What is Ephedrine, Ephedra and Ma Huang?
These terms are used to refer to the same substance derived from the plant Ephedra. (There are many common names for these evergreen plants, including squaw tea and Mormon tea.) Ephedra is a shrub-like plant that is found in desert regions in central Asia and other parts of the world. The dried greens of the plant are used medicinally. Ephedra is a stimulant containing the herbal form of ephedrine, an FDA-regulated drug found in over-the-counter asthma medications.
In the United States, ephedra and ephedrine are sold in health food stores under a variety of brand names. Ephedrine is widely used for weight loss, as an energy booster, and to enhance athletic performance. These products often contain other stimulants, such as caffeine, which may have synergistic effects and increase the potential for adverse effects. Ephedra is often touted as the "herbal fen-phen."
Ephedra's main active medical ingredients are the alkaloids ephedrine and pseudoephedrine. The ephedras also contain various tannins and related chemicals.The stem contains 1-3% total alkaloids, with ephedrine accounting for 30-90% of this total. The concentrations of these alkaloids depends upon the particular species of ephedra used.
Ephedrine alkaloids are amphetamine-like compounds used in OTC and prescription drugs with potentially lethal stimulant effects on the central nervous system and heart. The FDA has received more than 800 reports of adverse effects associated with use of products containing ephedrine alkaloid since 1994. These serious adverse effects, include hypertension (elevated blood pressure), palpitations (rapid heart rate), neurophathy (nerve damage), myopathy (muscle injury), psychosis, stroke, memory loss, heart rate irregularities, insomnia, nervousness, tremors, seizures, heart attacks, and death. The agency has proposed to prohibit the marketing of dietary supplements containing 8 milligrams or more of ephedrine alkaloids per serving.
Ephedra is one of the most dangerous of the dietary supplements.
Over 800 injuries have been reported by users and doctors to the FDA and various state medical bodies, including more than 50 deaths.
Most of these cases involve the heart attacks or high blood pressure leading to bleeding in the brain or stroke.
Recent studies sho wthat many people are seriously injured by the use of ephedrine. They are often unaware that ephedrine suppliers are can make wide ranging health claims about the product that have no scientific basis. Nor is there any mention of the potential for dangerous side effects. Because the industry was lobbyed to pass a law deregulating these products in l994, the FDA has been unable to regulate these products.
|FDA statement on street drugs containing botanical
FDA is warning consumers not to purchase or consume ephedrine-containing dietary supplements with labels that often portray the products as apparent alternatives to illegal street drugs such as "ecstasy." Possible adverse effects of ephedrine range from clinically significant effects such as heart attack, stroke, seizures, psychosis, and death, to clinically less significant effects that may indicate the potential for more serious effects (for example, dizziness, headache, gastrointestinal distress, irregular heartbeat, and heart palpitations). Ingredient panels on these products may list ma huang, Chinese ephedra, ma huang extract, ephedra, Ephedra sinica, ephedra extract, ephedra herb powder, or epitonin, all of which indicate a source of ephedrine.
The Food and Drug Administration proposed to reduce risks associated with dietary supplement products containing ephedrine alkaloids by limiting the amount of ephedrine alkaloids in products and requiring labeling and marketing measures that give adequate warning and information to consumers.
Ephedrine alkaloids are amphetamine-like compounds with potentially powerful stimulant effects on the nervous system and heart. Hundreds of consumer illnesses and injuries associated with the use of these products have been reported.
The proposal would not ban dietary supplements that contain ephedrine alkaloids.
"Consumers should be aware that just because a product is labeled 'natural' or from an herbal source it is not guaranteed to be safe," said Dr. Michael Friedman, Deputy Commissioner of Food and Drugs. "The effects of ephedrine alkaloids are potentially powerful ones. We urge people to talk to their doctors before using dietary supplements containing ephedrine alkaloids, and to always use them with caution."
Because ephedrine alkaloids are heart and nervous system stimulants, certain individuals including those with hypertension, heart conditions and neurologic disorders, should avoid their use. Pregnant women, too, should avoid the use of dietary supplements with ephedrine alkaloids.
The proposal would prohibit the marketing of dietary supplements containing 8 milligrams or more of ephedrine alkaloids per serving. Labeling that recommends or suggests conditions of use that would result in an intake of 8 mg or more in a 6-hour period or a total daily intake of 24 mg or more also would not be allowed.
In addition, the proposal would require label statements instructing consumers not to use the product for more than 7 days, and would not allow label claims for uses for which long-term intake would be necessary to achieve the purported effect. These safety measures are based on the fact that long-term intake of ephedrine alkaloids increases the likelihood of serious adverse events.
Another measure in the proposal would apply to products with claims that encourage short-term excessive intake to enhance the claimed effect, such as energy enhancement. Such products would be required to bear a labeling statement that "Taking more than the recommended serving may result in heart attack, stroke, seizure or death."
