Plantago Ovata husk • Fructus Crataegus Pinnatifida • Beta-Carotene . Other Ingredients: Fructose, Aspartame, Carboxy Methyl Cellulose CMC, Glucose, Lactose, Strawberry Red.
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Below is general information about the effectiveness of the known ingredients contained in the product Fiber Hawthorn Plus. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Fiber Hawthorn Plus. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
LIKELY SAFE ...when used orally and appropriately. Beta-carotene supplements are appropriate for certain specific conditions; however, beta-carotene supplementation is not recommended for the general population (4844,6393). There is no tolerable upper intake level (UL) set for beta-carotene. However, doses as low as 20 mg/day have been associated with increased risk of lung and prostate cancer in people who smoke (1371,3359,3937,3959,6393,11786). There is also concern that taking high doses of antioxidants such as beta-carotene might do more harm than good. In several analyses of clinical studies involving smokers and healthy non-smokers, taking beta-carotene supplements alone or in combination with other antioxidants is associated with an increased risk of mortality from all causes (15305,34514,90775).
POSSIBLY UNSAFE ...when used orally in high doses or in people who smoke or have a history of asbestos exposure. Supplemental beta-carotene 20 mg daily for 5-8 years seems to increase the risk of lung cancer, prostate cancer, intracerebral hemorrhage, and cardiovascular and total mortality in people who smoke cigarettes or have a history of high-level exposure to asbestos (1371,3359,3937,3959,6393,11786,34591). There is also concern that taking high doses of antioxidants such as beta-carotene might do more harm than good in the general population. In several analyses of clinical studies involving smokers and healthy non-smokers, taking beta-carotene supplements alone or in combination with other antioxidants is associated with an increased risk of mortality from all causes (15305,34514,90775). Beta-carotene from foods does not seem to have this effect.
CHILDREN: LIKELY SAFE
when used orally and appropriately (4844).
High doses (greater than 60 mg per day) have been used with apparent safety for specific conditions such as erythropoietic protoporphyria (11793).
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately (4844,6393).
There is insufficient reliable information available about the safety of large doses of beta-carotene in pregnancy and lactation.
LIKELY SAFE ...when used orally with appropriate fluid intake (93216). Blond psyllium preparations have been safely used in doses up to 20 grams per day for up to 6 months (1376,2324,2327,6261,6262,8060,8061,8066,8423,9422) (10095,13102,22961,22962,22963,22964,22966,54260,22968,22969) (22970,22972,22973,22976,22977,22978,22979,22980,22981,22986) (22987,22988,22989,22990,22992,22993,22994,22995,22996,22998) (23402,23403,23404,23405,92198,106859). The U.S. Food and Drug Administration (FDA) requires over-the-counter medicines that contain dry or incompletely hydrated psyllium to carry a warning that they should be taken with at a least a full glass of liquid to reduce the risk of choking. This labeling also applies to foods containing psyllium that are marketed with a health claim regarding coronary heart disease (93217,93218).
POSSIBLY SAFE ...when used in eye drops. Blond psyllium mucilage has been used with apparent safety in eye drops four times daily for 6 weeks (105274). There is insufficient reliable information available about the safety of blond psyllium when used topically.
LIKELY UNSAFE ...when used orally without adequate fluid intake due to the risk for choking and gastrointestinal obstruction (93218). ...when granular dosage forms containing blond psyllium are used as over the counter (OTC) laxatives. The U.S. Food and Drug Administration (FDA) states that these granular dosage forms are not generally recognized as safe and effective as OTC laxatives due to an increased risk of choking and gastrointestinal obstruction (93219).
CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term.
Blond psyllium husk has been used with apparent safety in doses up to 12 grams daily for 4 weeks (110763).
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately (272).
POSSIBLY SAFE ...when used orally and appropriately, short-term. Hawthorn preparations in doses of up to 1800 mg daily seem to be safe when used for up to 16 weeks. Although hawthorn might be safe for long-term use, current studies have not evaluated safety past 16 weeks (8279,8280,8281,10144,17203,104689). There is insufficient reliable information available about the safety of hawthorn when used topically.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Fiber Hawthorn Plus. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Beta-carotene might decrease the beneficial effects of niacin on high-density lipoprotein (HDL) cholesterol levels.
