FDA plans warning labels for ephedra
Bottles will say risks include heart attacks, seizures, death
WASHINGTON (CNN) -- The Food and Drug Administration will require warning labels on products that contain ephedra, Department of Health and Human Services Secretary Tommy Thompson said Friday.
"Throughout America, there continue to be tragic incidents that link dietary supplements containing ephedra to serious health problems in consumers that use these products," Thompson said.
The move follows the death of Baltimore Orioles pitching prospect Steve Bechler on February 17. A Florida medical examiner said an ephedra supplement was linked to Bechler's death.
HHS and the FDA said the labels would include warnings that the supplements can cause heart attacks, seizures or death.
The label will affect how ephedra is sold and will "lay the legal groundwork needed for further regulatory restrictions," FDA Commissioner Mark McClellan said.
Ephedra is an herbal supplement that is found in many over-the-counter products designed to help people lose weight or increase their energy and has long been the subject of criticism.
In October 2002, members of the American Medical Association testified before Congress on the dangers of ephedra, and the group has urged the Food and Drug Administration to ban the diet aid.
The AMA said ephedra use is linked to heart attacks, strokes and seizures, among other conditions.
"I would not take this; I would not give it to my family. And I don't know why anyone would take these products," Thompson said.
HHS said a RAND Corp. study commissioned by the National Institutes of Health and released Friday calls into question the safety of ephedra.
The RAND study found that using ephedra is associated with higher risks of heart palpitations, tremors and insomnia.
Other studies have also suggested links to health problems.
The "Annals of Internal Medicine" reports this month that though products with ephedra make up less than 1 percent of dietary supplement sales, it has accounted for 64 percent of the serious side effects that have been reported to the Centers for Disease Control and Prevention in association with dietary supplements.
A second study published in the journal "Neurology" found that the rate of strokes among ephedra users was higher than in nonusers. The supplement users in the study took more than 32 milligrams a day; some ephedra labels recommend almost 100 milligrams daily.
The FDA doesn't regulate dietary supplements, but if a product is determined to pose a significant health risk, it can ban sales of the product.
FDA regulates synthetic ephedrine, which is identical to the active ingredient in ephedra and is found in some over-the-counter and prescription drugs. The FDA said these drugs carry mandatory warning labels and have not been associated with the severe side effects that ephedra herbal supplements have.