Ephedra Under Fire
Calling it dangerous, even lethal, group wants supplement banned
MONDAY, Sept. 10, 2001 (HealthDayNews) -- A leading watchdog group is calling on the government to ban the sale and production of ephedra, the popular dietary supplement used as a weight-loss aid and energy booster for athletes.
Ephedra increases the risk for a heart attack, stroke or seizure because it raises your blood pressure, claims the group Public Citizen.
Calling ephedra "the most lethal" of all dietary supplements, the group has written the Food and Drug Administration asking for the ban.
Public Citizen is not the only group concerned about ephedra, however. Last week, the National Football League, in time for the first games of the 2001 season, banned the use of the supplement -- becoming the first professional sports league to do so. And Texas, in response to increasing consumer concerns, became the first state to mandate that manufacturers list a toll-free number on products containing ephedra so that users can report any health problems.
But the drug should be regulated, not banned, counters the Ephedra Education Council, an industry group. Plenty of studies have shown the supplement to be effective as a weight-loss aid when used properly, the council says.
"We knew a long time ago that ephedra, because it is close in chemical structure to amphetamines, raises blood pressure and heart rate," says Larry Sasich, a pharmacist and research associate for the Public Citizen Health Research Group. "Before the passage of the Dietary Supplement Health and Education Act in 1994, ephedra was not a controlled substance, though some strengths could only be obtained by prescription. But [the act] removed any oversight of the drug because ephedra is taken from a plant and is not considered a drug."
But the supplement has been associated with more deaths, heart attacks, heart rhythm problems, accounts of high blood pressure and strokes than all other dietary supplements combined, Sasich says, citing reports to the FDA between 1993 and February 2000.
Of the 3,308 problems reported, 1,393 were connected to ephedra -- including 81 deaths, 32 heart attacks, 62 reports of heart rhythm problems, 91 reports of excessive high blood pressure, 69 strokes and 70 seizures, he says.
Wes Siegner, legal counsel for the Ephedra Education Council, says banning is not necessary.
"The issue of whether ephedra should be banned, regulated or otherwise dealt with has been the subject of proposed regulations and other forms of debate for five years now," Siegner says. "The FDA already has a petition from all the trade groups requesting regulation of ephedra, which would include a limit on the serving amount and daily intake of ephedra, require comprehensive warning labels as well as including a warning against the use of the supplement by minors under the age of 18."
Ephedra is safe, Siegner says. "The clinical data shows that is it useful for people who want to lose weight and that it can be used safely for that purpose," he says.
Ephedra -- also marketed as Ma huang, Chinese ephedra and epitonin -- is an herbal supplement with a centuries-long pedigree in China. In the United States, advocates tout ephedra as a diet-loss aid or an energy boost for athletes. The herb works by stimulating the central nervous system, much like adrenaline and caffeine.
The Ephedra Education Council estimates that 3 billion servings of ephedra products are consumed each year in the United States.
"Because the drug can raise the heart rate, it presents dangers to people with diagnosed or undiagnosed heart disease," Sasich contends. "That leads to heart rhythm disturbance and sudden death. From the rise in blood pressure, you get stroke. The supplement can cause sleep disturbances, personality disorders, nervousness, headaches, hallucinations, gastrointestinal problems and skin eruptions."
Last year, the FDA decided to ban phenylpropanolamine, or PPA, a compound related to ephedra, as an additive to weight-loss aids and cold remedies, Sasich says.
Siegner says the group's petition has several problems. "The biggest problem is that it relies exclusively on adverse events reported to the FDA and to other sources," he says. "The petition does not take into account other studies that have shown the supplement to be effective and safe."
"And Public Citizen is claiming there's an increase in adverse event reports from 1997 through 1999," Siegner continues. "The fact is, there has been a huge increase in sales. The data we have from a survey done for us by Arthur Anderson shows a tripling of sales of ephedra in that two-year period."
"So the point is, if you don't look at the consumption data, and only the adverse event data, the numbers look like they're going up when in fact they're not," he says.
But Public Citizen wants the supplement banned immediately, "and we want the FDA to put out a public health advisory about its dangers," Sasich says. "The Canadian government, based on the FDA data, warned their citizens by putting out a health advisory on the dangers of the drug along and in combination with other stimulants like caffeine," he says.
And what does the FDA think about all this?
"We'll carefully respond to the petition when we receive it," says Ruth Welch, a spokeswoman for the agency, headquartered in Rockville, Md.