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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Alzheimer disease. Although there is interest in using oral or intravenous chelation therapy products for Alzheimer disease, there is insufficient reliable information about the clinical effects of chelation therapy products for this condition.
• Angina. It is unclear if oral or intravenous chelation therapy products are beneficial for angina. Details: A small clinical trial (Program to Assess Alternative Treatment Strategies to Achieve Cardiac Health; PATCH) in patients with angina shows that 500-mL infusions of a multicomponent disodium ethylenediamine tetraacetic acid (EDTA) chelation solution (Endrate) does not improve exercise capacity or time to ischemia when compared with a placebo containing all components other than EDTA. The dose of EDTA was 40 mg/kg (maximum 3 grams per dose) and was provided over a period of 3 hours. Infusions took place twice weekly for 15 weeks and then monthly for 3 months. Each infusion also provided magnesium sulfate 750 mg, ascorbic acid 5 grams, and sodium bicarbonate 5 grams. All patients also took an oral multivitamin/multimineral product (108104). This study may have been underpowered to detect differences between groups. There is currently no information suggesting that the oral use of chelation therapy products is beneficial.
• Arsenic poisoning. Although there is interest in using topical chelation therapy products for arsenic poisoning, there is insufficient reliable information about the clinical effects of topical chelation therapy products for this condition.
• Atherosclerosis. Although there is interest in using oral chelation therapy products for atherosclerosis, there is insufficient reliable information about the clinical effects of chelation therapy products for this condition.
• Attention deficit-hyperactivity disorder (ADHD). Although there is interest in using oral chelation therapy products for ADHD, there is insufficient reliable information about the clinical effects of chelation therapy products for this purpose.
• Atopic disease. Although there is interest in using oral chelation therapy products for atopic disease, there is insufficient reliable information about the clinical effects of chelation therapy products for this purpose.
• Autism spectrum disorder. It is unclear if oral or topical chelation therapy products are beneficial for autism spectrum disorder. Details: Various chelation therapy products have been investigated in clinical research. One preliminary clinical trial in children aged 3-8 years with autism spectrum disorder shows that taking dimercaptosuccinic acid (DMSA) 10 mg/kg three times daily as chelation therapy does not improve sociability, communication with speech or language, or general stereotypical behaviors when compared with placebo. The DMSA was taken for 3 days and then repeated up to 6 times, with 11 days off between treatment periods. Prior to the initiation of this phase of the study, all children received at least one 3-day round of chelation therapy to ensure the excretion of high amounts of heavy metals; however, heavy metal excretion was not compared between groups . Also, half of the children received topical glutathione for 7 days (21057,108099,108109). Other preliminary clinical research in children aged 3-9 years with autism spectrum disorder shows that taking a single dose of DMSA 10 mg/kg increases urinary excretion of cadmium, mercury, and lead. Taking DMSA monthly for 6 months improves overall behavior when compared with baseline. However, only specific behaviors, such as relating to people, imitation, and communication, were improved; other behaviors, including emotional, visual, auditory, or intellectual responses, were not improved (108110). The validity of these findings is limited by the lack of a comparator group. Small clinical studies have also evaluated other chelation therapy products in children with autism spectrum disorder. These include rectal thiamine tetrahydrofurfuryl disulfide (108111) and oral, intravenous, rectal, or topical 2,3-dimercaptopropane-1-sulfonate (DMPS) (108098). However, there is insufficient reliable information available regarding their effects.
