FDA Cracks Down On Illegally Promoted Ephedra ProductOct 8, 2002 | AP A day after the government banned imports of an herbal drug containing ephedra, the parents of a teenager who died after taking the product testified Tuesday before a Senate hearing on how safe any ephedra-containing supplements are.
Sean Riggins was a 16-year-old athlete in exceptionally good condition, but on Sept. 2 he was so sick that he couldn't play in a big game with his Lincoln, Illinois, high school football team, testified his father, Kevin Riggins.
Instead, Sean sat on the bench, suffering from a headache and stomach pain, and later went home to sleep. A doctor, the next day, said he had bronchitis and sent him home. But within a few hours, Sean went into convulsions and stopped breathing. He died at a hospital of what doctors said was a heart attack.
"When my son passed away of a heart attack, I had no idea what to think," Kevin Riggins testified at a Senate subcommittee hearing. "He didn't smoke or do marijuana or take drugs."
But an autopsy showed that he did take Yellow Jackets, an herbal drug laced with the herb ephedra, along with a kola nut extract which contains caffeine. The combination can cause blood vessel constriction, a rapid heart beat, a sudden rise in blood pressure.
And that's what killed Sean Riggins, Logan County Illinois coroner Charles Fricke told the Senate Subcommittee.
"The heart was racing so fast it could not pump the blood," said Fricke. "It's our opinion that the (heart attack) is consistent with the effects of ephedrine. No other problems were found."
Sean's death was not the first caused by ephedra, a dietary supplement that is sold at service stations and convenience stores as an energy booster and weight control product, said Sen. Dick Durbin, an Illinois Democrat. He said Food and Drug Administration reports link ephedra to 81 deaths and 1,400 incidents of heart attack, high blood pressure and stroke.
And, yet, said Durbin, the FDA still allows the herbal supplement to be sold.
"We have seen a reluctance on the part of this administration to act to protect American consumers from this product and I just can't understand it," he said.
The FDA on Monday did stop imports of Yellow Jackets, e-mailing the Dutch operator of an Internet site selling the pills that it is illegal to market dietary supplements as alternatives to cocaine and other street drugs.
Ephedra is an herb that is legal to sell as a dietary supplement popular for weight loss and body building. But Durbin and some critics have asked the FDA to ban all ephedra products. One manufacturer, Metabolife International Inc. of San Diego, is now under investigation by the Justice Department about claims by a company official that it had received no reports of adverse health linked to its product.
Lanny Davis, a Washington attorney representing Metabolife, however, testified that many reports of dangerous side effects from ephedra are based on "unverified telephone calls."
He said there have been 30 scientific studies showing that Metabolife's ephedra product "is safe and effective" when used by adults as directed.
The Yellow Jackets issue is separate, focusing not on ephedra safety but on illegal marketing.
"There does not appear to be any legitimate use for this product," the FDA said in a warning letter e-mailed to the Dutch operator of a Yellow Jackets Web site.
"Consumers should not purchase or use these or similar products available through the Internet or elsewhere," FDA Acting Commissioner Lester Crawford said.
Riggins, in his testimony, said that students in Lincoln and in other small towns now can easily buy ephedra-laced supplements, using them to stay awake, to get a "buzz" and to lose weight.
Sean's mother, Debbie, said that "kids are the target" of manufacturers of Yellow Jackets and other ephedra supplements.
"They do it to get hyper so they can stay awake," said Debbie Riggins. "They will take several at a time to keep them wired all day."
Ephedra products have been banned in Canada. The U.S. armed services have ordered ephedra products removed from military base stores where they were once sold. The National Collegiate Athletic Association banned use of the supplement by student athletes and now conducts test each year to enforce that ban.
Dr. Ronald M. Davis of the American Medical Association said that based on reports of adverse medical effects, his organization believes "the weight of available clinical evidence supports the remove of dietary supplement products contain ephedrine alkaloids from the market."