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Ephedra

Ephedra is a plant that has been used for medicinal purposes in China for generations. It goes by many names, such as Ma Huang, herbal ecstasy, Mahuang, Mahuanggen and Ma Huang root. From the 1990's until its use was banned by the U.S. Food and Drug Administration (FDA) in 2004, ephedra was the main effective ingredient found in weight loss, bodybuilding, and energy supplements -- including Super Diet Max, Metabolife and Herbalife, for example. When combined with caffeine, ephedrine suppresses the appetite and stimulates a body's metabolism, but its effects are short term, meaning that it works only while it is being taken.

Because ephedra is marketed as a dietary supplement, the FDA had little control over it until very recently. Ordinarily, manufacturers are responsible for ensuring that a dietary supplement is safe before it is marketed, so the FDA could not regulate ephedra unless it was proven to be unsafe. In late 2003, the FDA made such a finding, announcing that consumers should stop all use of dietary supplements containing ephedra. The FDA ban on ephedra took effect nationwide on April 12, 2004.

Health Concerns Regarding Ephedra

It has been proven that ephedrine is an amphetamine-like compound, and amphetamines raise heart rate and blood pressure. Since ephedra can quicken a person's heart rate and cause their blood vessels to constrict, it may increase the risk of heart attack, seizure, stroke and sudden death.

Consequently, some companies that manufacture and distribute ephedra supplements try to conceal their ingredients, as well as risks. Alternatively, they try to mislead consumers by claiming on labels that a product is all-natural when, in fact, many ephedra products contain synthetic chemicals. In fact, even ephedrine can be produced synthetically. Thus, any product that claims to cause weight loss or increase energy potentially has ephedrine in it.

FDA Attention to Ephedra

In 1997, after more than 800 adverse events reports (AERs) associated with ephedra were submitted to the FDA, the FDA proposed rules for dietary supplements that contain ephedrine. It has been suggested that because there is no requirement that adverse events be reported to the FDA, the real number was probably much higher. The FDA's proposed rules called for a warning on the product label and a statement that the product not be used for more than seven days. They also required that the amount of ephedrine in one dose of a supplement be below 8 milligrams (mg), with a total intake of no more than 24 mg a day.

In late 2000, major trade associations representing the dietary supplement industry submitted a petition to the FDA for the withdrawal of the remaining portions of the 1997 proposal. The petition also requested the adoption, in its place, of an industry standard for the labeling and marketing of dietary supplement products containing ephedrine.

In September 2001, the Public Citizen Health Research Group petitioned the FDA to ban dietary supplements containing ephedra. According to the petition, the FDA received 1,393 reports of adverse events, including 81 deaths, linked to ephedra supplements from January 1993 until February 2001. At the time, an FDA spokeswoman said the agency would consider the petition.

On June 14, 2002, U.S. Department of Health and Human Services (HHS) Secretary Tommy Thompson announced that the government had hired the RAND Corporation to review the existing science on the safety of ephedrine, particularly when used in dietary supplements. The review was projected to be finished by early fall 2002 and, once complete, would then go to the National Institutes of Health (NIH) to determine if additional research was needed.

In July 2003, The widow of a Major League Baseball pitcher filed a $600 million wrongful-death lawsuit against the manufacturer of an ephedra-based dietary supplement. Kiley Bechler, widow of Baltimore Orioles Pitcher Steve Bechler, claims that the supplement caused her husband's death from heat stroke during a team practice in Florida.

In February 2004, the U.S. Food and Drug Administration handed down a final ruling banning the sale of all dietary supplements that contain ephedra. Based on the FDA's conclusion that use of ephedra in supplements presents an unreasonable risk to users, the nationwide ban becomes effective on April 12, 2004 (60 days after publication of the ruling).

Getting Help

Especially in light of the safety concerns raised over ephedra and the FDA's ban on all dietary supplements in which it is found, injured consumers may be able to recover damages from the manufacturers and distributors of products containing ephedra -- not just diet drugs. While all dietary products may have certain, anticipated side effects, a manufacturer has a duty to inform consumers adequately regarding the known risks associated with its product.  If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a "product liability" theory. If you have taken a product containing ephedra and experienced any unusual side effects, you should contact your physician at once. You should also contact an experienced attorney to discuss and protect your legal rights in connection with any harm caused by products containing ephedra.

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See also:

  • Why Drugs Get Pulled from the Market
  • Pharmaceutical Product Liability
  • Next Steps
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