Bottles of the popular herb ephedra should bear warning labels that the pills can cause heart attacks, strokes or even kill, the Food and Drug Administration said yesterday.
The FDA proposed the warning labels reviving an attempt the powerful dietary-supplement industry had blocked for years while saying a ban on at least some ephedra-containing products remains under discussion.
The action came less than two weeks after a medical examiner in Florida said the heatstroke death of Baltimore Orioles pitcher Steve Bechler was probably linked to his use of ephedra.
The FDA, which has reports of at least 100 deaths linked to ephedra supplements, had been under pressure from doctors for years to ban the controversial herb, but the death of Bechler renewed the scrutiny.
The FDA is seeking public comment on the warning labels and said they could be in place in a matter of months.
“Throughout America, there continue to be tragic incidents that link dietary supplements containing ephedra to serious health problems in consumers that use these products,” said Health and Human Services Secretary Tommy Thompson.
“I don’t know why anyone would take these products. Why take the risk?”
Thompson said an outright ban was still being considered.
“Dietary supplements containing ephedra may present a significant and unreasonable risk of illness and injury,” he said.
The FDA said it had warned 24 companies that target the amphetamine-like stimulant to athletes and bodybuilders that there is no scientific evidence that ephedra helps athletic performance – letters that signal the government is considering a bigger crackdown.
The FDA also released results of a long-awaited review by the Rand Corp., which concluded the herb probably has killed at least occasionally, without much benefit.
Ephedra has been linked to life-threatening side effects, even when used by healthy people at recommended doses, because it speeds heart rate and constricts blood vessels.