• Cancer. Although there is interest in using oral chelation therapy products for cancer, there is insufficient reliable information about the clinical effects of chelation therapy products for this use.
• Cardiovascular disease (CVD). It is unclear if oral or intravenous chelation therapy products are beneficial for CVD. Details: One large clinical study (the Trial to Assess Chelation Therapy; TACT) in adults with stable coronary disease following a recent myocardial infarction (MI) shows that receiving 500-mL infusions of a multicomponent disodium ethylenediamine tetraacetic acid (EDTA) chelation solution, with or without oral high-dose vitamins, reduces the composite risk of total mortality, recurrent MI, stroke, coronary revascularization, or hospitalization by about 18% over 5 years. However, there was no effect of EDTA on the risk of these individual endpoints. A sub-group analysis shows that the risk of this composite outcome is reduced by up to 41% in patients who also have diabetes, with no reduction in patients without diabetes (94983,94985). Also, receiving just the multicomponent disodium EDTA chelation solution without oral high-dose vitamins does not reduce the risk of this composite outcome when compared with placebo, even in the subgroup of patients with diabetes (94986). Each infusion provided EDTA 3 grams over a period of at least 3 hours in combination with ascorbic acid 7 grams, magnesium chloride 2 grams, potassium chloride 2 mEq, sodium bicarbonate 840 mg, pantothenic acid 250 mg, thiamine 100 mg, pyridoxine 100 mg, procaine hydrochloride 100 mg, and heparin 2500 units (94983,94985,94986). Significant limitations of the trial, including missing data and possible unblinding, limit the reliability of these findings (95697).
• Hypertension. Although there is interest in using oral chelation therapy products for hypertension, there is insufficient reliable information about the clinical effects of chelation therapy products for this condition.
• Influenza. Although there is interest in using oral chelation therapy products for influenza, there is insufficient reliable information about the clinical effects of chelation therapy products for this purpose.
• Lead toxicity. Although there is interest in using topical chelation therapy products for lead toxicity, there is insufficient reliable information about the clinical effects of topical chelation therapy products for this condition.
• Mercury toxicity. Although there is interest in topical chelation therapy products for mercury toxicity, there is insufficient reliable information about the clinical effects of topical chelation therapy products for this condition.
• Osteoporosis. Although there is interest in using oral chelation therapy products for osteoporosis, there is insufficient reliable information about the clinical effects of chelation therapy products for this condition.
• Parkinson disease. Although there is interest in using oral chelation therapy products for Parkinson disease, there is insufficient reliable information about the clinical effects of chelation therapy products for this condition.
• Peripheral arterial disease (PAD). It is unclear if oral or intravenous chelation therapy products are beneficial for PAD. Details: Individual preliminary clinical trials included in a systematic review have shown that intravenous disodium ethylenediamine tetraacetic acid (EDTA) has no beneficial effect on blood flow, walking distance, pain-free walking distance, blood lipid levels, or well-being in patients with PAD (5752,5753,5754,108103). Most studies have used EDTA 3 grams twice weekly, usually in combination with vitamins and minerals, over a period of up to 10 weeks (5753,108103). In addition, there is no information suggesting that the oral use of EDTA is beneficial.
• Uterine fibroids. Although there is interest in using oral chelation therapy products for uterine fibroids, there is insufficient reliable information about the clinical effects of chelation therapy products for this purpose. More evidence is needed to rate chelation therapy products for these uses.

