Co. Gives FDA Ephedra ComplaintsNov 19, 2002 | AP A leading seller of the dietary supplement ephedra gave the government records of 1,400 customer complaints Tuesday, including 14 that mention serious side effects.
Metabolife International already had turned over 14,700 customer health complaints as the Justice Department began a criminal investigation into whether the company had lied about ephedra's safety.
Ephedra is a popular herb commonly used for weight loss and body building, but it also has been linked to heart attacks, strokes and other serious side effects. Critics have called on the Food and Drug Administration to ban sales, and the agency has long sought manufacturers' records of consumer health problems as part of its safety investigation.
Metabolife's then-president told the FDA in 1998 that the company had never received any consumer complaints of serious side effects.
But in August, with disclosure of the Justice investigation, Metabolife announced that it was giving the FDA 14,700 records of telephone calls from ephedra customers about health-related issues.
Metabolife said the records mention three deaths, 20 heart attacks and 24 strokes. But the company stressed that the reports, unverified calls to a consumer hot line, are not medical records proving that ephedra actually caused any illnesses meaning the company hadn't lied.
Late Tuesday, Metabolife sent the FDA records of an additional 1,480 consumer telephone calls. The latest batch was received during a five-month time period in 2000, but had been missed previously because of a computer glitch, said Metabolife attorney Lanny Davis.
The latest records include two heart attacks, two strokes and 10 seizures, but there's no proof ephedra was the cause, Davis said.
"Metabolife continues to maintain that ... its product is safe and effective when taken as directed and after consultation with a physician," he said.
FDA spokesman Lawrence Bachorik confirmed the agency had received the new records.
"We would rather have had them early, but we will look at them carefully," he said. "Any adverse event reports are potentially important."
The FDA already has cracked down on ephedra products, such as "yellow jackets," that are illegally sold as an alternative to street drugs. But federal law allows dietary supplements that don't make illegal claims to be sold with little oversight unless the FDA proves them harmful.
Manufacturers, including Metabolife, argue that the pills are safe when used by healthy adults as directed on the products' labels. Metabolife has called for the FDA to mandate warning labels similar to ones it uses, and to require reporting of side effects.
But several scientists told Congress last month that ephedra causes heart attacks by constricting blood vessels, thus raising blood pressure and pulse rates. Canada has warned consumers to avoid it, and use has been banned by several U.S. athletic organizations.
"It is clear to me that there is a serious problem here," said Sen. Richard Durbin, D-Ill., who also is investigating ephedra. "If the FDA and the Bush administration don't protect American consumers, people will get sick and some will die."