Arsenicum album 6 DH. Other Ingredients: Lactose, Sucrose.
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In 2004, Canada began regulating natural medicines as a category of products separate from foods or drugs. These products are officially recognized as "Natural Health Products." These products include vitamins, minerals, herbal preparations, homeopathic products, probiotics, fatty acids, amino acids, and other naturally derived supplements.
In order to be marketed in Canada, natural health products must be licensed. In order to be licensed in Canada, manufacturers must submit applications to Health Canada including information about uses, formulation, dosing, safety, and efficacy.
Products can be licensed based on several criteria. Some products are licensed based on historical or traditional uses. For example, if an herbal product has a history of traditional use, then that product may be acceptable for licensure. In this case, no reliable scientific evidence is required for approval.
For products with non-traditional uses, some level of scientific evidence may be required to support claimed uses. However, a high level of evidence is not necessarily required. Acceptable sources of evidence include at least one well-designed, randomized, controlled trial; well-designed, non-randomized trials; cohort and case control studies; or expert opinion reports.
Finished products licensed by Health Canada must be manufactured according to Good Manufacturing Practices (GMPs) as outlined by Health Canada.
This is a homeopathic preparation. Homeopathy is a system of medicine established in the 19th century by a German physician named Samuel Hahnemann. Its basic principles are that "like treats like" and "potentiation through dilution." For example, in homeopathy, diarrhea would be treated with an extreme dilution of a substance that normally causes diarrhea when taken in high doses.
Practitioners of homeopathy believe that more dilute preparations are more potent. Many homeopathic preparations are so diluted that they contain little or no active ingredient. Therefore, most homeopathic products are not expected to have any pharmacological effects, drug interactions, or other harmful effects. Any beneficial effects are controversial and cannot be explained by current scientific methods.
Dilutions of 1 to 10 are designated by an "X." So a 1X dilution = 1:10, 3X=1:1000; 6X=1:1,000,000. Dilutions of 1 to 100 are designated by a "C." So a 1C dilution = 1:100; 3C = 1:1,000,000. Dilutions of 24X or 12C or more contain zero molecules of the original active ingredient.
Homeopathic products are permitted for sale in the US due to legislation passed in 1938 sponsored by a homeopathic physician who was also a Senator. The law still requires that the FDA allow the sale of products listed in the Homeopathic Pharmacopeia of the United States. However, homeopathic preparations are not held to the same safety and effectiveness standards as conventional medicines. For more information, see the Homeopathy monograph.
Below is general information about the effectiveness of the known ingredients contained in the product Arsenicum Album (Globule). 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
Below is general information about the safety of the known ingredients contained in the product Arsenicum Album (Globule). 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 organic arsenic is consumed in normal food amounts. Organic forms of arsenic normally found in foods have not been linked to toxicity (7135,16309). ...when arsenic trioxide is used intravenously and appropriately under the guidance of a healthcare provider. Arsenic trioxide (Trisenox) is an FDA-approved prescription drug (15).
LIKELY UNSAFE ...when inorganic arsenic is used orally, especially when used long-term or in high doses. Taking large doses acutely, or in small doses for prolonged periods of time, can cause serious side effects. Chronic intake of 10 mcg/kg daily has been associated with symptomatic arsenicism. Acute doses of 5 mg, or sometimes less, can cause gastrointestinal symptoms. Higher doses can cause severe poisoning and death (7135,16310,16312,16313,16316,102892). Prolonged exposure to inorganic arsenic in drinking water and other sources has been linked to an increased risk of cardiovascular disease, diabetes, cancer, hypertension, and mortality (99824,99827,99829,99830,99832,99834,99835,109108,109110). Inorganic arsenic is classified as a human carcinogen (16312,16316). The maximum permissible level of arsenic in drinking water is 10 mcg/L (16316).
CHILDREN: LIKELY SAFE
when organic arsenic is consumed in food amounts.
Organic forms of arsenic found in a normal diet have not been linked to toxicity (7135,16309).
CHILDREN: LIKELY UNSAFE
when inorganic arsenic is used orally, especially when used long-term or in high doses.
Large doses acutely, or in small doses for prolonged periods of time, can cause serious side effects. Prolonged exposure to inorganic arsenic in drinking water has been linked to reduced scores on intelligence tests, developmental delays, impaired verbal comprehension, decreased memory and attention, and higher blood pressure in children (16319,99826,99828,99836,102898).
PREGNANCY AND LACTATION: LIKELY SAFE
when organic arsenic is consumed in food amounts.
Organic forms of arsenic found in a normal diet have not been linked to toxicity (7135,16309).
PREGNANCY AND LACTATION: LIKELY UNSAFE
when inorganic arsenic is taken orally, especially when used long-term or in high doses.
