Ephedra, or ma huang, the natural form of the stimulant ephedrine, the most infamous and dangerous drug found in dietary supplements sold for weight loss, is at last beginning to receive the negative notoriety it deserves. Ephedra causes heart attacks and strokes because of its ability to raise blood pressure and heart rate. This review was prepared to warn of a possible replacement for ephedra in anticipation that some dietary supplement producers will withdraw their ephedra products from...
Ephedra, or ma huang, the natural form of the stimulant ephedrine, the most infamous and dangerous drug found in dietary supplements sold for weight loss, is at last beginning to receive the negative notoriety it deserves. Ephedra causes heart attacks and strokes because of its ability to raise blood pressure and heart rate. This review was prepared to warn of a possible replacement for ephedra in anticipation that some dietary supplement producers will withdraw their ephedra products from the market.
Nevertheless, some dietary supplement producers will continue to market untested, unproven weight loss concoctions with ingredients that may be safer, or more dangerous, than ephedra until Congress repeals the Dietary Supplement Health and Education Act (DSHEA) of 1994. Under this law our scientifically-challenged Congress miraculously changed an endless number of naturally occurring drugs into foods and created the unregulated dietary supplement market in which the watchword is: LET THE BUYER BEWARE.
The basis for this review is testimony given by the U.S. General Accounting Office before a Senate hearing on dietary supplements for weight loss held in July 2002. Supplements that are known to be promoted for weight loss are listed in alphabetical order by their most common name. Information, if known, is given about their adverse effects, contraindications (when a supplement should not be used), and interactions with regulated drugs or other supplements.
Because safety and effectiveness testing are not required before dietary supplements are sold, this is the best evidence we have at this time about the adverse effects of various substances promoted for weight loss. Unfortunately, the information that is available is the result of someone needlessly harmed by one of these drugs masquerading as food.
Some ephedra pushers are getting out of the business because of lawsuits and insurance companies’ unwillingness to write product liability policies for ephedra producers. For example, Chattem Inc., the maker of ephedra-containing DEXATRIM products, announced the firm plans to stop shipping all ephedra-containing products by mid-September. The company already peddles two “ephedrine-free’’ DEXATRIM products formulated with bitter orange peel extract, Siberian ginseng and caffeine. More information about the adverse effects of bitter orange and caffeine can be found in the table below. The company would not disclose its reformulation plans for the ephedra products.
Chattem cites the recent scrutiny ephedra has received from the FDA and Congress, noting hearings held by Senator Richard Durbin’s (D-IL) in July criticizing weight loss supplements and the Health Research Group’s call for the Department of Health and Human Services to ban the sale of ephedra as some reasons for leaving the ephedra market. The text of this petition can be obtained on our Web site at www.citizen.org/publications/release.cfm?ID=7053, or by writing to us for a printed copy.
Senator Durbin held another round of ephedra weight loss supplement hearings on October 8, 2002 in which special attention was given to California based ephedra producer Metabolife. In late July 2002, the FDA asked the Department of Justice to pursue a criminal investigation of Metabolife about whether they made false statements to the FDA regarding the existence of adverse event reports associated with the use of their products.
Under pressure, Metabolife made public more than 13,000 adverse event reports from consumers in August. These were analyzed by the House Committee on Government Reform’s Minority Special Investigations Division, in conjunction with majority staff from the Senate Oversight of Government Management Subcommittee. Almost 2,000 of 13,000 reports involved “significant” adverse reactions according to the analysis.
Health Research Group director Dr. Sidney Wolfe was invited to participate in the Senate hearings. In part, Dr. Wolfe’s testimony was based on information from the U.S. military. Highlights from the testimony include:
From 1997 through part of 2001, there have been 30 deaths among active duty personnel in the armed forces in people who were using ephedra products. All were between the ages of their early 20’s and early 40’s and had been in good health prior to their deaths. There was no other explanation for their deaths. Since then, there have been three additional deaths associated with the use of ephedra products in the Army alone.
Partly as a result of these 33 deaths and other serious, non-fatal adverse events in the military associated with ephedrine, in July of this year memos were sent to all Army and Air Force military exchanges and commissaries worldwide stating that by the end of August 2002, all products containing ephedra should be removed from the shelves in these military posts for six months until the results of a Department of Health and Human Services review of ephedra is completed.
A complete copy of Dr. Wolfe’s testimony can be obtained on our Web site at www.citizen.org/publications/release.cfm?ID=7209, or by writing to us for a printed copy.
