| FOR IMMEDIATE RELEASE
CONTACT: Robert S. McCaleb
Review of Ephedra Adverse Events Scheduled for Publication
November 6, 2000: The New England Journal of Medicine
has released the results of an independent review of 140 adverse
event reports (AERs) possibly related to ephedra dietary supplements.
The report, scheduled for publication in the December 21 issue
of NEJM, was posted online in advance of its scheduled
publication date because of its "potential public health
The AERs examined by the authors of the review were filed with
the FDA between June 1, 1997 and March 31, 1999. Based on their
review, the study authors concluded that "
that contain ephedra alkaloids may pose a health risk to some
persons" and that their findings "indicate the need
for a better understanding of individual susceptibility to the
adverse effects of such dietary supplements." They reported
that 69 percent of the AERs were unrelated or only possibly related
to the use of ephedra-containing products. For people who did
experience side effects, the authors propose that variations in
individual sensitivity to ephedrine alkaloids, concomitant use
of caffeine, pre-existing medical conditions, or manufacturing
inconsistencies may have been a factor in the adverse events.
Recognizing this need years ago, the dietary supplement industry
voluntarily adopted labeling intended to warn specific populations
of consumers to avoid the ephedra-containing products, or to consult
their physicians first. The label warning recommended by the American
Herbal Products Association (AHPA) reads:
Not intended for use by anyone under the age of 18. Do not
use this product if you are pregnant or nursing. Consult a health
care professional before using this product if you have heart
disease, thyroid disease, diabetes, high blood pressure, psychiatric
condition, difficulty in urinating, prostate enlargement, or
seizure disorder, if you are using a monoamine oxidase inhibitor
(MAOI) or any other prescription drug, or you are using an over-the-counter
drug containing ephedrine, pseudoephedrine or phenylpropanolamine
(ingredients found in certain allergy, asthma, cough/cold and
weight control products).
Based on another recommendation from AHPA, many manufacturers
also have adopted labeling that recommends limiting intake of
ephedrine alkaloids to 25mg per serving, with daily intake not
to exceed 100mg. In addition, these labels indicate the quantity
of ephedrine alkaloids per serving. On October 26, 2000, four
industry trade associations petitioned FDA to adopt these requirements
as the federal standard so that all manufacturers would be compelled
to label their products this way. HRF supports the adoption of
the requirements, a step that would help educate consumers about
the appropriate use of ephedra and prevent overdose, misuse, and
abuse of ephedra products.
Pseudoephedrine (an ephedra-derived alkaloid) is an active ingredient
of FDA-approved over-the-counter cold medications such as Sudafed®.
Ironically, FDA nonprescription drugs chief Dr. Charles Ganley
has suggested that consumers substitute products like Sudafed
for over-the-counter cold products containing phenylpropanolamine
(PPA), which were recently pulled from the market by FDA.
Haller CA, Benowitz NL. Adverse cardiovascular and central nervous
system event associated with dietary supplements containing ephedra
alkaloids. New England Journal of Medicine; scheduled for
publication December 21, 2000