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LIKELY EFFECTIVE

• Cystic fibrosis. Long-term nebulized hypertonic sodium chloride improves lung function and reduces pulmonary exacerbations in patients with cystic fibrosis. Details: Meta-analyses of clinical research in adults with cystic fibrosis show that, when taken along with a bronchodilator and other standard therapies, nebulized hypertonic sodium chloride in concentrations of 3% to 7%, up to 10 mL twice daily for 4 weeks, increases forced expiratory volume at one second (FEV1) when compared with isotonic saline (sodium chloride 0.9%) (26230,26230). This benefit was not seen at 48 weeks. Other clinical research in adults with cystic fibrosis shows that inhaling sodium chloride 7%, 4 mL twice daily for 48 weeks, does not improve FEV1 when compared with isotonic saline. However, chronic treatment with hypertonic saline does reduce the number of pulmonary exacerbations and increase the number of patients without pulmonary exacerbations when compared with isotonic saline (29402). It is not clear if this benefit occurs in children with cystic fibrosis. The Pulmonary Clinical Practice Guidelines Committee of the Cystic Fibrosis Foundation recommends that individuals with cystic fibrosis aged 6 years or older use nebulized hypertonic saline long-term to improve lung function, reduce the number of exacerbations, and improve quality of life (29403).

POSSIBLY EFFECTIVE

• Amphotericin B nephrotoxicity. Oral sodium chloride seems to prevent nephrotoxicity associated with use of amphotericin B. Details: Clinical research shows that administering oral or intravenous sodium chloride 150 mEq daily during treatment with amphotericin B can attenuate the rise in serum creatinine levels and preserve renal function when compared to treatment with amphotericin B alone (26226).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Bipolar disorder. It is unclear if oral sodium is beneficial in preventing lithium level fluctuations in patients with bipolar disorder. Details: A moderate-sized open-label clinical study in adults with type I bipolar disorder receiving lithium carbonate shows that taking sodium chloride 1 gram daily for 12 weeks along with dietary salt restriction of 1 gram daily reduces the percentage of patients with lithium level fluctuations above 0.8 mEq/L, but does not significantly affect serum sodium, potassium, aldosterone, or creatinine levels when compared with controls who were not salt restricted, but were advised not to consume additional salt at the table (112909). However, the interpretation of these findings is limited by missing data in both groups.
• Canker sores. Although there is interest in using topical sodium chloride for canker sores, there is insufficient reliable information about the clinical effects of sodium chloride for this condition.
• Congestive heart failure. It is unclear if oral sodium is beneficial in patients with acute decompensated heart failure requiring decongestive therapy with diuretics. Details: A moderate-sized clinical study in adults hospitalized with acute decompensated heart failure requiring high-dose intravenous furosemide shows that taking sodium chloride 2 grams three times daily for up to 96 hours does not affect patient weight or serum creatinine levels when compared with placebo (112911). However, the clinical relevance of this study is unclear and it may have been inadequately powered to detect a difference between groups.
• Conjunctivitis. Although there is interest in using ophthalmic sodium chloride for conjunctivitis, there is insufficient reliable information about the clinical effects of sodium chloride for this condition.
• Hyponatremia. Although there is interest in using oral sodium chloride for hyponatremia, there is insufficient reliable information about the clinical effects of oral sodium chloride for this condition.
• Pharyngitis. Although there is interest in using topical sodium chloride for pharyngitis, there is insufficient reliable information about the clinical effects of sodium chloride for this condition.
• Prematurity. It is unclear if oral sodium is beneficial for premature infants. Details: Preliminary clinical research in infants born at less than 32 weeks' gestation shows that adding sodium 4 mEq/kg daily to enteral feedings, starting from the 7th day after birth and continuing through the 35th day, reduces the risk of developing hyponatremia and improves weight gain when compared with adding water (98180). A small, open-label clinical study in newborns less than 35 weeks gestation shows that high sodium intake, defined as an average of 0.25% sodium in maintenance fluids, for 48 hours on day 2 and 3 after birth results in less weight loss within the first 72 hours of life when compared with control, but does not improve mortality, length of hospital stay, or complications from prematurity (112908). However, interpretation of these findings is limited by varied concentrations of sodium as an intervention. More evidence is needed to rate sodium for these uses.

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POSSIBLY EFFECTIVE

• Constipation. Taking xanthan gum orally as a bulk-forming laxative seems to decrease constipation (4917,4918).
• Swallowing dysfunction. Using a specific xanthan gum product (Resource ThickenUp Clear, Nestle Health Science) as a thickener in liquid feeds improves swallowing and reduces the risk of aspiration in people with swallowing dysfunction similarly to a modified starch thickener (Resource ThickenUp, Nestle Health Science). Xanthan gum also does not appear to leave the pharyngeal residues seen with the modified starch product (100912,100913).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Diabetes. Taking xanthan gum 12 grams orally daily in muffins seems to lower blood glucose in people with diabetes (4916).
• Dry eye. Using eye drops containing xanthan gum and chondroitin sulfate (PRO-148 or Xiel ofteno, Sophia Laboratories) four times daily for 60 days improves tear film break-up times, ocular surface disease index, and symptoms of dry eye similarly to polyethylene glycol/propylene glycol eye drops (Systane, Alcon Laboratories Inc.) (89591,95794). It is not clear if this effect is due to xanthan gum, chondroitin sulfate, or the combination.
• Sjogren syndrome. Applying xanthan gum topically in the mouth seems to help as a saliva substitute in people with Sjogren syndrome (4915).