While exposure to inorganic arsenic in drinking water does not seem to increase the risk of neural tube defects (102897), it has been associated with an increased risk for spontaneous abortion, stillbirth, and neonatal mortality (99833). Exposure to inorganic arsenic in drinking water and other sources while pregnant has also been linked to changes in birth weight, length, and head circumference (102895), with one study showing that higher maternal blood arsenic levels are associated with 44% greater odds of delivering a small for gestational age infant and 103% greater odds of delivering a large for gestational age infant (102895,102896). Avoid arsenic supplements and water contaminated with arsenic during pregnancy or lactation.
Below is general information about the interactions of the known ingredients contained in the product Arsenicum Album (Globule). Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Arsenic trioxide can prolong the QT interval.
Details
Up to 40% of patients treated with prescription arsenic trioxide have a prolonged QT interval on their electrocardiogram (ECG) (15). Theoretically, non-prescription arsenic could have an additive effect when combined with drugs that prolong the QT interval.
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Below is general information about the adverse effects of the known ingredients contained in the product Arsenicum Album (Globule). 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, organic forms of arsenic found in the diet are well tolerated, with no clear links to adverse effects.
However, high doses or chronic intake of inorganic arsenic is associated with potentially serious adverse effects.
Serious Adverse Effects (Rare):
Orally: With the acute ingestion of inorganic arsenic, anemia, arrhythmias, bruising, gastrointestinal irritation or damage, hepatotoxicity, and peripheral neuropathy.
With chronic intake of inorganic arsenic, arsenicism can occur, including anorexia, cancer, skin hyperpigmentation and hyperkeratosis, and toxicity of the cardiovascular and neurological systems.
Cardiovascular
...Orally, doses of inorganic arsenic 1 mg/kg daily can cause hematopoietic depression including anemia, arrhythmias, and blood vessel damage leading to bruising (7135,16309,16312).
Acute ingestion of inorganic arsenic 10 mg/kg daily or more causes vasodilation and myocardial depression leading to myocardial injury, shock, and circulatory failure (17,7135,16313,16316,102892). Chronic intake of 10 mcg/kg daily of inorganic arsenic produces arsenicism, characterized in part by cardiomyopathy and arrhythmias (17,7135,16309,16310,16316). Prolonged exposure to inorganic arsenic in drinking water at levels greater than or equal to 20 mcg/L has been linked, in a dose-dependent manner, to a 9% to 43% greater risk of cardiovascular disease, 11% to 55% greater risk of coronary heart disease, and 16% to 90% greater risk of cardiovascular-related death (99827). Also, each interquartile increase in urinary inorganic arsenic levels is associated with an increased risk of both cardiovascular and all-cause mortality in a specific area of the US (109110). A metabolite of arsenic, monomethylarsonic acid, has also been positively linked to stroke risk (99831). Increased exposure to inorganic arsenic has also been linked to the development of left ventricular hypertrophy (99835). The cardiovascular adverse effects of inorganic arsenic appear to be more profound in males with hypertension (99829).
The association between arsenic exposure and hypertension has also been investigated. A meta-analysis of observational research has found that the odds of having hypertension and risk of hypertension were increased by 14% and 30%, respectively, in those with the highest arsenic exposure when compared with the lowest. Exposure was determined based on intake of rice and rice products, as well as exposure in water, or levels in urine, hair, or toenails (109108). Additionally, increased exposure to inorganic arsenic in drinking water has been linked to higher blood pressure in children (102898).
Dermatologic ...Orally, chronic intake of 10 mcg/kg daily of inorganic arsenic produces arsenicism, characterized in part by skin hyperpigmentation, hyperkeratosis, alopecia, and occlusive peripheral vascular disease leading to gangrene (17,7135,16309,16310,16316,102894). In one case, chronic intake of inorganic arsenic 30 ng daily has reportedly caused eczema of the hands, arms, and legs (102893).
Endocrine ...Orally, prolonged exposure to inorganic arsenic in drinking water has been associated with a 23% to 75% increase in the risk for diabetes (99830,99834). For every 100 mcg/L increase in inorganic arsenic levels in drinking water, the associated risk for diabetes increases by 13% (99834). A small meta-analysis has found that overall exposure to arsenic, including organic and inorganic arsenic, is associated with an increased risk of developing gestational diabetes (106539).
Gastrointestinal ...Orally, acute ingestion of inorganic arsenic 5 mg, or sometimes less, can cause vomiting, diarrhea, stomach cramps, and flatulence (16316,102893). These effects usually resolve in about 12 hours without treatment (16316). Doses of inorganic arsenic 1 mg/kg daily can cause gastrointestinal irritation (7135,16309,16312). Acute ingestion of inorganic arsenic 10 mg/kg daily or more causes severe gastrointestinal symptoms including bloody rice-water diarrhea (17,7135,16313,16316,102892). Chronic intake of 10 mcg/kg daily of inorganic arsenic produces arsenicism, characterized in part by anorexia and gastrointestinal disturbances (17,7135,16309,16310,16316).
