Unknown . Ephedra
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On March 14, 2016, Health Canada recalled certain lots of this is product because it was found to be contaminated with the prescription drug yohimbine, which may result in adverse effects such as increased blood pressure (91151). This product also contains ephedra, also commonly known as ma huang. On April 14, 2004, the FDA issued its final ruling, stating that it will ban ephedra-containing products in the U.S. This is due to numerous reports that link ephedra use to severe adverse reactions including heart attack, stroke, hypertension, seizure, and others (10055). A report specific to Metabolife 356 indicates that a single dose can significantly prolong the QT interval and P wave duration. Both are risk factors for the development of arrhythmias. In addition, systolic blood pressure may also increase after one dose (11355). Advise patients not to use this or other products containing ephedra.
Below is general information about the effectiveness of the known ingredients contained in the product China White. 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 China White. 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 UNSAFE ...when used orally. Ephedra can cause severe life-threatening or disabling adverse effects in some people. Ephedra is banned in the US. Several case reports have linked ephedra to serious side effects including hypertension, myocardial infarction (MI), seizure, stroke, psychosis, and others (1276,2729,6486,6998,9167,10689). Prolonged use or use of high doses might increase the risk of serious adverse effects (2729). Some suggest that ephedra is only harmful when used inappropriately in excessive doses or for prolonged periods. However, there are several cases of significant adverse events in patients who used ephedra short-term in relatively low doses ranging from 20-60 mg of ephedra alkaloids (2729,6486). There is some evidence that people who take doses greater than 32 mg per day might have more than triple the risk of hemorrhagic stroke, including subarachnoid hemorrhage and intracerebral hemorrhage (9167). It is not possible to determine who is at the greatest risk. However, people with pre-existing conditions such as cardiovascular disease or those using ephedra products in combination with other stimulants such as caffeine, might be at increased risk.
CHILDREN: LIKELY UNSAFE
when used orally.
Ephedra has been linked to several cases of severe side effects (6486).
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally.
Ephedra has been linked to several cases of severe side effects (1276,2729,6486,6998,9167,10689).
Below is general information about the interactions of the known ingredients contained in the product China White. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Theoretically, ephedra may reduce the effects of anticonvulsants.
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Ephedra has been associated with reports of seizure (13304).
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Theoretically, taking ephedra with antidiabetes drugs might interfere with blood glucose control.
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One study in animals shows that some components of ephedra may lower blood glucose levels (48835). However, most human research suggests that ephedra and ephedrine, a component of ephedra, can raise blood glucose levels and might decrease the effectiveness of drug therapy (3719,12857,48810). Monitor blood glucose concentrations closely.
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Theoretically, large amounts of ephedra might increase the cardiac inotropic effects of beta-agonists.
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Theoretically, ephedra might decrease levels of drugs metabolized by CYP1A2.
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Some animal research suggests that ephedra induces CYP1A2 and increases the clearance of CYP1A2 substrates such as caffeine (91808).
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Theoretically, concomitant use might reduce the levels and clinical effects of dexamethasone.
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Theoretically, concomitant use might increase the risk of hypertension.
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The ephedrine contained in ephedra might cause excessive vasoconstriction and hypertension when used in combination with ergot derivatives (6009).
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Theoretically, concomitant use might have additive adverse hepatotoxic effects.
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Concomitant use might increase the risk of serious adverse effects.
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Use of ephedra with caffeine or other methylxanthines such as theophylline might increase the risk of stimulatory adverse effects (8641,24180). There is also some evidence that using ephedra with caffeine might increase the risk of serious life-threatening or debilitating adverse effects such as hypertension, myocardial infarction (MI), stroke, seizures, and death (1275,6486,10307,48751,54423,54429).
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Theoretically, concomitant use might increase the risk of serious adverse effects.
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Theoretically, ephedra might have an additive effect with drugs that prolong the QT interval.
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Even in healthy volunteers, EKG changes including prolonged QT interval and premature atrial contractions have been reported with ingestion of recommended doses of ephedra (11135,11708). Ephedra may have an additive effect with drugs that prolong the QT interval. This may increase the risk of ventricular arrhythmias (11355,48765).
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Theoretically, concomitant use might increase the risk for serious adverse effects.
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Below is general information about the adverse effects of the known ingredients contained in the product China White. 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, ephedra is frequently associated with adverse reactions and is banned in the US.
In some cases, adverse effects can be severe or life-threatening. Large studies looking at the safety of ephedra have not been performed. Since most of the adverse effect data are from case reports, it is impossible to determine the overall incidence of these adverse effects. It is also difficult to determine which patient groups might be most likely to experience an adverse event.
Most Common Adverse Effects:
Orally: Anorexia, anxiety, difficulty concentrating, difficulty urinating, dizziness, dry mouth, flushing, headache, heartburn, hyperthermia, hypertension, insomnia, irritability, nausea, personality changes, polydipsia, restlessness, tachycardia, tingling, and vomiting.
Serious Adverse Effects (Rare):
Orally: Cardiac arrest, cardiac arrhythmia, cardiomyopathy, heart failure, hepatotoxicity, myocardial infarction, myopathies, psychosis, seizure, stroke, and sudden death.
Cardiovascular
...The use of ephedra causes a 2.
