2,4-dinitro-phenylhydrazine, alpha-methyldopa-hydrazine, beta-phenylisopropylhydrazine, carbidopa, diamide, diamine, dimethylhydrazine, hydrazine, hydrazine monosulphate, hydrazine sulphate, hydrazinium sulphate, hydrazonium sulphate, idrazina solfato (Italian), Sehydrin©.
Note: Hydrazine (N2H4), a precursor component of hydrazine sulfate and widely used industrial compound is generally not considered as within the purview of this monograph.
Hydrazine is a chemical compound. It is a colorless liquid with an ammonia-like odor. Hydrazine is converted to solid salts by treatment with mineral acids. A common salt is hydrazine sulfate, which is marketed as having the potential to reduce weight loss and cachexia (physical wasting with loss of weight and muscle mass caused by disease) associated with cancer, and to improve general appetite status However, based on studies in humans, hydrazine sulfate has not been proven effective for improving appetite, reducing weight loss, or improving survival in adults with small cell lung cancer (when used as adjuvant therapy) or metastatic colorectal cancer (when used alone).
Hydrazine sulfate causes liver damage in rodents. The U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services have determined that hydrazine sulfate may have cancer-causing effects.
Other applications of hydrazine include: corrosion inhibitor, herbicide and pesticide component, laboratory reagent, refining rare metals, soldering flux for light metals, silvering of mirrors, and rocket fuel.
These uses have been tested in humans or animals. Safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider.
The results of multiple clinical studies for the use of hydrazine sulfate in cancer-related cachexia are conflicting. The use of hydrazine sulfate cannot be fully recommended due to the lack well-designed studies and potential risks. More established therapies are recommended at this time.
The National Cancer Institute (NCI) sponsored studies of hydrazine sulfate that claimed efficacy in improving survival for some patients with advanced cancer. Trial results found that hydrazine sulfate did not prolong survival for cancer patients. The U.S. Food and Drug Administration (FDA) has received requests from individual physicians for approval to use hydrazine sulfate on a case-by-case "compassionate use" basis on the chance that patients with no other available effective therapy might benefit. The overall controversy in the use of hydrazine sulfate is ongoing, and relevance to clinical practice is unknown. The use of hydrazine sulfate needs to be evaluated further before any recommendations can be made. Side effects have been reported.
*Key to grades:
A: Strong scientific evidence for this use;
B: Good scientific evidence for this use;
C: Unclear scientific evidence for this use;
D: Fair scientific evidence against this use (it may not work);
F: Strong scientific evidence against this use (it likely does not work).
The below uses are based on tradition, scientific theories, or limited research. They often have not been thoroughly tested in humans, and safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider. There may be other proposed uses that are not listed below. Anorexia, antidepressant, antioxidant, appetite stimulant, biocide for molds and fungi (onychomycosis), blood disorders (analytical tests for blood), pain, Parkinson's disease, sickle-cell anemia, tuberculosis.
The below doses are based on scientific research, publications, traditional use, or expert opinion. Many herbs and supplements have not been thoroughly tested, and safety and effectiveness may not be proven. Brands may be made differently, with variable ingredients, even within the same brand. The below doses may not apply to all products. You should read product labels, and discuss doses with a qualified healthcare provider before starting therapy.
Adults (over 18 years old)
Hydrazine sulfate is not recommended for ingestion. Various doses have been used in clinical trials but are not recommended. 60 milligrams of hydrazine sulfate taken by mouth one to three times daily for 30 days in patients with cancer and/or cachexia. Injections have also been given by a healthcare provider.
Children (under 18 years old)
There is no proven safe or effective dose for hydrazine sulfate in children.
The U.S. Food and Drug Administration does not strictly regulate herbs and supplements. There is no guarantee of strength, purity or safety of products, and effects may vary. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy. Consult a healthcare provider immediately if you experience side effects.
Avoid in individuals with a known allergy or sensitivity to hydrazine sulfate.
Hydrazine sulfate can potentially cause allergic reactions. Rash has been reported.
Side Effects and Warnings
The FDA and the US Department of Health and Human Services have determined that hydrazine sulfate may cause cancer when swallowed.
