Ephedra is a stimulant that affects the central nervous system to relax bronchial tubes. Its synthetic form is used in bronchodilators and over-the-counter medications like FDA - regulated Sudafed and Actifed. The drug is also commonly used as a source of ephedrine alkaloids for dietary supplements. In the United States, Ephedra is known as ma huang and is used in products for asthma, common cold, weight loss, allergies, congestion, cough, increased energy, and weight lifting formulas.
The FDA does not currently regulate ephedrine because it is protected under the Dietary Supplement Health & Education Act of 1994. Pursuant to the Act, the FDA cannot regulate dietary supplements such as ephedrine unless the supplement has been proven to be unsafe. Drug companies have abused the current status of ephedrine and have attempted to produce a "legal" amphetamine by mixing ephedrine with other stimulants such as caffeine.
On February 28, 2003, the Department of Health and Human Services announced a number of actions to address concerns about ephedra's safety. First, warning letters were sent to dozens of ephedra manufacturers challenging them to remove unproven claims or substantiate those claims, with a particular focus on athletic performance enhancement claims. Given the limited evidence on ephedra's benefits, FDA and the Federal Trade Commission are assessing whether further enforcement actions are warranted against other manufacturers. Second, a new, mandatory warning label for all marketed ephedra products was proposed. It would make it clear to users, via a black-box warning on the front of the product, as well as additional information in the product labeling, that serious adverse events and death have been reported after using ephedra, and that risks of adverse events are particularly high with strenuous exercise and/or use of stimulants including caffeine. Third, FDA announced that it was seeking comments from health professionals, the supplement industry, and the general public on any additional data on ephedra's safety, so that we can acquire the most complete picture possible of the product's potential risks.
A RAND study, recently commissioned by the National Institutes of Health, reviewed evidence on the risks and benefits of ephedra and ephedrine. The study found limited evidence of an effect of ephedra on short-term weight loss, and minimal evidence of an effect on performance enhancement in certain physical activities. It also concluded that ephedra is associated with higher risks of mild to moderate side effects such as heart palpitations, psychiatric and upper gastrointestinal effects, and symptoms of autonomic hyperactivity such as tremor and insomnia, especially when it is taken with other stimulants. The study reviewed over 16,000 adverse events reported after ephedra use and found about 20 "sentinel events" including heart attack, stroke, and death that occurred in the absence of other contributing factors. In conjunction with other recent studies of serious adverse events involving persons taking ephedra, the RAND study adds significantly to the evidence suggesting that ephedra as currently marketed may be associated with unreasonable safety risks.
A few of the incidents that have made Ephedra notorious:
- 1994 An Austin woman dies and 100 other Texans become ill after taking "Nature's Nutrition Formula One," leading to at least 21 lawsuits.
- 1996 Peter Schlendorf, 20, a student at the State University of New York in Albany, dies in a Florida hotel room during spring break, after taking "Ultimate Xphoria." The company settled the resulting lawsuit for $2.5 million.
- April, 2000 A pre-trial settlement is reached with the family of Rosanna Porraso, 15, who dropped dead during soccer practice.
- July, 2000 The CEO of Chemins Co. is sentenced to 21 months in prison and fined $4.7 million for spiking his ephedra product with ephedrine, the synthetic equivalent of the herbal product.
The Washington Post in 2000 reported that at least 75 lawsuits have been filed around the country, including two that are seeking class action certification. While most of the suits are still pending, some have reportedly settled for as much as $2.5 million.
In a Birmingham, Ala., case, McClain v. Metabolife International Inc., the jury ordered Metabolife to pay $4.1 million to four people who suffered strokes or heart attacks concurrently with Ephedra use.
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