What You Can Do
As we have said repeatedly, you should not use dietary supplements other than vitamins and minerals. These products are unregulated, untested, and potentially dangerous.
|Drug Name||Adverse Effects||Contraindications||Interactions|
|Bitter Orange (Citrus aurantium)||sensitivity to light and increased blood pressure||should be avoided by persons with cardiovascular problems such as high blood pressure||unknown|
|Bladderwrack (Fucus vesiculosus)||high doses and prolonged use associated with a risk of iodine overdose and over active thyroid gland (hyperthyroidism)||should be avoided by persons with hyperthyroidism; long term use is not recommended||may have an additive effect with drugs used to lower blood sugar inpatients with type-2 diabetes|
|Brindle Berry (Garcinia cambogia; hydroxy citric acid)||high doses are associated with gastrointestinal (GI) distress||should be avoided by persons with ulcers; high doses and long term use are not recommended||unknown|
|Caffeine (guarana, cola nut)||GI distress, nausea, dehydration, headaches, insomnia, nervousness, anxiety, muscle tension, heart palpitations, increased blood pressure||should be avoided by persons with ulcers; high doses and log term use are not recommended||May strengthen the action of central nervous system stimulants|
|Chromium||mild GI distress, anemia, blood abnormalities, liver problems, kidney failure, memory loss, muscle breakdown (rhabdomyolysis,) tissue damage, genetic damage, genetic mutation, cancer||should be used with caution by persons with a history of low blood sugar (hypoglycemia); should be used only under medical supervision by individuals with a history of high blood sugar or type 2 diabetes; high doses of chromium picolinate are not recommended||may cause steroid induced diabetes when taken in combination with other steroid medications|
|Conjugated Linoleic Acid (CLA)||GI distress and nausea||unknown||should not be used with medications, mineral oil, dietary supplements, or food additives that prevent absorption of fats|
|Dehydroepiandrosterone (DHEA)||altered hormones, increased facial hair, acne, scalp hair loss, oily skin, mood swings, aggressiveness, irritability, virilazation in women and enlarged breasts (gynecomastia) in men, a deepening of the voice, and menstrual cycle irregularities; also associated with insomnia, headaches, nervousness, fatigue, low energy, decreased high density lipoprotein (HDL) cholesterol ("good cholesterol"), heart rhythm disturbances, liver abnormalities, liver inflammation, and increased risk of heart disease, diabetes, stroke, and some hormone related cancers||should be used only under medical supervision by individuals at risk for hormone related cancer such as prostate, ovarian, endometrial, and breast cancer; long term use may worsen precancerous cell changes in the prostate gland, high doses are not recommended.||may alter the effects of antidepressants, estrogen and estrogen-like medications, anticoagulants (blood thinners), central nervous system stimulants, and diabetes medications|
|Dieter's Teas (containing aloe, buckthorn, cascara, castor oil, rhubarb root, senna, or other herbal laxatives)||GI distress, stomach cramps, pain, constipation, nausea, vomiting,and diarrhea (sometimes chronic), fainting, dehydration, electrolyte abnormalities, potassium deficiency, kidney problems, swelling, accelerated bone deterioration, heart rhythm disturbances||should be avoided by persons with abdominal pain of unknown origin, diarrhea, dehydration, intestinal obstruction, and any inflammatory condition of the intestines (appendicitis, colitis, Crohn's disease, irritable bowel syndrome, or ulcerative colitis); aloe should be avoided by persons with hemorrhoids or kidney problems; rhubarb should be used with caution by persons with a history of kidney stones; use for more than two weeks is not recommended||may alter the effects of drugs used to treat heart rhythm disturbances(antiarrhythmics), digitalis or digoxin (LANOXIN), electrolytes such as potassium replacement, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen(MOTRIN), and decrease the absorption of other oral medications; potassium deficiencies associated with the use of stimulant laxatives can lead to disorders of heart function and muscle weakness, especially with use of digoxin, water pills (diuretics), and steroids; aloe may lower blood sugar levels and alter the effect of drugs used to treat diabetes; senna decreases the absorption of estrogens|
|Ephedra (ma huang)||loss of appetite, nausea, vomiting, disturbances of urination, sweating, dilation of eyes, insomnia, irritability, nervousness, dizziness, shortness of breath, elevated body temperature, tremor, muscle injury, nerve damage, severe headaches, memory loss, psychosis, increased blood pressure, heart palpitations, seizures, stroke, heart attack, and death; high doses associated with dependency||should be avoided by persons with glaucoma, thyroid disease, diabetes, high blood pressure, or heart disease; should also be avoided by those with difficulty in urination due to an enlarged prostate; should be used only under medical supervision by individuals with a kidney disorder, psychiatric disorder, or seizure disorder; should be discontinued at least 24 hours before surgery||may alter the effects of heart medications; should not be used with other medications including nonprescription allergy, asthma, cough-cold, weight control products, and antidepressants; use of ephedra with monoamine oxidase (MAO) inhibitor antidepressants strengthens the stimulant action of ephedra and may result in life threatening fever, elevated blood pressure, and coma|