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POSSIBLY UNSAFE ...when unregulated chelation therapy products are used orally or parentally or when prescription chelation therapy products are used for unproven indications and/or in unapproved doses or routes of administration. The American College of Medical Toxicology and The American Academy of Clinical Toxicology recommend against the unapproved use of chelation therapy products (108106). Chelation therapy products can result in severe side effects including dehydration, hypocalcemia, kidney failure, neurodevelopmental toxicity, and death (107700,108095,108096,108105,108106,108107). Also, infusion of the disodium form of EDTA over less than 3 hours can cause severe, life-threatening adverse effects including hypocalcemia and death (5737).

CHILDREN: POSSIBLY UNSAFE
when unregulated chelation therapy products are used orally or parentally or when prescription chelation therapy products are used for unproven indications and/or in unapproved doses or routes of administration. The American College of Medical Toxicology and The American Academy of Clinical Toxicology recommend against the unapproved use of chelation therapy products (108106). Chelation therapy products can result in severe side effects including dehydration, hypocalcemia, kidney failure, neurodevelopmental toxicity, and death (107700,108095,108096,108105,108106,108107).

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when unregulated chelation therapy products are used orally or parentally or when prescription chelation therapy products are used for unproven indications and/or in unapproved doses or routes of administration. The American College of Medical Toxicology and The American Academy of Clinical Toxicology recommend against the unapproved use of chelation therapy products (108106). Chelation therapy products can have teratogenic effects and result in severe side effects including dehydration, hypocalcemia, kidney failure, neurodevelopmental toxicity, and death (107700,108095,108096,108105,108106,108107).

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LIKELY SAFE ...when used orally and appropriately. Sodium is safe in amounts that do not exceed the Chronic Disease Risk Reduction (CDRR) intake level of 2.3 grams daily (100310). Higher doses can be safely used therapeutically with appropriate medical monitoring (26226,26227).

POSSIBLY UNSAFE ...when used orally in high doses. Tell patients to avoid exceeding the CDRR intake level of 2.3 grams daily (100310). Higher intake can cause hypertension and increase the risk of cardiovascular disease (26229,98176,98177,98178,98181,98183,98184,100310,109395,109396,109398,109399). There is insufficient reliable information available about the safety of sodium when used topically.

CHILDREN: LIKELY SAFE
when used orally and appropriately (26229,100310). Sodium is safe in amounts that do not exceed the CDRR intake level of 1.2 grams daily for children 1 to 3 years, 1.5 grams daily for children 4 to 8 years, 1.8 grams daily for children 9 to 13 years, and 2.3 grams daily for adolescents (100310).

CHILDREN: POSSIBLY UNSAFE
when used orally in high doses. Tell patients to avoid prolonged use of doses exceeding the CDRR intake level of 1.2 grams daily for children 1 to 3 years, 1.5 grams daily for children 4 to 8 years, 1.8 grams daily for children 9 to 13 years, and 2.3 grams daily for adolescents (100310). Higher intake can cause hypertension (26229).

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately. Sodium is safe in amounts that do not exceed the CDRR intake level of 2.3 grams daily (100310).

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used orally in higher doses. Higher intake can cause hypertension (100310). Also, both the highest and the lowest pre-pregnancy sodium quintile intakes are associated with an increased risk of hypertensive disorders of pregnancy, including gestational hypertension and pre-eclampsia, and the delivery of small for gestational age (SGA) infants when compared to the middle intake quintile (106264).