Hydrazine sulfate is a skin and mucus membrane irritant. When swallowed side effects may include weakness and excitability, nausea, vomiting, pruritus (itching), headache, dizziness, drowsiness, insomnia, weakness, irregular breathing, confusion, low blood sugar, lethargy, violent behavior, restlessness, seizures, coma, and peripheral neuropathies (a disease or abnormality of the nervous system). Sweating has been reported in two patients in a small clinical trial.
Periarteritis nodosa and lupus has also been associated with hydrazine. Polyarteritis nodosa is a serious blood vessel disease in which small and medium-sized arteries become swollen and damaged when they are attacked by rogue immune cells. Lupus is a chronic inflammatory disease that can affect various parts of the body, especially the skin, joints, blood, and kidneys.
Hydrazine has been associated with low blood pressure, abnormal heart rhythms, septic shock, congestive heart failure, and facial swelling. A fatal case of liver and kidney failure has been reported.
Anorexia, heartburn, diarrhea, constipation, and hunger have been reported. Elevation of liver enzymes and "bad cholesterol" (LDH) have been reported.
Studies in humans have reported possible thrombophlebitis (vein inflammation), although it was unclear whether it was drug related. One report suggested hydrazine-induced platelet aggregation (blood clotting). Methemoglobinemia, a condition in which the iron in the hemoglobin molecule (the red blood pigment) is defective making it unable to carry oxygen effectively to the tissues, has been noted.
Hydrazine sulfate has been reported to cause paresthesia (upper and lower extremities), arthralgia or pain, depression, distorted sense of taste, palpebral tic, slurred speech, and hiccup; it may also affect fine motor functions. A paresthesia is a sensation of burning, prickling, tingling, or creeping on the skin that is often seen in multiple sclerosis (MS). Hydrazine sulfate either inhaled or used on the skin may cause irritation, burns, and permanent damage to the eye. Mydriasis (dilation of the pupil) and nystagmus (rapid involuntary oscillation/movement back and forth of the eyes) have been reported.
In a clinical trial, one patient had visual and auditory hallucinations.
A chest X-ray of a person who handled hydrazine for six months showed fluid in the lungs. An autopsy revealed severe trachea inflammation, bronchitis, and death due to pneumonia. Oral hydrazine sulfate may cause irregular breathing. Inhaled or topical use of hydrazine sulfate may cause bronchial mucus destruction, pulmonary edema, cancer, and death. Dyspnea (shortness of breath), rhinitis (inflammation of nasal mucosa), and cough have also been reported.
Use cautiously with drugs that are toxic to the liver or kidneys or in patients with liver or kidney disorders.
Hydrazine sulfate may lower blood sugar levels. Caution is advised in patients with diabetes or hypoglycemia, and in those taking drugs, herbs, or supplements that affect blood sugar. Blood glucose levels may need to be monitored by a qualified healthcare professional, including a pharmacist, and medication adjustments may be necessary.
Hydrazine sulfate may cause high blood pressure. Caution is advised in patients taking drugs that increase blood pressure or in patients with high blood pressure.
Use cautiously with sedatives, antihistamines, drugs used to treat seizures, bleomycin (a chemotherapy drug), and antipsychotics.
Avoid with antidepressants (monoamine oxidase inhibitors, selective serotonin reupate inhibitors, tricyclic antidepressants), meperidine, sympathomimetics, cyclobenzaprine, dextromethorphan, and levodopa due to the possibility of hypertensive crisis (dangerously high blood pressure) and/or serotonin syndrome.
Pregnancy and Breastfeeding
Hydrazine sulfate is not recommended in pregnant or breastfeeding women due to a lack of available scientific evidence.
Most herbs and supplements have not been thoroughly tested for interactions with other herbs, supplements, drugs, or foods. The interactions listed below are based on reports in scientific publications, laboratory experiments, or traditional use. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy.
Interactions with Drugs
One clinical study reported that a patient with lung cancer experienced flushing after alcohol ingestion while on hydrazine sulfate therapy.
Hydrazine is a monoamine oxidase inhibitor. Therefore, use of hydrazine with SSRIs, TCAs, tetracyclic, or other MAOI antidepressants or amphetamines should be avoided as it may result in hypertensive crisis (dangerously high blood pressure) and/or serotonin syndrome. A derivative of hydrazine has been used as an antidepressant in the MAOI family for the treatment of minor depressive states, but failed to show any beneficial results.