Genitourinary ...Orally, chronic intake of inorganic arsenic 30 ng daily has reportedly caused irregular menstruation (102893). A long-term observational study in adults has found that exposure to inorganic arsenic from consumption of contaminated milk powder during infancy is associated with increased mortality from genitourinary diseases (106541).
Hematologic ...Orally, chronic intake of 10 mcg/kg daily of inorganic arsenic produces arsenicism, characterized in part by anemia, leukopenia, and occlusive peripheral vascular disease (17,7135,16309,16310,16316).
Hepatic
...Orally, doses of inorganic arsenic 1 mg/kg daily can cause hepatotoxicity (7135,16309,16312).
The homeopathic remedy, arsenicum album, has been associated with three cases of acute liver injury. In one case, a 70-year-old male with pre-existing non-alcoholic steatohepatitis (NASH) cirrhosis died following the acute liver injury associated with use of this compound for about 12 weeks. High levels of arsenic were found in his hair and nail samples. Symptoms in the two other individuals resolved upon discontinuation of homeopathic arsenic and use of corticosteroids (109114).
Musculoskeletal ...Orally, chronic intake of inorganic arsenic 30 ng daily has reportedly caused leg cramps in one patient (102893).
Neurologic/CNS
...Orally, doses of inorganic arsenic 1 mg/kg daily can cause peripheral neuropathy and encephalopathy (7135,16309,16312).
In one case, chronic intake of inorganic arsenic 30 ng daily has reportedly caused headache, dizziness, and difficulty concentrating (102893). Acute ingestion of inorganic arsenic 10 mg/kg daily or more can cause cerebral edema, leading to encephalopathy, convulsions, coma, and death (17,7135,16313,16316). Chronic intake of 10 mcg/kg daily of inorganic arsenic produces arsenicism, characterized in part by sensory disturbances, peripheral neuropathy, encephalopathy, confusion, and memory loss (17,7135,16309,16310,16316). A long-term observational study in adults has found that exposure to inorganic arsenic from consumption of contaminated milk powder during infancy is associated with increased mortality from nervous system diseases (106541).
In children, prolonged exposure to inorganic arsenic in drinking water has been linked to reduced scores on intelligence tests, developmental delays, impaired verbal comprehension, and decreased memory and attention (16319,99826,99828,99836).
Ocular/Otic ...Orally, chronic intake of inorganic arsenic 30 ng daily has reportedly caused conjunctivitis in one patient (102893). A long-term observational study in adults has found that exposure to inorganic arsenic from consumption of contaminated milk powder during infancy is associated with increased mortality from traffic accidents. This is suggested to be related to a higher prevalence of visual field narrowing due to macular degeneration, as well as motor or sensory dysfunction, in those exposed to arsenic during infancy (106541).
Oncologic ...Inorganic arsenic is classified as a human carcinogen (16312,16316). Orally, chronic intake of 10 mcg/kg daily of inorganic arsenic produces arsenicism, which can result in cancers of the skin, lungs, liver, kidneys, and bladder (17,7135,16309,16310,16316). Chronic ingestion of lower doses of inorganic arsenic, as a contaminant in well water, has also been linked to cancers of the skin, bladder, kidneys, and lungs (7135,99824,99832,106540). More specifically, levels of inorganic arsenic greater than 200 mcg/L in drinking water have been linked to lung cancer (99824). Levels of inorganic arsenic greater than 10 mcg/L in drinking water are also dose-dependently linked to an increased risk for bladder and kidney cancers (99832). A meta-analysis of observational research has found that arsenic exposure, especially from water and soil, is associated with prostate cancer risk (109109). A long-term observational study in adults has found that exposure to inorganic arsenic from consumption of contaminated milk powder during infancy is associated with increased mortality from liver cancer (106541).
Psychiatric ...Orally, chronic intake of inorganic arsenic 30 ng daily has reportedly caused insomnia and anxiety in one patient (102893).
Pulmonary/Respiratory ...A long-term observational study in adults has found that exposure to inorganic arsenic from consumption of contaminated milk powder during infancy is associated with increased mortality from respiratory diseases (106541).
Other
...Orally, high doses of inorganic arsenic can cause death.
In one case, a 24-year-old female receiving a combination of arsenic trioxide, realgar, and mung bean flour from an illegal medical provider died within days of taking the compounded preparation. Laboratory analysis revealed the amount of arsenic consumed to be around 1.1 grams on day 1 and 0.9 grams on day 4. Researchers concluded that arsenic as the source of poisoning was clear based on the amount of arsenic ingested and the patient's clinical presentation prior to death, which included vomiting, diarrhea, reduced urine output, liver and kidney abnormalities, and myocardial injury (102892).
A long-term observational study in adults has found that exposure to inorganic arsenic from consumption of contaminated milk powder during infancy is associated with increased all-cause mortality (106541).