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LIKELY SAFE ...when consumed in amounts found in foods, up to 10 mg/kg per day (4914). It has Generally Recognized as Safe (GRAS) status in the US (4912). ...when used orally for medicinal use in amounts up to 15 grams per day (4914,4916,4917,4918). ...when used topically and appropriately (4914,89591,95794).

PREGNANCY AND LACTATION:
Insufficient reliable information is available; avoid using in amounts greater than those found in foods.

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DIURETIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Concomitant use of ethylenediamine tetraacetic acid (EDTA) and potassium-depleting diuretics might increase the risk for hypokalemia.  Details EDTA can decrease serum potassium levels and increase excretion of potassium (15).

INSULIN Interaction Rating = Major Do not take this combination. Severity = High •  Occurrence = Probable •  Level of Evidence = B Ethylenediamine tetraacetic acid (EDTA) can decrease the activity of insulin and increase the risk for hypoglycemia.  Details Concomitant use of disodium EDTA with insulin can cause severe decreases in blood glucose concentrations (5737,5771). Additionally, EDTA chelates zinc in insulin products (15) and might interfere with the onset and duration of activity of various insulin preparations.

WARFARIN (Coumadin) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, disodium ethylenediamine tetraacetic acid (EDTA) can decrease the anticoagulant effects of warfarin.  Details Disodium EDTA has been reported to decrease international normalized ratio (INR) in a patient taking warfarin (4611).

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ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = A Theoretically, a high intake of dietary sodium might reduce the effectiveness of antihypertensive drugs.  Details High intake of dietary sodium can increase systolic and diastolic blood pressure (26222). Also, high intake of sodium may necessitate increased use of antihypertensive medications to achieve blood pressure control in some patients, such as those with chronic kidney disease (26223).

CORTICOSTEROIDS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Concomitant use of mineralocorticoids and some glucocorticoids with sodium supplements might increase the risk of hypernatremia.  Details Mineralocorticoids and some glucocorticoids (corticosteroids) cause sodium retention. This effect is dose-related and depends on mineralocorticoid potency. It is most common with hydrocortisone, cortisone, and fludrocortisone, followed by prednisone and prednisolone (4425).

LITHIUM Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = B Altering dietary intake of sodium might alter the levels and clinical effects of lithium.  Details High sodium intake can reduce plasma concentrations of lithium by increasing lithium excretion (26225). Reducing sodium intake can significantly increase plasma concentrations of lithium and cause lithium toxicity in patients being treated with lithium carbonate (26224,26225). Stabilizing sodium intake is shown to reduce the percentage of patients with lithium level fluctuations above 0.8 mEq/L (112909). Patients taking lithium should avoid significant alterations in their dietary intake of sodium.

SODIUM-CONTAINING DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Concomitant use of sodium-containing drugs with additional sodium from dietary or supplemental sources may increase the risk of hypernatremia and long-term sodium-related complications.  Details The Chronic Disease Risk Reduction (CDRR) intake level of 2.3 grams of sodium daily indicates the intake at which it is believed that chronic disease risk increases for the apparently healthy population (100310). Some medications contain high quantities of sodium. When used in conjunction with sodium supplements or high-sodium diets, the CDRR may be exceeded. Additionally, concomitant use may increase the risk for hypernatremia; this risk is highest in the elderly and people with other risk factors for electrolyte disturbances.

TOLVAPTAN (Samsca) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = C Theoretically, concomitant use of tolvaptan with sodium might increase the risk of hypernatremia.  Details Tolvaptan is a vasopressin receptor 2 antagonist that is used to increase sodium levels in patients with hyponatremia (29406). Patients taking tolvaptan should use caution with the use of sodium salts such as sodium chloride.

