Ephedra

Ephedra is a genus of plants found worldwide. One species, Ephedra sinica, or Chinese ephedra (ma huang), has a long history of use in complementary and alternative medicine (CAM) and Traditional Chinese medicine (TCM). In the late twentieth century, ephedra gained popularity as a weight-loss supplement. The herb was reported to have caused life-threatening side effects and after studies confirmed the potential for side effects the US Food and Drug Administration (FDA) placed a ban on the sale of products containing ephedra; the ban was upheld for ten years (2004–2014) and was finally lifted by the FDA on April 1, 2014.

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, or allergy. In the 1990s, ephedra was marketed in the United States as a dietary supplement that stimulated weight loss. It was also marketed to athletes to improve performance and was sold underground to adolescents as the mood-altering herb Ecstasy.

Ephedra is an evergreen plant that grows to a height of about 12 in ches (30 cm). Many species of ephedra are found worldwide, but the E. sinica used in herbal medicine grows mainly in dry, rocky areas of Mongolia and northern China. The ephedra leaves are tiny, and only the stems and roots of the plant are used medicinally. Other species of ephedra such as E. nevadensis, and 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 are also produced in the human body to function as brain neurotransmitters. When taken as E. sinica, ephedrine and psydoephedrine have effects similar to amphetamines. They stimulate the central nervous system and affect the heart and circulatory system, causing blood vessels to narrow and blood pressure to rise and increasing the heart rate. These effects are enhanced when ephedra is taken with caffeine. Ephedra also expands the airways, increasing respiration and making breathing easier. Research has shown that ephedra is effective in treating cold and allergy symptoms.

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, dangerous, sometimes fatal, side effects increased among those taking the diet pills. A large increase in the number of reports from poison control centers and healthcare providers about serious adverse effects (i.e., dangerously high blood pressure, fast heart rate, stroke, and heart attack) related to ephedra-containing weight-loss supplements resulted in an FDA investigation. Ephedra was found to be responsible for 64% of all reported negative events caused by herbs.

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, that is, according to good manufacturing practices (21 CFR 111). 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 more than 800 reports of adverse events were received. 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 dietary supplements industry even though there was little or no standardization of ephedra content among products or within different batches of product from the same manufacturer. The lack of standardization made it difficult for consumers to know and control how much ephedra they were taking from day to day.

Over the years, several supplement makers challenged the ban on ephedra-containing supplements in federal and state courts, arguing 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 posited 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 heartbeat, 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.

The FDA ban on ephedra was lifted on April 1, 2014 after nutraceutical companies continued to challenge the status. The FDA cited that its motivation was the increasing epidemic of obesity in the U.S. population. A spokesperson for the dietary supplement regulatory division of the FDA stated that “Ephedra, when taken as directed—no more than 90 mg per day and not to be taken by those with preexisting heart conditions—is safe and effective for those who wish to lose weight.” Ephedra continues to be legal and widely used in Germany, Japan, India, and China. Ephedra-containing supplements are readily available in the United States and over the internet, and several million Americans are estimated to be using them.

The FDA still warns that dietary supplements that contain ephedra may cause serious, sometimes fatal, side effects if the recommended dosage is exceeded. Individuals with high blood pressure; history of stroke heart attack, or angina; irregular heartbeat; other heart problems; thyroid problems; enlarged prostate; urinary retention; seizures; or glaucoma are at increased risk for side effects and are advised not to take ephedra. Children, pregnant women, and breastfeeding women should not use ephedra-containing supplements.

No regulated manufacturing standards are in place for the preparation of products containing ephedra, which means that amounts of ephedra and dosage are uncontrolled and purity is not guaranteed.

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. Additional concerns relate to using it with other dietary supplements such as gingko biloba.

At low doses, adverse side effects may include headaches, restlessness, anxiety, sleeplessness, nausea, difficulty urinating, and racing heart. At high doses, adverse reactions may include sweating, enlarged pupils, fever, spasms, and death, usually through heart failure or stroke.

Ephedra is an herbal supplement with potentially dangerous side effects 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, parents or guardians are advised to call the national poisoning hotline at 1-800-222-1222, the local hospital emergency room, or emergency services.

See also Caffeine ; Dietary supplements ; Herbalife ; Obesity .