The proposal also would prohibit the use of other stimulant ingredients such as botanical sources of caffeine with ephedrine alkaloids because the combination increases the stimulant effects of ephedrine alkaloids and the chance of consumer injury.
Dietary supplement products containing ephedrine alkaloids are currently sold for a variety of purposes including weight loss, increased energy and body building.
Since 1994, the agency has received and investigated more than 800 reports of adverse events associated with the use of these products. Reported adverse events range from episodes of high blood pressure, irregularities in heart rate, insomnia, nervousness, tremors and headaches, to seizures, heart attacks, strokes and death. Most events occurred in young to middle aged, otherwise healthy adults using the products for weight control and increased energy.
Ephedrine alkaloids in dietary supplements are usually derived from one of several species of herbs of the genus Ephedra, sometimes called Ma huang, Chinese Ephedra and epitonin. Other botanical sources include Sida cordifolia.
The proposed measures were developed based on the FDA's review of its adverse event reports, the scientific literature, and public comments reviewed by the agency, including comments generated by an October 1995 advisory working group public meeting and an August 1996 public meeting of the FDA's Food Advisory Committee. These experts suggested a number of steps the agency might take to reduce injuries associated with use of dietary supplements containing ephedrine alkaloids.
Lack of FDA Regulation
People are unaware that suppliers of ephedra products are virtually free to make health claims about the substances that have no scientific basis. People are also unaware of the potentially deadly side effects of these products. Dietary supplements are routinely marketed without undergoing a safety review by FDA.
A law known as the Dietary Supplements Health and Education Act or "DSHEA," prevents the FDA from regulating these products. Prior to the DSHEA, dietary supplements were in regulatory limbo. The FDA claimed it had the power to regulate them and tried to make the manufacturers and suppliers prove their safety claims for their products.
The DSHEA reduced the FDA's and federal control over these products, compared with food and drugs, which are subjected to strict regulation and compliance mointering by the FDA. Under the DSHEA, dietary supplements like ephedrine are loosely defined as products intended to supplement the diet. These supplements contain herbs, minerals, amino acids, vitamins and combinations of these things. The supplement industry can sell any product that meets that definition in stores and its supplier can make claims about its alleged healthful qualities.
Herbal usage in the United States has increased dramatically since the passage of the DSHEA. In 1997, 60 million Americans spent $3.24 billion on herbs for reasons such as migraines, hypertension, depression, weight loss, and sexual stamina. An estimated 15 million adults are at risk for potential herb-drug interactions.
The deception occurs when the supplements industry selects brand names or uses wording on labels such as "fat burner" or "detoxifies" or "natural viagra" or the "#1 rated herbal" for impotence or "herbal fen-phen" to suggest the impossible. Under DSHEA, a herbal product label can state the way the product is intended to affect "the structure or function" of the body but cannot claim its use for a specific disease. Manufacturers use creative borderline language that complies technically with the law, but is generally confusing and deceptive. For example, one manufacturer claims its product "promotes regularity" instead of "treats constipation." How many consumers can discern the difference? Rather than stating Echinaeu "treats the flu" one manufacturer deftly says its product "promotes wellness during the flu season." These types of misleading claims are apparently permissible under the new laws and mislead consumers into believing these products are safe, when many clearly can have serious side effects.
Some companies have named their ephedrine tablets after illegal street drugs such as "Ecstasy" and "Black Beauties," as well as brand names such as Easy Trim, Advocare, Metabolite, Metab-Rx Ultar, Epitonin, Chinese Ephedra, Metabolife 356 and Ripped Fuel. Other manufacturers have taken a more subtle approach to sell their ephedrine products. These companies make representations that they are vitamin or nutrition companies that sell only "natural" diet supplements. Drug companies have taken advantage of the current status of ephedrine and have attempted to produce a "legal"
amphetamine by mixing ephedrine with other stimulants such as caffeine. Ephedrine use is highly popular among college students and people who work out. Most remain completely unaware of the potential dangers of these products.
People continue to believe that because herbs are "natural" they are therefore, harmless. However, many herbal remedies are dangerous. Many can interact with prescription medication. Some herbs become toxic if taken with certain drugs, and fatal herb-drug interactions can occur.
"Herbs are not regulated the same as other dietary supplements," says Donald D. Hensrud, M.D., a consultant in preventive medicine and endocrinology at Mayo Clinic in Rochester, Minn. "This means they can be misidentified, contaminated or contain multiple ingredients. There is no quality control for herbs."
"Patients electing to use herbal supplements for a serious disease in place of proven therapy are truly taking their lives in their own hands," says Thomas P. Moyer, Ph.D., director of the toxicology laboratory at Mayo Clinic, Rochester. "The growing trend of self-therapy is very concerning."