Dr. Joseph Gold, the pioneer in hydrazine use in cancer patients, has conducted several studies on the effects of hydrazine sulfate; he suggested that patients using hydrazine sulfate refrain from using benzodiazepines and barbiturates.
Hydrazine sulfate used with bleomycin, a chemotherapy drug, may lead to an additive effect of both agents. Hydrazine sulfate used with cyclophosphamide, a chemotherapy drug, may lead to enhanced antitumor effects of cyclophosphamide.
Hydrazine sulfate may lower blood sugar levels. Caution is advised when using medications that may also lower blood sugar. Patients taking drugs for diabetes by mouth or insulin should be monitored closely by a qualified healthcare professional, including a pharmacist. Medication adjustments may be necessary.
Hydrazine sulfate used along with isoniazid (an antituberculosis medication) may lead to enhanced effects of hydrazine.
Hydrazine may increase the length of time that levodopa (a drug used to treat Parkinson's disease) works.
Hydrazine sulfate used with methotrexate (a drug used to treat cancer) may lead to an additive effect of both agents.
Hydrazine sulfate used with mitomycin C may lead to enhanced antitumor effects of mitomycin C when these agents are administered six hours apart from each other. The study found that if hydrazine sulfate and mitomycin C are mixed in the same syringe, they inactivate each other.
Hydrazine sulfate may cause high blood pressure. Caution is advised in patients taking drugs that increase blood pressure.
Hydrazine sulfate may interact with alcohol, drugs used to treat seizures (anticonvulsants), antihistamines, antipsychotics, cyclobenzaprine, dextromethorphan, drugs that are toxic to the liver or kidneys, merperidine, sympathomimetics, and tramadol.
Interactions with Herbs and Dietary Supplements
Interactions may occur with herbs and supplements with the following properties: amphetamine-like, anesthetic-like, anti-depressant-like, anxiolytic-like, barbiturate-like, beta-blocker-like, central adrenergic-like, demerol-like, hypoglycemic-like, insulin-like, sympathomimetic-like, or theophylline-like. Use cautiously with herbs and supplements that are toxic to the liver or kidneys.
Hydrazine sulfate may alter blood sugar levels (induce hypoglycemia or hyperglycemia). Use with other herbs or supplements that alter blood sugar may result in either additive or negative effects when taken with hydrazine sulfate.
Based on animal studies, hydrazine is a monoamine oxidase inhibitor and therefore use of hydrazine with SSRIs, TCAs, tetracyclic, or other MAOI acting herbs or supplements should be avoided as it may result in hypertensive crisis and/or serotonin syndrome. An example is St. John's wort. A derivative of hydrazine has been used as an anti-depressant in the MAOI family for treatment of minor depressive states but failed to show any beneficial results.
Hydrazine sulfate is typically suggested as a cancer treatment, and thus hydrazine sulfate may interact with herbs or supplements also used for cancer. Caution is advised.
Hydrazine sulfate may cause high blood pressure. Caution is advised in patients taking herbs or supplements that raise blood pressure.
This information is based on a systematic review of scientific literature edited and peer-reviewed by contributors to the Natural Standard Research Collaboration (www.naturalstandard.com).
Natural Standard Bottom Line Monograph, Copyright © 2011 (www.naturalstandard.com). Commercial distribution prohibited. This monograph is intended for informational purposes only, and should not be interpreted as specific medical advice. You should consult with a qualified healthcare provider before making decisions about therapies and/or health conditions.
While some complementary and alternative techniques have been studied scientifically, high-quality data regarding safety, effectiveness, and mechanism of action are limited or controversial for most therapies. Whenever possible, it is recommended that practitioners be licensed by a recognized professional organization that adheres to clearly published standards. In addition, before starting a new technique or engaging a practitioner, it is recommended that patients speak with their primary healthcare provider(s). Potential benefits, risks (including financial costs), and alternatives should be carefully considered. The below monograph is designed to provide historical background and an overview of clinically-oriented research, and neither advocates for or against the use of a particular therapy.
The information in this monograph is intended for informational purposes only, and is meant to help users better understand health concerns. Information is based on review of scientific research data, historical practice patterns, and clinical experience. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions.
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Copyright © 2011 Natural Standard (www.naturalstandard.com)
Copyright © 2011 Natural Standard (www.naturalstandard.com)