|Fiber (chitosan, psyllium, methylcellulose, glucomannan, pectin)||GI distress including gas, bloating, intestinal cramps, abdominal distention, nausea, diarrhea, choking, and obstruction of the esophagus (tube between the mouth and stomach), throat, and intestines||should be avoided by persons with a history of intestinal obstruction, fecal impaction, or narrowing of the GI tract, and those who have difficulty controlling their diabetes; should be used with caution by individuals with shellfish allergies and insulin dependent diabetes (insulin and/or medication levels may need to be adjusted)||may alter the effects and decrease the absorption of drugs used to treat diabetes, cholesterol lowering drugs, anticoagulants (blood thinners), digoxin(LANOXIN), and other oral medications; high intake may decrease absorption of fatsoluble vitamins (A, D, E, and K) and carotenoids such as beta-carotene, lutein, and zeaxanthin|
|Green Tea (catechins)||GI distress, decreased appetite, insomnia, nervousness, hyperactivity, increased blood pressure, increased heart rate, and gastric irritation; high doses associated with headache, heart palpitations, and vertigo||should be used with caution by individuals with kidney disease, overactive thyroid (hyperthyroidism,) susceptibility to spasm, anxiety, and panic disorder; should be used only under medical supervision by persons with peptic ulcers, cardiovascular disease, and blood clotting abnormalities; should be avoided by persons with irregular heartbeat; should be discontinued at least 24 hours prior to surgery||may alter the effects of anticoagulant drugs and supplements (including vitamin E and ginkgo biloba), resulting in decreased platelet aggregation (blood clotting) and increased bleeding times|
|Guggul (myrrh)||GI distress, diarrhea, nausea, and skin rash||should be used only under medical supervision by persons with overactive thyroid gland (hyperthyroidism)||may alter the effects of thyroid drugs, cholesterol lowering drugs, anticoagulants (blood thinners), anti platelet drugs, propranolol (INDERAL), and diltiazem (CARDIZEM)|
|Gymnema||GI distress; extremely high doses associated with low blood sugar(hypoglycemia)||should be used only under medical supervision by individuals with active diabetes||may alter the effects of drugs used to treat diabetes and insulin, antidepressants, including St. John's wort and salicylates (white willow and aspirin), may enhance the effects of gymnema|
|5-Hydroxytryptophan (5-HTP)||nausea, vomiting, diarrhea, loss of appetite, difficult breathing, dilation of pupils, blurred vision, abnormally sensitive reflexes, loss of muscle coordination, and heart rhythm disturbances||should be avoided by persons with any significant cardiovascular disease; should be used only under medical supervision by individuals with cancerous tumors||should not be used with monoamine oxidase (MAO) inhibitor, other antidepressants (including herbal remedies such as St. John's wort), or prescription weight loss drugs|
|L-Carnitine||nausea, vomiting, diarrhea, abdominal cramps, and seizures||should be used only under medical supervision by persons with thyroid disease or seizure disorder||unknown|
|Pyruvate||GI distress including nausea, gas, bloating, and diarrhea||should be used only under medical supervision by persons with blood clotting problems; should be discontinued at least 14 days before surgery||unknown|
|St. John's Wort||GI distress, nausea, loss of appetite, constipation, dry mouth, sensitivity to light, allergic reactions, skin rash, hives, fatigue, insomnia, restlessness, dizziness, confusion, and fast or irregular breathing||should be avoided by persons who are attempting to become pregnant (may be mutagenic and toxic to sperm), and persons who have received organ transplants or are taking medications that decrease immune system activity; should be used only under medical supervision by persons with severe depression||may alter the effects of oral contraceptives, decrease the effectiveness of HIV drugs, immunosuppressants, digoxin (LANOXIN), anticoagulants (blood thinners), chemotherapy, and asthma drugs; may alter the effects of other prescription or over-the-counter drugs; should be used only under medical supervision when taking monoamine oxidase (MAO) inhibitor or other prescription antidepressants; should not be used with tyramine containing goods (certain wines,liver, and cheeses)|
|Vanadium||GI distress; high doses and long term use associated with muscle cramps, depression, and damage to the nervous system and other organs||should be avoided by persons with elevated blood sugar(hyperglycemia), low blood sugar (hypoglycemia), or diabetes||unknown|
|Yohimbe||queasiness, vomiting, insomnia, headache, sweating, flushing, nervousness, tension, tremors, difficulty breathing, hallucinations, anxiety, psychotic episodes, increased blood pressure, increased heart rate, heart palpitations, and chest pain; high doses are associated with decreased blood pressure, GI distress,and unpleasant central nervous system symptoms||should be avoided by persons with low blood pressure, diabetes, high blood pressure, kidney disease, liver disease, chronic inflammation of the sexual organs or prostate gland, cardiovascular disease, women who could become pregnant, and the elderly; high doses and long term use are not recommended||should not be used with antidepressant drugs or supplements, nasal decongestants, weight loss supplement with ephedrine, or tyramine containing foods (certain wines, lover, and cheeses)|