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General ...The use of chelation therapy products for unproven indications, or in unapproved doses or routes of administration, is generally considered to be unsafe.
Most Common Adverse Effects:
Orally: Gastrointestinal upset, nausea.
Intravenous: Abdominal cramps, anorexia, burning and pain at infusion site, diarrhea, headache, nausea, vomiting.
Serious Adverse Effects (Rare):
Orally: Allergic reactions, Stevens-Johnson syndrome.
Intravenous: Allergic reactions, arrhythmias, convulsions, death, heart failure, hypercalcemia, hypocalcemia, insulin shock, kidney failure, paresthesia, respiratory arrest, tetany, thrombophlebitis.

Cardiovascular ...Intravenously, chelation therapy products such as 2,3-dimercaptopropane-1-sulfonate (DMPS) or ethylenediamene tetraacetic acid (EDTA) have been associated with hypotension and irregular heartbeat (5737,5771,5772,108105,108106). Intravenously, EDTA can also cause thrombophlebitis (108099,108103). Disodium EDTA, when given as a rapid infusion or highly concentrated solution, can cause hypocalcemia, severe cardiac arrhythmias, respiratory arrest, and death (15,108102).
There are at least three case reports of intravenous chelation therapy-related hypocalcemia resulting in cardiac arrest. Two cases involved the use of disodium EDTA in children and one involved the unapproved use of an unknown type of EDTA over a 10- to 15-minute infusion in an adult (107700,108095,108096,108097,108105). At least in part because of these cases, disodium EDTA is no longer FDA-approved (108105). In a large clinical trial in patients with a previous myocardial infarction, the rate of hypocalcemia was 6.2% in patients given disodium EDTA, compared with 3.5% of those given placebo; however, disodium EDTA did not increase the risk of heart failure or death (94985).

Dermatologic ...There is a case report of Stevens-Johnson syndrome after two weeks of oral 2,3-dimercaptopropane-1-sulfonate (DMPS) chelation therapy in a child with chronic mercury exposure. Symptoms included a widespread eruption of red, itchy macules which gradually improved after discontinuation of DMPS therapy (108112). Rash has also been reported in patients given intravenous DMPS or oral dimercaptosuccinic acid (DMSA) (108099).
Intravenously, ethylenediamene tetraacetic acid (EDTA) can commonly cause exfoliative dermatitis (15,108103) and a burning sensation and pain at the site of infusion (5744,108103).

Endocrine ...Intravenously, calcium disodium ethylenediamene tetraacetic acid (EDTA) can cause zinc deficiency (5771,5772) and hypercalcemia (5771,5772). Disodium EDTA can occasionally reduce magnesium and potassium serum concentrations (5771,5772), and rarely cause insulin shock (5737).
Disodium EDTA, when given as a rapid infusion or highly concentrated solution, can cause hypocalcemia, leading to tetany, convulsions, cardiac arrhythmias, cardiac failure, respiratory arrest, and death. This has occasionally occurred when the disodium form of EDTA was used in error, instead of the calcium disodium form (15,94984,94985,107700,108095,108096,108097,108099,108105).

Gastrointestinal ...Intravenously, ethylenediamene tetraacetic acid (EDTA) can commonly cause abdominal cramps, anorexia, nausea, vomiting, and diarrhea (15). EDTA can also sometimes cause thirst (15).
When given orally or intravenously, 2,3-dimercaptopropane-1-sulfonate (DMPS) has caused nausea and dysgeusia.
Orally, dimercaptosuccinic acid (DMSA) has caused gastrointestinal upset and diminished appetite (108099).

Hematologic ...Intravenously, ethylenediamene tetraacetic acid (EDTA) can sometimes cause anemia (15), prolonged prothrombin time (5737) and transient bone marrow suppression (5737,5772).

Hepatic ...Intravenously, the calcium disodium form of ethylenediamene tetraacetic acid (EDTA) can cause mild elevations of serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and decreased alkaline phosphatase (ALP) levels (15,108102).
Orally, dimercaptosuccinic acid (DMSA) has been associated with mild elevations in liver transaminase levels (108105).

