficiencies.
– decreased blood-clotting from low vitamin K.
– increased risk of bleeding due to clotting disorder.

What drugs interact with AREDS2? – amlodipine.
– aspirin.
– Aspirin Low Strength (aspirin)
– atorvastatin.
– CoQ10 (ubiquinone)
– Fish Oil (omega-3 polyunsaturated fatty acids)
– furosemide.
– gabapentin.

Does Preservision Areds 2 have side effects? – Additional Questions

Do doctors recommend PreserVision?

Many eye doctors now recommend the use of this combination in people with early macular degeneration.

Is PreserVision safe to take?

A. Yes. PreserVision is very dangerous to people who take it. The vitamins in PreserVision are at doses way above the recommended amount.

Does PreserVision Areds 2 have side effects?

Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Very upset stomach or throwing up.

Who should not take Areds 2?

Because the original AREDS trial established that the formulation does not benefit people with no AMD or early AMD, the AREDS2 trial was limited to people with intermediate AMD in both eyes, or intermediate AMD in one eye and advanced AMD in the other eye.

What are the side effects from Preservision?

Very upset stomach or throwing up. Severe diarrhea. Very bad constipation. Muscle weakness.

Can Areds be harmful?

Yet some nutritionists caution that the AREDS formula, which is recommended indefinitely for patients with the highest risk of developing advanced AMD, may cause health risks in some patients.

What are the side effects of Areds 2?

– Upset stomach or throwing up.
– Diarrhea.
– Constipation.

Are there any side effects to PreserVision Areds 2?

Very upset stomach or throwing up. Severe diarrhea. Very bad constipation. Muscle weakness.

Is AREDS2 safe to take?

The level of vitamin E in the AREDS 2 formula is fairly high and although in the study it was shown to be a safe dosage, additional vitamin E may lead to some unwanted side effects. One analysis found an increased risk of death at doses over 400 IU/day.

What are the side effects of PreserVision?

Very upset stomach or throwing up. Severe diarrhea. Very bad constipation. Muscle weakness.

Are there any side effects to Preservision Areds 2?

Very upset stomach or throwing up. Severe diarrhea. Very bad constipation. Muscle weakness.

What is the best supplement for eyesight?

– Lutein and zeaxanthin. Lutein and Zeaxanthin are carotenoids.
– Zinc. Also found naturally in your eyes, zinc is a powerful antioxidant that protects against cell damage.
– Vitamin B1 (thiamine) Vitamin B1 is essential for the health of your eyes.
– Omega-3 fatty acids.
– Vitamin C.

Does Areds 2 really work?

Currently the AREDS and AREDS2 formulas are the only available treatments proven to be effective for intermediate-to-severe dry AMD. Dozens of “eye vitamins” and “ocular supplements” containing these ingredients have been marketed for AMD and eye health in recent decades.

Does PreserVision really help your eyes?

Does PreserVision really help your eyes?

How good is PreserVision?

What are the side effects of PreserVision Areds 2?

Very upset stomach or throwing up. Severe diarrhea. Very bad constipation. Muscle weakness.

PreserVision Eye Vitamin & Mineral Supplements : Bausch + Lomb

PreserVision AREDS and AREDS 2 formulas are based on the landmark, independent Age-Related Eye Disease
Studies (AREDS and AREDS2).

 

Visit PreserVision.com to learn more:

PreserVision Eye Vitamin AREDS 2 Formula

PreserVision AREDS 2 Formula builds on the original, clinically proven PreserVision
AREDS Formula, with lutein and zeaxanthin replacing beta-carotene based on evidence from the National
Eye Institute’s Age-Related Eye Disease Study 2 (AREDS2).

PreserVision Eye Vitamin AREDS 2 Formula Chewables

The PreserVision AREDS 2 Formula in a convenient, great-tasting, mixed berry chewable.

PreserVision AREDS 2 Formula + Multivitamin

A convenient 2-in-1 formula that combines the benefits of PreserVision AREDS 2 Formula plus
essential vitamins and nutrients found in daily multivitamins* making it simpler for your patients to
take their supplements by reducing the number of pills taken each day.

PreserVision Eye Vitamin AREDS Formula Soft Gels

This 2 per day soft gel format is based on the original Bausch +
Lomb PreserVision
 eye vitamin AREDS Formula (tablets) that was tested and proven
effective in the National Eye Institute’s Age-Related Eye Disease Study (AREDS)*.

PreserVision Eye Vitamin Lutein Formula Soft Gels

Convenient to take, 2 per day soft gel format, AREDS-based formula that replaces beta-carotene with
lutein. For your patients who should avoid beta-carotene, such as current or former smokers.

PreserVision Eye Vitamin AREDS Formula Tablets

The original Bausch + Lomb PreserVision eye vitamin AREDS Formula—the actual supplement tested
and proven effective in the National Eye Institute’s Age-Related Eye Disease Study (AREDS)*. 4 tablets
per day format.

 

*These statements have not
been evaluated by the Food and Drug Administration. This product is not intended to diagnose,
treat, cure or prevent any disease.

 

 

AREDS and AREDS2 are registered trademarks of the United States Department of Health and Human Services (HHS).

† Based on the AREDS and AREDS2 clinical studies.

PVN.0069.USA.21

Side Effects Of Preservision Areds 2

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PreserVision AREDS 2 Side Effects: Common, Severe, Long

4 hours ago PreserVision AREDS 2 Side Effects. Generic name: multivitamin with minerals Note: This document contains side effect information about multivitamin with minerals. Some of the dosage forms listed on this page may not apply to the brand name PreserVision AREDS 2.. Applies to multivitamin with minerals: oral tablet

Website: https://www.drugs.com/sfx/preservision-areds-2-side-effects.html