In clinical trials the side effects of policosanol were comparable to a placebo. In all controlled studies, policosanol has exerted no negative effect of any clinical or laboratory parameter. Following is a list of the side effects of policosanol, that although rare, have been reported:
Policosanol administered for short or long-term in patients over the age of 60 years with hypercholesterolemia has been effective, safe and nearly free of side effects.
In older adults policosanol has a similar efficacy profile to that observed in patients below 60 years old. Table 3 summarizes the main results obtained at months 6 and 12 in a long-term study performed in elderly patients.
Of particular importance in this population is the fact that no drug-related adverse side effects of policosanol have been shown. Elderly patients are at risk for such problems due to impaired renal and hepatic clearance as well as a high coexistence of concomitant diseases and of medications consumption are present.
The withdrawal rate for policosanol in short and long-term clinical studies was comparable or even lesser than that of placebo; only 0.2 % policosanol-patients withdrew before conclusion of the study as a result of policosanol side effects, compared with 0.6 % of placebo patients.
Comparative studies have shown a dropout rate due to side effects of policosanol of 0.9% compared with a 4.4% rate for those treated with other lipid-lowering drugs (e.g., statins, fibrates, probucol, and acipimox).
In a large post marketing surveillance study, the side effects of policosanol were assessed in 27,879 patients (17,225 patients for two years and 10,654 patients for four years). All of the patients were treated for at least one month. During the study only 86 patients ( 0.31%) reported adverse effects, the most frequent of which was weight loss.
A single dose (1,000 mg/day) as much as 50 times the maximum recommended dose (20 mg/day) administered to healthy volunteers produced no adverse reaction, hence no over dosage symptoms have been detected.
Animal studies demonstrate the policosanol is virtually side effect free and non-toxic as the oral LD50 in rats, mice, rabbits and dogs was > 5 000 mg/kg. Body weight gain, behavioral assays, as well as biochemical and hematological determinations in surviving animals at the end of the test (14 days) did not reveal differences between treated and control groups. Moreover, weight organ analysis and histopathological study did not reveal differences between groups.
The effects of successive dosage increases of policosanol administered orally to Macaca arctoides monkeys demonstrated that even the highest dose administered (500 mg/kg) Policosanol was tolerated.
Similar results have been shown toxicity models in rats, dogs, and monkeys. Policosanol did not produce any adverse side effects on fertility and reproduction in animal studies, nor has it exerted any mutagenic or carcinogenic effects.
Specifically, policosanol administered orally up to 500 and 1000 mg/kg did not produce embryotoxic nor teratogenic effects in rats or rabbits and a multigenerational study did not show any toxicity. In other words there were no side effects of policosanol.Pregnancy
Although policosanol neither induced teratogenic effects in rats or rabbits nor affected rat fertility and reproduction, the treatment is not allowed to use in pregnant women. The reason for this restriction is that cholesterol and associated metabolic products are required for an adequate fetal development. Since hypercholesterolemia and atherosclerosis are chronic diseases, the suspension of lipid-lowering therapy for 9 months cannot be considered as an additional coronary risk factor.Lactation
It is not known whether the product or some active metabolite is excreted via the human milk during nursing, therefore policosanol therapy should be discontinued during lactation.Pediatric use
Efficacy, safety of policosanol side effects in children has not been well established. Thus, treatment of children with policosanol is not recommended at the present.
In a policosanol online comparison study conducted by ConsumerLab four of seven policosanol products tested contained only 23% to 78% of the amount listed on the label.
The original policosanol comparison studies were conducted with policosanol derived from sugar cane. It's wise to avoid policosanol made with bees wax, rice wax or other plant waxes as many are not as effective as the sugar cane formulas.
The University of Kansas Hospital "Natural Pharmacist" website reports, "There is reason for concern that policosanol products made with bees wax may not be effective."
If quality is important to you be certain that the manufacturer of the supplement meets the Good Manufacturing Practices standards. This insures you that what you see on the label is actually in the bottle!
For many years Vital Life Nutritionals Policosanol Extra Strength supplements have been our best selling solution to improving cholesterol.
We only recommend the best heart supplements that we can find...ones that we and/or our family and friends personally use. This will assure that you don't have unwanted sided effects of poor policosanol formulas.
Vital Life Nutritionals are manufactured by a family owned and operated nutritional company celebrating 90 years of promoting natural health and wellness.
Vital Life Nutritionals Policosanol is extracted from sugar cane and is the same formula used in the clinical research studies.
Only the finest ingredients are used and you never have to worry about how fresh our products are as each container has a user-friendly Best By date.
Our products meet stringent FDA regulations. This is noteworthy, as most vitamin, mineral and herbal products do not have the oversight of the FDA.
All Vital Life Nutritional products have received the highest rating in the GMP (Good Manufacturing Practices) program.
You are guaranteed that what is on the label is inside the bottle. A large number of supplements do not meet this common sense test.
Not only is our product superior but out pricing is excellent. Since we do not spend large sums for advertising the Vital Life Nutritionals brand we pass the savings along to you!
If you don't get the results you expect from any of our products (which is rare) I'll give you a no hassle refund. You have the Millen's Personal Money Back Guarantee of Satisfaction!
We are Independent Business Owners who have a powerful incentive to keep you satisfied. Our reputation depends on it!
"My cholesterol was 397 and my doctor wanted to put me on Lipitor but I was afraid of the side effects. Gene gave me the research information on policosanol for my doctor to review and although he was somewhat skeptical he gave me the go ahead to give it a try.
When I got my first follow up test after 8 weeks total cholesterol had dropped to 240. But the best news is that my HDL cholesterol was up which improved my ratio from 7 to 4.3 which is very good.
I am elated and my doctor was pleased and I think a little bit surprised. He said "Keep on doing what you're doing." Edith
"When the results of my lipid panel came back in the spring of 2001, my triglycerides were sky high (1723) and my HDL so low (8) that I was frightened enough to try any solution the doctor suggested.
"A combination of a low-fat, low-carbohydrate diet, exercise and the use of high doses of niacin, brought the triglycerides down to a reasonable level; however, nothing seemed to budge the low HDL level to much above 18.
"When we moved out of state, my new doctor insisted that I try a combination of niacin and simvastatin to address what he thought were "unacceptable" numbers. In 2010 I finally caved and agreed to the statin combo drug.
Within a year I was unable to walk up and down stairs and couldn't lift myself from a sitting position without holding on to something.
"I immediately stopped the statin/niacin (against the doctor's advice), and I began in earnest scouring the internet for alternative solutions to what for me had been harmful pharmaceutical drugs.
"How fortunate for me that I found the Millen's Vital Heart Health for Life site. I ordered policosanol and within six months my HDL began improving. My last test, three months ago showed my HDL at 36, not ideal I realize, but for me the best it has ever been. Triglycerides and LDL were also within normal range, and my total cholesterol was 180.
"I am so very thankful that Gene and Bernie Millen continue to offer what I consider life-saving advice and products for those of us who are desperately searching for alternatives to the "traditional" drugs prescribed by most physicians today.
By: Janelle Carey, Savoy, Illinois
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