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A combination of niacin and simvastatin (Zocor) effectively raises high-density lipoprotein (HDL) cholesterol levels in patients with coronary disease and low HDL levels. Clinical research shows that taking a combination of antioxidants (beta-carotene, vitamin C, vitamin E, and selenium) along with niacin and simvastatin attenuates this rise in HDL, specifically the HDL-2 and apolipoprotein A1 fractions, by more than 50% in patients with coronary disease (7388,11537). It is not known whether this adverse effect is due to a single antioxidant such as beta-carotene, or to the combination. It also is not known whether it will occur in other patient populations.
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Theoretically, blond psyllium might reduce the effects of carbamazepine and increase the risk for convulsions.
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Theoretically, taking blond psyllium at the same time as digoxin might reduce digoxin absorption.
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Theoretically, taking blond psyllium at the same time as ethinyl estradiol might alter levels of estradiol.
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Concurrent use of blond psyllium with ethinyl estradiol results in a slight increase in the extent of ethinyl estradiol absorption and a slower rate of absorption. However, this is unlikely to be clinically significant (12421).
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Theoretically, taking blond psyllium at the same time as lithium might reduce lithium absorption.
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Theoretically, blond psyllium might increase the therapeutic and adverse effects of metformin.
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Concurrent use of blond psyllium with metformin slows and increases metformin absorption (99433). To avoid changes in absorption, take psyllium 30-60 minutes after metformin.
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Theoretically, taking blond psyllium at the same time as olanzapine might reduce olanzapine absorption.
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The fiber in blond psyllium might decrease the absorption of olanzapine. A single case report describes a reduction in the effectiveness of olanzapine when it was taken concomitantly with an unspecified type of psyllium 3 grams orally twice daily. This effect was reversed when psyllium was stopped (106858).
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Theoretically, psyllium might increase, decrease, or have no effect on the absorption of oral drugs.
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Psyllium seems to have variable effects on drug absorption. To avoid changes in absorption, take psyllium 30-60 minutes after oral medications. Animal research shows that blond psyllium delays and increases the absorption of metformin and ethinyl estradiol (12421,99433). Conversely, case reports and animal research suggest that blond psyllium might reduce absorption of lithium, digoxin, olanzapine, and carbamazepine (12,18,272,93214,106858). Finally, some pharmacokinetic studies show that psyllium does not affect the absorption of levothyroxine or warfarin (12420,103940).
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Theoretically, hawthorn may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
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In vitro and animal research shows that hawthorn can inhibit platelet aggregation (95528,95529,95530,95531). However, its effect in humans is unclear. One observational study shows that patients taking hawthorn shortly before undergoing coronary artery bypass graft (CABG) surgery or valve replacement surgery have a 10% incidence of postoperative bleeding, compared with 1% in those who never consumed hawthorn extract (95527). However, clinical research shows that taking a specific preparation of dried hawthorn leaves and flowers (Crataesor, Soria Natural Lab) 800 mg three times daily for 15 days does not affect platelet aggregation or levels of thromboxane B2, the metabolite of thromboxane A2, in healthy humans (54664).
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Theoretically, concomitant use might cause additive effects on blood pressure and heart rate.
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Theoretically, concomitant use might cause additive coronary vasodilation and hypotensive effects.
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Theoretically, hawthorn might potentiate the effects and adverse effects of digoxin.
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Theoretically, concomitant use might cause additive coronary vasodilatory effects.
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Theoretically, concomitant use might result in additive vasodilation and hypotension.
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Hawthorn might inhibit PDE-5 and cause vasodilation (12595).
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Below is general information about the adverse effects of the known ingredients contained in the product Fiber Hawthorn Plus. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
General
...Orally, beta-carotene is well-tolerated when used in appropriate amounts.
Most Common Adverse Effects:
Orally: Belching, orange skin (temporary).
Serious Adverse Effects (Rare):
Orally: Increased cardiovascular mortality and cancer risk in smokers and other specific patient populations.