Immunologic ...Intravenously, disodium ethylenediamene tetraacetic acid (EDTA) can rarely cause histamine-like reactions (5737). There are rare reports of allergic reactions to EDTA given as a nasal provocation, topically, intradermally, and subcutaneously (94992). In one case report, a 57-year-old male presented with pruritus on the hands and feet, as well as urticaria and swelling of the face, following subcutaneous injection with a local anesthetic containing EDTA. Allergy to other ingredients in the anesthetic was ruled out, and intradermal and subcutaneous testing with calcium disodium EDTA confirmed the allergic response. The patient also reacted to radio-contrast medium containing EDTA (94992).
Topically, application of EDTA in cosmetics, shampoos, and other products has rarely been reported to cause contact dermatitis (94992).
Orally, dimercaptosuccinic acid (DMSA) has been associated with allergic reactions (108105).

Musculoskeletal ...Intravenously, disodium ethylenediamene tetraacetic acid (EDTA) can occasionally cause muscle cramps, back pains, muscle weakness, and myalgias (15). In a large clinical trial in patients with a previous myocardial infarction, the rate of hypocalcemia was 6.2% in patients given disodium EDTA, compared with 3.5% of those given placebo; however, only one patient had associated muscle cramping leading to a hospital visit (94985).

Neurologic/CNS ...Intravenously, ethylenediamene tetraacetic acid (EDTA) can commonly cause headache and faintness (15,108103). EDTA can also sometimes cause fever, chills, fatigue, and malaise (15,108099). Disodium EDTA can occasionally cause tremors, tingling, and paresthesias (15).
Orally, dimercaptosuccinic acid (DMSA) was associated with lethargy in one child in a clinical trial. Other possible adverse effects associated with DMSA included sleep problems (108099).

Pulmonary/Respiratory ...Intravenously, ethylenediamene tetraacetic acid (EDTA) can sometimes increase sneezing and nasal congestion (15). Inhalation of disodium EDTA contained in nebulizer solutions has been reported to cause dose-related bronchoconstriction (5765).

Renal ...Intravenously, ethylenediamene tetraacetic acid (EDTA) can sometimes cause urinary urgency and frequency (5772). However, the most serious adverse effect of EDTA is kidney toxicity (5772,108095,108099,108102) for doses greater than 3 grams daily (15). In a clinical trial in patients with angina, intravenous disodium EDTA has resulted in an elevation of serum creatinine (108104). EDTA can cause nocturia, hyperuricemia, polyuria, dysuria, oliguria, proteinuria, glycosuria, hematuria. and distal tubule and glomeruli changes (15). EDTA can also cause acute renal tubular necrosis, renal insufficiency, and renal failure (5772).

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General ...Orally, sodium is well tolerated when used in moderation at intakes up to the Chronic Disease Risk Reduction (CDRR) intake level. Topically, a thorough evaluation of safety outcomes has not been conducted.
Serious Adverse Effects (Rare):
Orally: Worsened cardiovascular disease, hypertension, kidney disease.

Cardiovascular ...Orally, intake of sodium above the CDRR intake level can exacerbate hypertension and hypertension-related cardiovascular disease (CVD) (26229,98176,100310,106263). A meta-analysis of observational research has found a linear association between increased sodium intake and increased hypertension risk (109398). Observational research has also found an association between increased sodium salt intake and increased risk of CVD, mortality, and cardiovascular mortality (98177,98178,98181,98183,98184,109395,109396,109399). However, the existing research is unable to confirm a causal relationship between sodium intake and increased cardiovascular morbidity and mortality; high-quality, prospective research is needed to clarify this relationship (100312). As there is no known benefit with increased salt intake that would outweigh the potential increased risk of CVD, advise patients to limit salt intake to no more than the CDRR intake level (100310).
A reduction in sodium intake can lower systolic blood pressure by a small amount in most individuals, and diastolic blood pressure in patients with hypertension (100310,100311,106261). However, post hoc analysis of a small crossover clinical study in White patients suggests that 24-hour blood pressure variability is not affected by high-salt intake compared with low-salt intake (112910). Additionally, the available research is insufficient to confirm that a further reduction in sodium intake below the CDRR intake level will lower the risk for chronic disease (100310,100311). A meta-analysis of clinical research shows that reducing sodium intake increases levels of total cholesterol and triglycerides, but not low-density lipoprotein (LDL) cholesterol, by a small amount (106261).
It is unclear whether there are safety concerns when sodium is consumed in amounts lower than the adequate intake (AI) levels. Some observational research has found that the lowest levels of sodium intake might be associated with increased risk of death and cardiovascular events (98181,98183). However, this finding has been criticized because some of the studies used inaccurate measures of sodium intake, such as the Kawasaki formula (98177,98178,101259). Some observational research has found that sodium intake based on a single 24-hour urinary measurement is inversely correlated with all-cause mortality (106260). The National Academies Consensus Study Report states that there is insufficient evidence from observational studies to conclude that there are harmful effects from low sodium intake (100310).

