Severe Health Risks Associated with Ephedra-Containing Dietary Supplements

Strategic Insights -

A recent study published in the December 21, 2000, issue of The New England Journal of Medicine has raised alarming concerns about the safety of popular dietary supplements containing Ephedra. Researchers at the University of California, San Francisco (UCSF) have concluded that these products can pose severe health risks, including death, permanent injury, and on-going medical treatment. The study analyzed 140 reports of adverse effects from ephedrine-containing supplements received by the U.S. Food and Drug Administration (FDA) and found that 31% of the cases were definitely or probably related to ephedra.

Key Takeaways:

  • Of the 140 reports analyzed, 43 people "definitely" or "probably" suffered an adverse effect from ephedrine in a dietary supplement, with 3 deaths, 7 permanent injuries, and 4 ongoing medical treatments.
  • Serious effects among these people included 5 cardiac arrests, 4 strokes, and 10 cases of hypertension.
  • When a second group was included in the analysis, the number of deaths rose to 10 out of 87 people, and permanent disabilities rose to 13 out of 87.
  • The researchers estimate that adverse effects are widely believed to be underreported by 10-fold or more.
  • The authors call for large-scale, controlled studies to quantify the dangers of ephedrine-containing products and to identify who is vulnerable to the serious side effects.
  • They also urge the FDA to impose more uniform, mandatory labeling of contents and quantities.
  • Most ephedrine-containing products are derived from the herbal plant ma huang and often contain caffeine derived from guarana, which can increase the risk of severe side effects.
  • The researchers suspect that the people who should avoid ephedrine-containing supplements are those with kidney disease, pre-existing heart disease, hypertension, over-active thyroid, psychiatric disorders, autonomic insufficiency, and histories of seizures and diabetes.

Statistics:

  • 12 million people in the U.S. use ephedrine-containing dietary supplements.
  • 3 billion servings of these supplements were sold in 1999.
  • 31% (43 out of 140) of adverse effect reports were definitely or probably related to ephedra.
  • 10 deaths and 13 permanent disabilities were reported among those who used ephedra-containing supplements.
  • The number of people under 18 who used ephedra-containing supplements was 7%.
  • The research was supported by funds from the U.S. Food and Drug Administration, the National Institute on Drug Abuse, and the U.S. National Institutes of Health.

Sources:

  • The New England Journal of Medicine, December 21, 2000.
  • Federal Register, April 3, 2000;65(64).
  • www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm.
  • Medical Letter on the CDC & FDA, November 12, 2000.