Researchers Link Use of  Herbal Stimulant to Heart Attacks, Strokes and Seizures.

Ephedra, an herbal stimulant used by millions of Americans to lose weight and boost energy, can cause heart attacks, strokes, seizures and even death in otherwise healthy young people, researchers say. 

At least 54 deaths and about 1,000 reports of complications have been linked to ephedra since the mid-1990s. The researchers concluded that the dietary supplement, also known as ma huang, poses a risk that far outweighs any benefits it might have. 

"They're uncommon events, but they're serious," said Dr. Neal L. Benowitz, chief of clinical pharmacology at the University of California at San Francisco. "The substance is unreasonably hazardous as marketed." 

The research, commissioned by the Food and Drug Administration, appears in the New England Journal of Medicine, which moved up the release of the study from Dec. 21 to Monday because of the importance of the finding. 

Benowitz and his colleague, Dr. Christine A. Haller, noted that most of the cases they studied involved healthy young people. Some had been taking ephedra for just days or weeks, and two women who became pregnant while taking it lost their babies.

"Because of the severity of the adverse events that we reviewed, and, in particular, the occurrence of events that caused permanent disability and death, we conclude that dietary supplements that contain ephedra alkaloids pose a serious health risk to some users," Haller and Benowitz said in the study. 

Ephedra (pronounced eh-FED-ruh) products are often sold in health food stores under such names as Ripped Fuel - used by bodybuilders hoping to increase muscle and energy - as well as Metabolife and Diet- Phen for dieters. 

There are hundreds of unregulated ephedra products on the market. Benowitz estimated that 12 million people in the United States used ephedra products last year. 

Joseph Levitt, director of the FDA's food safety center, said the agency will decide by the end of the year whether to impose restrictions on ephedra or commission further research. In the study, the researchers reviewed records from 140 ephedra users who suffered complications from 1997 through 1999.

They found that about one-third of the problems definitely or probably were caused by the ephedra, and another third possibly were caused by it. In one-fifth of the cases, there was insufficient information to draw conclusions, and the rest were deemed unrelated to ephedra use. 

John Hathcock of the Council for Responsible Nutrition, a trade group for supplement makers, criticized the criteria used to classify which complications were probably caused by ephedra. He said an upcoming study by other researchers found no link between such complications and ephedra use. 

Dr. Steven Karch, an expert working for the Ephedra Education Council, a group funded by supplement makers, said that in some of the cases studied, he believes pre-existing health problems such as heart disease caused the complications.

Dr. Stephen Schneider, an endocrinologist and nutrition expert at the University of Medicine and Dentistry of New Jersey, said the study provides strong evidence that ephedra caused the side effects in many of the patients, but does not provide enough evidence to ban it. 

He said some of the patients had medical conditions, were taking other medicines or were drinking caffeine drinks that could heighten ephedra's effects. "Many people have no idea that they're taking it," because the label is often incomplete or misleading, Schneider said. 

Also, past research has shown that the dosage in ephedra pills often varies widely from what is on the label. Schneider and Benowitz stressed that ephedra should not be taken by anyone who is pregnant or has a history of heart disease, stroke, psychiatric disorders, asthma, thyroid or kidney disease, diabetes or seizures. 

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Benowitz and Haller said federal regulators should require health warnings on products containing ephedra, and should resurrect a proposal to impose dose limits. That idea was scrapped in 1997 under pressure from the industry. At the time, the FDA had 800 reports of side effects, including 44 deaths; the number has since risen. 

The FDA asked Benowitz and Haller, another team of outside experts, and two in-house panels of scientists to evaluate the latest batch of cases where ephedra users suffered heart palpitations, very high blood pressure, heart attacks, strokes, seizures or other complications. 

The study by Benowitz and Haller is the first to appear in a medical journal. The FDA's Levitt said the four research groups had similar findings, though in some cases, they did not agree about whether ephedra was to blame.