Endocrine ...Orally, a meta-analysis of observational research has found that higher sodium intake is associated with an average increase in body mass index (BMI) of 1. 24 kg/m2 and an approximate 5 cm increase in waist circumference (98182). It has been hypothesized that the increase in BMI is related to an increased thirst, resulting in an increased intake of sugary beverages and/or consumption of foods that are high in salt and also high in fat and energy (98182). One large observational study has found that the highest sodium intake is not associated with overweight or obesity when compared to the lowest intake in adolescents aged 12-19 years when intake of energy and sugar-sweetened beverages are considered (106265). However, in children aged 6-11 years, usual sodium intake is positively associated with increased weight and central obesity independently of the intake of energy and/or sugar-sweetened beverages (106265).

Gastrointestinal ...In one case report, severe gastritis and a deep antral ulcer occurred in a patient who consumed 16 grams of sodium chloride in one sitting (25759). Chronic use of high to moderately high amounts of sodium chloride has been associated with an increased risk of gastric cancer (29405).

Musculoskeletal ...Observational research has found that low sodium levels can increase the risk for osteoporosis. One study has found that low plasma sodium levels are associated with an increased risk for osteoporosis. Low levels, which are typically caused by certain disease states or chronic medications, are associated with a more than 2-fold increased odds for osteoporosis and bone fractures (101260).
Conversely, in healthy males on forced bed rest, a high intake of sodium chloride (7.7 mEq/kg daily) seems to exacerbate disuse-induced bone and muscle loss (25760,25761).

Oncologic ...Population research has found that high or moderately high intake of sodium chloride is associated with an increased risk of gastric cancer when compared with low sodium chloride intake (29405). Other population research in patients with gastric cancer has found that a high intake of sodium is associated with an approximate 65% increased risk of gastric cancer mortality when compared with a low intake. When zinc intake is taken into consideration, the increased risk of mortality only occurred in those with low zinc intake, but the risk was increased to approximately 2-fold in this sub-population (109400).

Pulmonary/Respiratory ...In patients with hypertension, population research has found that sodium excretion is modestly and positively associated with having moderate or severe obstructive sleep apnea. This association was not found in normotensive patients (106262).

Renal ...Increased sodium intake has been associated with impaired kidney function in healthy adults. This effect seems to be independent of blood pressure. Observational research has found that a high salt intake over approximately 5 years is associated with a 29% increased risk of developing impaired kidney function when compared with a lower salt intake. In this study, high salt intake was about 2-fold higher than low salt intake (101261).

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General ...Orally, xanthan gum can cause flatulence and abdominal distention (4916,4918). Topically, it has been reported to cause allergic reactions (100914).

Immunologic ...An itchy, burning dermatitis was reported in a 9-year old girl after application of a sunscreen product containing xanthan gum. Patch testing with the separate ingredients of the sunscreen identified xanthan gum as the reacting agent, and demonstrated a dose-dependent effect with 1% and 10% solutions (100914).

Pulmonary/Respiratory ...Occupational exposure in workers handling xanthan gum powder can cause flu-like symptoms and nose and throat irritation without acute or chronic loss of pulmonary function (4913).

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