Excerpts from an article on the dangers of herbal supplements from
Journal of The New England Journal of Medicine
Now, with the increased interest in alternative medicine, we see a reversion to irrational approaches to medical practice, even while scientific medicine is making some of its most dramatic advances. Exploring the reasons for this paradox is outside the scope of this editorial, but it is probably in part a matter of disillusionment with the often hurried and impersonal care delivered by conventional physicians, as well as the harsh treatments that may be necessary for life-threatening diseases.
Fortunately, most untested herbal remedies are probably harmless. In addition, they seem to be used primarily by people who are healthy and believe the remedies will help them stay that way, or by people who have common, relatively minor problems, such as backache or fatigue. Most such people would probably seek out conventional doctors if they had indications of serious disease, such as crushing chest pain, a mass in the breast, or blood in the urine. Still, uncertainty about whether symptoms are serious could result in a harmful delay in getting treatment that has been proved effective. And some people may embrace alternative medicine exclusively, putting themselves in great danger. In this issue of the Journal, Coppes et al. describe two such instances.
Also in this issue, we see that there are risks of alternative medicine in addition to that of failing to receive effective treatment. Slifman and her colleagues report a case of digitalis toxicity in a young woman who had ingested a contaminated herbal concoction. Ko reports finding widespread inconsistencies and adulterations in his analysis of Asian patent medicines. LoVecchio et al. report on a patient who suffered central nervous system depression after ingesting a substance sold in health-food stores as a growth hormone stimulator, and Beigel and colleagues describe the puzzling clinical course of a patient in whom lead poisoning developed after he took an Indian herbal remedy for his diabetes. These are without doubt simply examples of what will be a rapidly growing problem.
What about the FDA? Shouldn't it be monitoring the safety and efficacy of these remedies? Not any longer, according to the U.S. Congress. In response to the lobbying efforts of the multibillion-dollar "dietary supplement" industry, Congress in 1994 exempted their products from FDA regulation. (Homeopathic remedies have been exempted since 1938. Since then, these products have flooded the market, subject only to the scruples of their manufacturers. They may contain the substances listed on the label in the amounts claimed, but they need not, and there is no one to prevent their sale if they don't. In analyses of ginseng products, for example, the amount of the active ingredient in each pill varied by as much as a factor of 10 among brands that were labeled as containing the same amount. Some brands contained none at all.
Herbal remedies may also be sold without any knowledge of their mechanism of action. In this issue of the Journal, DiPaola and his colleagues report that the herbal mixture called PC-SPES (PC for prostate cancer, and spes the Latin for "hope") has substantial estrogenic activity. Yet this substance is promoted as bolstering the immune system in patients with prostate cancer that is refractory to treatment with estrogen. Many men taking PC-SPES have thus received varying amounts of hormonal treatment without knowing it, some in addition to the estrogen treatments given to them by their conventional physicians.
The only legal requirement in the sale of such products is that they not be promoted as preventing or treating disease. To comply with that stipulation, their labeling has risen to an art form of doublespeak (witness the name PC-SPES). Not only are they sold under the euphemistic rubric "dietary supplements," but also the medical uses for which they are sold are merely insinuated. Nevertheless, it is clear what is meant. Shark cartilage (priced in a local drugstore at more than $3 for a day's dose) is promoted on its label "to maintain proper bone and joint function," saw palmetto to "promote prostate health," and horse-chestnut seed extract to "promote... leg vein health." Anyone can walk into a health-food store and unwittingly buy PC-SPES with unknown amounts of estrogenic activity, plantain laced with digitalis, or Indian herbs contaminated with heavy metals. Caveat emptor. The FDA can intervene only after the fact, when it is shown that a product is harmful.
Ephedra Containg Products
Ephedrine products are sold under dozens of brand names, to the right are some of the more popular brands.
The products are sold for a variety of reasons: ranging from weight loss to engery for work outs.
Many consumers may not be aware of the ephedra in the products or the levels or potency of the products.
If you have taken one of these products and have been injured you may want to Contact Ephedra Injury Lawyers
Metabolife 356® (Metabolife International)
Ripped Fuel (TwinLab Laboratories)
Extreme Ripped Force (American Bodybuilding)
Diet Fuel (Twin Laboratories)
GH Fuel (TwinLab Laboratories)
Herba Fuel (TwinLab Laboratories)
MetaboLift (TwinLab Labortories)
ThermiCare® (Met-Rx USA)
ETA Stack® (Nutra Sport)
Xenadrine RFA-1® (Cytodyne Technologies)
Ultimate Orange (Next Nutrition, Inc)
Vasopro (Mega Pro International)
Adipokinex (Syntrax Innovations, Inc)
Thermogenic Power (Nature's Herbs)
Chinese Ephedra (Frontiers, Inc.)
Chinese Ma Huang (Gaia Herbs, Inc)
Lipokinetix (Syntrax Innovations, Inc)
Clenbutrx (Vital Pharm, Inc)
BetaLean HP (EAS)
Diet Pep (Natural Balance, Inc)
Diurlean (ISS Research)
Dyma-Burn Xtreme (Dymatize Nutrition)