Study: Ephedra Can Be Deadly
T R E N T O N, N.J., Nov. 6, 2000 -- Ephedra, an herbal stimulant used bymillions of Americans for bodybuilding and weight loss, can causecatastrophic complications, including heart attacks, stroke,seizures and death, researchers say.
They conclude the popular dietary supplement, also known as mahuang and often also containing caffeine, poses a risk that faroutweighs the small benefits, if any, the supplement offers.
Problems Uncommon, But Dangerous
“They’re uncommon events, but they’re serious,” said seniorresearcher Dr. Neal L. Benowitz, chief of clinical pharmacology atUniversity of California at San Francisco. “The substance isunreasonably hazardous as marketed.”
Benowitz and Dr. Christine A. Haller, a clinical fellow at theuniversity, both noted most of the cases they studied involvedyoung, healthy people struck with side effects while using ephedra.Some had been taking the daily supplement for just days or weeks,and two women who became pregnant while taking it lost theirbabies.
The research appears in the New England Journal of Medicine, which moved up release of the study to today because of theimportance of the finding.
Also today, the Food and Drug Administration warned Americansnot to use over-the-counter cold remedies or appetite suppressantsuntil their makers replace an ingredient that could cause strokes.FDA said it is taking steps to formally ban phenylpropanolamine, orPPA, which is a chemical cousin to the types of ephedra found inthe weight loss and bodybuilding products the Californiaresearchers studied.
Causing Complications
They reviewed records from 140 ephedra users who sufferedcomplications between June 1997 and March 1999, finding aboutone-third of the problems definitely or probably were caused by theephedra and another third possibly were caused by it. In one-fifthof the cases, there was insufficient information to drawconclusions, and the rest were deemed unrelated to ephedra use.
Dr. Steven Karch, an expert on drug-related deaths working forthe Ephedra Education Council, a group funded by supplement makers,said in some of the cases he believes pre-existing health problemssuch as heart disease, not ephedra, caused the complications. Healso noted that the FDA’s outside experts get research funding fromthe federal government.
But Dr. Stephen Schneider, an endocrinolgist and nutritionexpert at University of Medicine and Dentistry of New Jersey, saidthe study provides strong evidence ephedra caused the side effectsin many of the patients — but not enough evidence to ban it. Hesaid people should consult their doctor before taking it becausesome of the patients had medical conditions, were taking othermedicines or were drinking caffeine drinks that could heightenephedra’s effects.
People Unaware Taking Ephedra
“Many people have no idea that they’re taking it,” becauseit’s part of a supplement with limited or confusing information onthe label, Schneider said.
Schneider and Benowitz stressed ephedra should not be taken byanyone who is pregnant or has a history of heart disease, stroke,psychiatric disorders, asthma, thyroid or kidney disease, diabetesor prior seizures.
Benowitz and Haller said federal regulators should requirehealth warnings on products containing ephedra and should resurrecta proposal to impose dose limits. That idea was scrapped in 1997under pressure from the supplement makers’ industry and Congress’General Accounting Office, which said the 800 reports of sideeffects, including 44 deaths, FDA had collected by then didn’tprovide enough evidence to impose restrictions.
First Time In Medical Journal
So FDA asked Benowitz and Haller, another team of outsideexperts, and two in-house panels of scientists to evaluate thelatest batch of cases where ephedra users suffered heartpalpitations, very high blood pressure, heart attacks, strokes,seizures or other complications. The report by Benowitz and Halleris the first to appear in a medical journal.
Joseph Levitt, director of FDA’s food safety center, said thefour research groups had similar findings, although in some casesthey did not agree on whether ephedra was to blame.
John Hathcock of the Council for Responsible Nutrition, a tradegroup for supplement makers, criticized the criteria they all usedto classify which complications likely were due to ephedra. He alsosaid a study by other researchers about to published found no linkbetween such complications and ephedra use.
Ephedra products are often sold in health food stores, undernames ranging from Ripped Fuel, for bodybuilders hoping to increasemuscle and energy, to Metabolife and Diet-Phen for dieters.
Herbal ephedra is sold in about 200 unregulated dietarysupplements, and past research has shown the dosage in ephedrapills often varies widely from what’s on the label. Benowitzestimates about 12 million people used them last year.
Haller said she and Benowitz are just starting research todetermine what genetic or metabolism differences make some ephedrausers more likely to have problems.