2- to 3.6-fold increase in the risk of developing psychiatric, autonomic, or gastrointestinal (GI) symptoms and cardiac palpitations (9740,48878). Orally, ephedra use has been associated with cardiomyopathy (1270,48801), hypersensitivity myocarditis (1271,6487,48738,48739), chest tightness, myocardial infarction (6486), cardiac arrest and sudden death (1274,6486), hypertension, tachycardia, and cardiac arrhythmias (6009,8643,35749,35750,37689,48736,48737,48805,48847,48870,48872). Ephedrine abuse has led to heart failure (48813). Even in healthy volunteers, EKG changes including prolonged QT interval and premature atrial contractions can occur with ingestion of recommended doses of ephedra containing products (11135,11708). In a review of 926 cases reported to the FDA of possible adverse effects of ephedra, 37 patients had serious or fatal adverse reactions. Ephedra use was temporally related to 16 strokes, 10 myocardial infarctions, and 11 sudden deaths. These effects occurred in people aged 30-56 years. There is some evidence that people who take doses greater than 32 mg daily might have more than triple the risk of hemorrhagic stroke, including subarachnoid hemorrhage and intracerebral hemorrhage, when compared with those taking doses of less than 32 mg daily (9167,48771).
Ephedrine, the primary active ingredient in ephedra, has been associated with coronary artery spasm, myocardial injury with pulmonary edema, and cardiovascular collapse (48867,48872,48783). However, several clinical trials evaluating ephedrine-caffeine combinations for weight loss reported no differences in mean heart rate or blood pressure when compared to placebo (37617,48792,48865,48882). Other preliminary clinical research showed that ephedrine and caffeine use by prescription did not result in increased risk of adverse cardiovascular outcomes (48806).
Endocrine ...One study in animals shows that some components of ephedra may lower blood glucose levels (48835). However, most human research suggests that ephedra and ephedrine, a component of ephedra, can raise blood glucose and insulin levels (3719,12857,48810).
Gastrointestinal ...The use of ephedra causes a 2. 2- to 3.6-fold increase in the risk of developing psychiatric, autonomic, or gastrointestinal (GI) symptoms and cardiac palpitations (9740,48878). Orally and intravenously, ephedra and ephedrine most commonly cause dry mouth, anorexia, nausea, vomiting, heartburn, abdominal discomfort, and changes in stool consistency (1276,3719,6008,6486,8647,10004,10382,37831,48817,48837). One case of ischemic colitis and symptoms of abdominal pain and bloody diarrhea associated with the use of a weight loss supplement containing ephedra has been reported (48803).
Hepatic ...Cases of hepatotoxicity such as acute hepatitis and liver failure from ephedra-containing supplements have been reported. Some cases of hepatotoxicity resolved after discontinuation of ephedra, while others required liver transplantation. In obese patients using ephedra for weight loss, it is possible that ephedra exacerbated pre-existing liver disease. Onset of liver injury seems to occur an average of 3 months after ephedra ingestion, suggesting an idiosyncratic mechanism of liver injury (1273,48747,48800,94875,94876,94877,81600,98441). Previously, it was thought that the cause of ephedra hepatotoxicity was an immune reaction or a contamination. However, since the majority of evidence suggests that hepatotoxicity is idiosyncratic, these prior postulations have since been dismissed (1273,48747,81600,98441).
Musculoskeletal ...Orally, ephedra has been reported to cause myopathies, including myalgia, rhabdomyolysis, and eosinophilia-myalgia syndrome (1270,16054,48791).
Neurologic/CNS
...The use of ephedra causes a 2.
2- to 3.6-fold increase in the risk of developing psychiatric, autonomic, or gastrointestinal (GI) symptoms and cardiac palpitations (9740,48878). Ephedra most commonly causes dizziness, restlessness, anxiety, irritability, personality changes, difficulty concentrating, insomnia, and headache (1276,3719,6008,6486,8647,10004,10382).
Ephedra can cause seizures in otherwise healthy people, as well as in people with underlying seizure disorders (10307,48870). Of 33 seizures linked to dietary supplement use that were reported to the FDA over 7 years, 27 involved ephedra (13304). Other adverse events reported with ephedra use include sudden hearing loss, stroke, transient ischemic attack, cerebral hemorrhage, and loss of consciousness (1275,1381,2729,6486,8643,9167,10005,48746,48862). In one case-control study, doses of ephedra above 32 mg daily have been associated with an increased risk for hemorrhagic stroke (9167). A case of encephalopathy syndrome with multi-organ failure and transient cortical blindness after ingestion of a performance-enhancing ephedra supplement has been reported. Symptoms were resolved after blood pressure was corrected (48788).
Ocular/Otic ...A case of encephalopathy syndrome with transient cortical blindness after ingestion of an ephedra supplement has been reported. Symptoms were resolved after blood pressure was corrected (48788). A case of sudden hearing loss following the use of ephedra has also been reported (48761).
Psychiatric
...The use of ephedra causes a 2.
2- to 3.6-fold increase in the risk of developing psychiatric, autonomic, or gastrointestinal (GI) symptoms and cardiac palpitations (9740,48878). Ephedra most commonly causes anxiety, irritability, personality changes, difficulty concentrating, and insomnia (1276,3719,6008,6486,8647,10004,10382).
Cases of ephedrine-induced psychiatric complications (6998) include mania (48855), psychosis (1276,6998,10689,48751,48841,48843), and hallucinations (48857). In some cases psychosis can be prolonged for several months after discontinuation (1276,6998,10689). A case of a suicide attempt and mood disorder associated with the use of a diet pill containing ephedra has also been reported (48752).
Long-term use of ephedra or use in high doses has been associated with dependence and tolerance (1381).
Renal ...Orally, ephedra has been reported to cause nephrolithiasis (1272,48877), diuresis, urinary retention, and dysuria (16054,48791).