Cardiovascular ...Orally, beta-carotene 20 to 30 mg daily seems to increase cardiovascular mortality by 12% to 26% in people who smoke (2642,3949,108641). Smokers and people with a history of asbestos exposure should not use beta-carotene supplements. In males who smoke and have had a prior myocardial infarction (MI), the risk of fatal coronary heart disease increases by as much as 43% with beta-carotene 20 mg daily (3937). These adverse effects do not seem to occur in people who eat foods high in beta-carotene content (1440,2657).
Dermatologic ...High oral doses of beta-carotene in foods or supplements can cause yellow or orange skin pigmentation called carotenoderma (11786,34572,34594,91382,108641). In clinical trials, the incidence of carotenoderma has been reported to be up to 15.8% (34626).
Gastrointestinal ...Orally, beta-carotene may cause belching (34572,34594).
Ocular/Otic ...In a case report, treatment with a high dose of beta-carotene and canthaxanthin for more than 6 years resulted in the development of glistening bright yellow crystalline deposits around the maculae. This resulted in a slight decrease in visual acuity and adaptation to the dark (34641).
Oncologic ...Smokers and people with a history of asbestos exposure should not use beta-carotene supplements. Beta-carotene in doses of 20 mg per day for 5-8 years has been associated with an increased risk of lung and prostate cancer and increased total mortality in people who smoke cigarettes (21 or more daily), and in people with a history of high-level asbestos exposure (3959,6393,11303,11786,104467,108641). These adverse effects do not seem to occur in people who eat foods high in beta-carotene content (1440,2657). There is also concern that beta-carotene might increase the risk of adverse outcomes in non-smokers. In one large-scale population study, males who took a multivitamin more than 7 times per week and who also took a separate beta-carotene supplement had a significantly increased risk of developing advanced prostate cancer (15607).
Pulmonary/Respiratory ...Clinical research shows that taking beta-carotene 20 mg daily, alone or along with vitamin E 50 mg daily, increases the risk of common colds by 21% to 25% in individuals participating in heavy exercise at leisure. However, it does not appear to affect the risk of common cold in individuals who participate in heavy activity at work (34508).
Other ...Analysis of studies in smokers and non-smokers suggests that taking beta-carotene supplements alone or in combination with other antioxidants increases the risk of mortality from all causes (15305).
General
...Orally, blond psyllium is generally well tolerated.
When used as eye drops, blond psyllium seems to be well tolerated.
Most Common Adverse Effects:
Oral: Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, and nausea.
Serious Adverse Effects (Rare):
Oral: Bowel obstruction, esophageal obstruction.
Gastrointestinal ...Orally, blond psyllium can cause transient flatulence, abdominal pain, diarrhea, constipation, dyspepsia, and nausea (1376). Starting with a low dose and slowly titrating to the desired dose can often minimize gastrointestinal side effects. There is some concern that blond psyllium can cause esophageal or bowel obstruction when consumed without water or in patients with swallowing disorders (604,8080,8081,110760). Tell patients to consume plenty of water when taking blond psyllium. Suggest at least 240 mL of fluid for every 3.5-5 grams of seed husk or 7 grams of seed (1376,8080,8081).
Musculoskeletal ...Orally, backache has been reported with the use of psyllium (1376).
Neurologic/CNS ...Orally, headache has been reported with the use of psyllium (1376).
Ocular/Otic ...Ophthalmically, blurred vision or burning haven been reported rarely in patients using eye drops containing blond psyllium mucilage (105274).
Pulmonary/Respiratory ...Orally, rhinitis, increased cough, and sinusitis have been reported with the use of psyllium (1376).
Other
...Some patients can have an allergic response to blond psyllium.
Allergy symptoms include allergic rhinitis, sneezing, conjunctivitis, urticarial rash, itching, flushing, and dyspnea. More serious symptoms include wheezing, facial and body swelling, chest congestion, chest and throat tightness, cough, diarrhea, hypotension, loss of consciousness, and anaphylactic shock. Occupational exposure or repeated ingestion of psyllium can cause sensitization, which can lead to serious allergic reactions (2328,2329,2330,8079,9246,92193). Severe allergic reactions may occur after eating a small quantity of cereal that contains blond psyllium. At least one cereal (Heartwise, Kellogg Co.) has increased the purity of the psyllium it contains, which has decreased the incidence of allergic reactions (9244). A warning of the potential for allergic reactions is on the label of all cereals that contain psyllium (9247). Patients hypersensitive to psyllium usually have marked eosinophilia and an elevated psyllium-specific IgE antibody serum level (2328,2329,92193).
