FDA issues warning label on ephedra
Labels indicating risks of heart attacks, seizures or death will now be required for all products containing the herbal supplement ephedra, the U.S. Food and Drug Administration announced last Friday.
The decision follows the death of Baltimore Orioles prospective pitcher Steve Bechler on Feb. 17 that was linked to the use of a supplement containing ephedra. Major League Baseball decided this week to ban ephedra use in its minor league divisions in light of his death.
The National Football League, the International Olympic Committee and the National Collegiate Athletics Association already prohibit the use of ephedra.
“We want to caution all Americans – particularly athletes and those who engage in strenuous activities – about using dietary supplements that contain ephedra,” said Health and Human Services Secretary Tommy Thompson in a written statement. “There continues to be serious questions about the risks surrounding this particular dietary supplement.”
Ephedra as an herbal supplement is often found in many over-the-counter products designed to help lose weight, enhance sports performance and increase energy.
The FDA said there was an increased risk for users of ephedra who are under the age of 18, exercise frequently or use caffeine or other stimulants. They added that health problems were not only limited to those who had extended use of ephedra – indicating it could cause problems with first-time users.
A recent study released by RAND Corp., a government-funded think tank, shows that using ephedra can lead to higher risks of heart palpitations, tremors and insomnia. The FDA said the RAND report also finds only limited evidence of the health benefits of the herbal supplement.
A study released last week reviewed more than 16,000 adverse events reports involving ephedra, including two deaths, four heart attacks, nine strokes, one seizure and five psychiatric cases, said American Medical Association Trustee Ron Davis in a written statement.
The warning label will “lay the legal groundwork needed for further regulatory restrictions,” FDA Commissioner Mark McClellan said in a written statement.
Under the Dietary Supplement Health and Education Act of 1994, the FDA does not review dietary supplements for safety and efficacy before they go on the market. But they reserve the power to take the drug off the market if it presents a significant risk.
The FDA regulates synthetic ephedrine found in some prescription drugs and over-the-counter drugs such as nasal decongestants. It is the same substance as the active ingredient in ephedra, but the FDA said synthetic ephedrine has proven benefits and carries mandatory warning labels and has not been shown to have the same severe side effects as the ephedra herbal supplement.