Definition :
Ephedra is a genus of plants found worldwide. One species, Ephedra sinica or Chinese ephedra, has a long history of use in complementary and alternative medicine (CAM). In the late twentieth century, ephedra gained popularity as a weight-loss supplement. The herb can cause life-threatening side effects, and since April 2004, sale of products containing ephedra have been banned in the United States. In Traditional Chinese Medicine (TCM) ephedra is called ma huang.
Purpose :
Ephedra (ma huang) has been used in TCM for about 5,000 years primarily to treat sneezing, runny nose, coughing and other symptoms of a cold, influenza, bronchitis, and allergy. In the 1990s ephedra was marketed in the United States as a dietary supplement that stimulated weight loss. It was also marketed to adolescents as a mood-altering ‘‘herbal Ecstacy’’ and to athletes to improve performance. In 2005 use of ephedra-containing supplements in the United States was banned.
Description :
Ephedra is an evergreen plant with tiny leaves that grows to a height of about 12 in (30 cm). Many species of ephedra are found worldwide, but E. sinica used in herbal medicine grows mainly in dry, rocky areas of Mongolia and northern China. The stems and roots of the plant are used medicinally. Many other species of ephedra, for example, E. nevadensis or Mormon tea that grows in the western United States, do not have the same active ingredients as E. sinica.
The active ingredients in ephedra are the alkaloids ephedrine and pseudoephedrine. These chemicals have effects similar to amphetamines. They stimulate the central nervous system and affect the heart and circulatory system. Ephedra causes blood vessels to narrow, increases heart rate, and raises blood pressure. These effects are enhanced when ephedra is taken with caffeine. Ephedra also expands the airways, making breathing easier. Researchers generally agree that ephedra is effective in treating cold and allergy symptoms.
Standardized amounts of manufactured ephedrine and pseudoephedrine, the active ingredients found in ephedra, are used in many cold and allergy products made by traditional pharmaceutical companies and approved for sale by the FDA. For years, these drugs were sold in the United States over the counter without restrictions. Beginning in the early 2000s, a movement developed to limit access to these drugs by placing them behind the counter at the pharmacy, limiting the amount an individual could buy, and requiring identification to purchase the drugs. This came about more because ephedrine and pseudoephedrine are used in the manufacture of illicit methamphetamines (e.g., crystal meth) than because of safety concerns about the drugs.
Ephedrine and pseudoephedrine are also effective appetite suppressants, especially when combined with caffeine. Many people who took diet pills containing ephedra or a combination of ephedra and caffeine did lose weight. However, they also experienced an increased risk of dangerous, sometimes fatal, side effects. Ephedra was brought to the attention of the FDA in the mid-1990s by a large increase in the number of reports from poison control centers and health care providers about serious adverse effects related to ephedra-containing weight-loss supplements. These side effects included dangerously high blood pressure, fast heart rate, stoke, and heart attack. By 2003, at least 155 deaths were linked to ephedra use, including that of Baltimore Oriole’s pitching prospect Steve Belcher. That same year, an analysis of side effects related to herbal therapy published in the Annals of Internal Medicine found that ephedra accounted for less than 1% of all herbal supplement sales, but was responsible for 64% of all reported negative events caused by herbs.
Ephedra and the Law :
The FDA regulates ephedra and other dietary supplements under the 1994 Dietary Supplement Health and Education Act (DSHEA). At the time the act was passed, legislators felt that because many dietary supplements come from natural sources such as plants and because they have been used for hundreds of years by practitioners of CAM, these products did not need to be regulated as rigorously as prescription and over-the-counter drugs used in conventional medicine. The legislators decided that dietary supplements should be regulated the same way food is regulated. As a result, manufacturers of ephedra supplements, just like the manufacturers of cheese or cereal, did not have to prove that ephedra was either safe or effective before it could be sold to the public. They also were not required to tell the public about possible side effects of the herb. (Conventional pharmaceuticals must include potential side effects in their packaging.)
With ephedra and all other dietary supplements, the burden of proof falls on the FDA to show that the supplement is either unsafe or ineffective before the supplement can be restricted or banned. Information about a supplement’s safety and effectiveness is normally gathered only after people using the product develop health problems or complain that the product does not work.
The FDA involvement with ephedra in weight-loss supplements began in 1996 after receiving more than 800 reports of adverse events in people taking products containing ephedra. In 1997 the FDA proposed regulating ephedra by requiring that the product carry a warning on the label stating that adults should take no more than 8 mg of ephedra at one time and no more than 24 mg in one day. The proposed regulation was fought by the diet supplement industry. During the course of public comment about the regulation, it became clear that there was little or no standardization of ephedra content among products or even within different batches of product from the same manufacturer. This lack of standardization made it difficult for consumers to know and control how much ephedra they were taking from day to day.
In 2002, the FDA commissioned and independent organization to study ephedra-related complications and deaths. As a result of this study, the FDA banned the uncontrolled sale of dietary supplements containing ephedra based on the what the FDA called an ‘‘unreasonable risk of illness or injury.’’ The ban took effect on April 14, 2005.
Several supplement makers have challenged the ban on ephedra-containing supplements in federal and state courts. They argue that the FDA did not test supplements containing low doses of ephedra for safety and effectiveness and that a total ban on ephedra supplements based only on high-dose products was illegal. The FDA took the position that it was unethical to do more human testing of ephedra given the findings that ephedra-containing supplements increase the risk of stroke, heart attack, irregular heart beat, and similar serious cardiovascular events. On October 18, 2006, after several legal challenges, the United States Court of Appeals Tenth Circuit upheld the FDA ban on all ephedra-containing supplements regardless of dose. Nutraceutical Corporation, the plaintiff in the case, vowed to file another a petition for review with the United States Supreme Court.
The ban on ephedra-containing supplements continues to be controversial. There is general agreement that ephedra does treat cold symptoms and does help people with short-term weight loss. However, these benefits do not, in the opinion of FDA scientists, outweigh the health risks associated with the ephedra-containing products. Ephedra continues to be legal in countries such as Germany, Japan, India, and China where it is widely used. Ephedra-containing supplements are easily available over the Internet, and it is estimated that several million Americans continue to use them.
Precautions :
The FDA warns that no one should take dietary supplements that contain ephedra because they can cause serious, sometimes fatal, side effects. Some individuals choose to ignore this warning. In that case, people with high blood pressure, heart problems, thyroid problems, enlarged prostate, and glaucoma, should avoid ephedra because there is a high risk the supplement will worsen their condition and could cause serious complications. Ephedra-containing supplements should not be given to children, pregnant women, or breastfeeding women.
Interactions :
Studies have shown that ephedra interacts with many drugs used in conventional medicine, especially those used to treat heart problems and monoamine oxidase inhibitors (MAOI) used to treat mental depression, anxiety, and phobias.
Complications :
At low doses, adverse side effects include headache, restlessness, anxiety, sleeplessness, nausea, difficulty urinating, and racing heart. At high doses, adverse reactions include sweating, enlarged pupils, fever, spasms, and death, usually through heart failure or stroke.
Parental concerns :
Ephedra is a dangerous herbal supplement and should not be given to children. Accidental use of ephedra by children can result in serious side effects. In the case of accidental poisoning in the United States, call the national poisoning hotline at 1-800- 222-1222, the local hospital emergency room, or emergency services.
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