There is concern that individuals allergic to pollen from English plantain weed (Plantain lanceolate) might also react to psyllium husk dust; however, it appears that there is little cross-allergenicity between these plants and is probably mild and of no clinical significance (8057,9244,92193).
Blond psyllium has a tendency to plug feeding tubes. This can be avoided if blond psyllium is mixed with water and pushed through the feeding tube in less than 5 minutes (8423).
General
...Orally, hawthorn seems to be well tolerated when used appropriately.
Topically, no adverse effects have been reported, although a thorough evaluation of safety outcomes has not been conducted.
Serious Adverse Effects (Rare):
Orally: Multiorgan hypersensitivity reactions resulting in acute renal failure have been reported rarely.
Cardiovascular ...Orally, tachycardia (with facial pains) of uncertain relationship to hawthorn was reported in a multicenter clinical trial (54640). Palpitations (19244) were reported in three patients in a large surveillance trial of 3,664 patients with cardiac failure (54692) and in 11 patients with congestive heart failure (CHF) in a literature review of 5,577 patients (19247). Circulation failure has been reported in two patients with CHF in a literature review of 5,577 patients (19247). Incidences of hospitalization, hospitalization due to CHF, worsening of CHF, angina, and atrial fibrillation have also been reported with the use of hawthorn extract WS 1442 (Crataegutt forte), although it is unclear if these events are related to hawthorn supplementation or existing CHF (19222). In clinical trials, chest pain (8281), short-term increases in blood pressure (19240), and other non-specific heart problems (17203) have also been reported following the use of various hawthorn preparations (e.g. WS 1442, Korodin).
Dermatologic ...Orally, erythematous rash has been reported in patients with CHF in a literature review of 5,577 patients (19247). Non-specific rashes and itching (19222,19243) as well as toxiderma from the fruits of hawthorn (54670) have also been reported.
Gastrointestinal ...Orally, rare abdominal discomfort of uncertain relationship to hawthorn has been reported in a large clinical trial, surveillance study, and a literature review (19247,54640,54692). Digestive intolerance (19241), diarrhea (19243), flatulence (8281), gastroenteritis (8281), increased bowel movements (19243), obstipation (8281), mild and rare nausea (10144,19247,19244), nutritional and metabolic problems (17203), and other non-specific gastrointestinal effects (19222), have also been reported. Furthermore, gastrointestinal hemorrhage has been reported in two patients with CHF in a literature review of 5,577 patients (19247).
Musculoskeletal ...In clinical trials, arthritis (8281), back pain (8281), weakness (19243), and other non-specific musculoskeletal effects (19222) have been reported following the use of various hawthorn preparations g. WS 1442, CKBM-A01).
Neurologic/CNS ...Orally, headache and dizziness/vertigo were reported in two patients in a large surveillance trial of 3,664 patients with cardiac failure (54692), in 15 patients with CHF as reported in a literature review of 5,577 patients (19247), and in a varying number of clinical trial participants (8281,19222,19244). Incidences of fainting (19222), fever (17203), and infrequent, mild and transient sleepiness have also been reported (19221,54692).
Psychiatric ...Orally, agitation was reported in a large surveillance trial of 3,664 patients with cardiac failure (54692).
Pulmonary/Respiratory ...Orally, bronchitis has been reported following the use of hawthorn extract WS 1442 (8281).
Renal ...A case of multiorgan hypersensitivity reaction and acute renal failure following the consumption of C. orientalis has been reported (54654).
Other ...Flu-like syndrome (8281) and other non-specific infections have been reported following the use of the hawthorn extract WS 1442 (17203,19222). Hawthorn has also been reported to cause nosebleeds (8281,10144).