E-drug: Ephedra ban
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5 September 2001
Public Citizen Calls on FDA to Ban Dietary Supplements Containing
Ephedra
Supplements With Ephedra Are Among the Most Deadly, Data
Show
WASHINGTON, D.C. - The U.S. Food and Drug Administration
(FDA) should ban the production and sale of dietary supplements
containing ephedra because they increase the risk for hypertension,
stroke, heart attacks and seizures, Public Citizen said today in a
petition submitted to the FDA. In fact, data indicate that they are
the most lethal of all dietary supplements.
Public Citizen is seeking the ban of all supplements containing
"ephedrine alkaloids," which include ephedra, ephedra extract,
ma-huang and other related compounds. While the FDA is
considering the petition, the FDA should warn people not to use
supplements that contain ephedra and these related substances, as
the Canadian government has recently done, Public Citizen said.
The petition was also signed by Dr Raymond Woosley, a noted
cardiovascular clinical pharmacologist who has consulted for the
FDA on the cardiac toxicity of ephedra alkaloids. A copy of the
petition is available at
http://www.citizen.org/hrg/publications/1590.htm
"These herbal supplements are marketed as being all-natural and
safe, but in reality they are not safe. They can harm and kill," said
Dr Sidney M. Wolfe, director of Public Citizen's Health Research
Group.
Supplements containing ephedra and related compounds are
commonly marketed as weight-loss aids, energy boosters and
performance enhancers. They are particularly popular among dieters
and athletes and are often targeted at young people. Despite
limitations of the 1994 Dietary Supplement Health and Education
Act, the FDA can ban ephedra products if the agency determines
that they present "a significant or unreasonable risk of illness or
injury under conditions of use suggested or recommended in the
labeling" or "under ordinary conditions of use."
FDA records obtained by Public Citizen indicate that supplements
containing ephedra are the most deadly of all supplements. An FDA
analysis of its database, which contains voluntary reports from
public health agencies, consumers and health professionals of
adverse events related to nutritional supplements, shows that
between January 1993 and February 2000, supplements containing
ephedra and related compounds were associated with more reports
of deaths, heart attacks, cardiac arrhythmias, hypertension, strokes
and seizures than all other dietary supplements combined.
Of the 3,308 adverse events analyzed, 1,398 were associated with
ephedra and related substances, or 42 percent. Of those, there
were 81 deaths, 32 heart attacks, 62 reports of cardiac arrhythmia,
91 reports of hypertension, 69 strokes and 70 seizures. Ephedra is
also associated with sleep disturbance, personality disorders,
agitation, headaches, hallucinations, gastrointestinal problems and
skin eruptions.
Additional data show a sharp increase in adverse events associated
with ephedra- containing supplements. A second FDA analysis, this
one of data collected by the American Association of Poison
Control Centers, shows that the number of adverse event reports
associated annually with ephedra supplements are on the rise, from
211 in 1997 to 407 in 1999.
Given the fact that the data comes from voluntary reports, it is
likely that the real numbers are much higher than either of the
above sources would suggest, Wolfe said. For example, the Texas
Department of Health reported approximately 500 adverse events
related to ephedra between December 1993 and September 1995.
"The fact that in under two years a single state could collect over a
third as many ephedra adverse event reports as [the FDA] has
gathered between 1993 and February 2001 speaks to the pitiful
inadequacy of reports to the current FDA system," the petition
says.
Health Canada, the Canadian equivalent of the Department of
Health and Human Services, in June issued a public advisory
warning people not to use products containing ephedra. The
Canadian agency based its warning in part on the FDA's data.
"Just adding warnings to the products' labels is not enough,"
Woosley said. "I support the call for a ban of these products
because there have been too many patients who followed the
instructions, read the warnings and still suffered strokes or heart
attacks."
Sidney M.Wolfe M.D.
Director, Public Citizen's Health Research Group
1600 20th St. NW, Washington, DC. 20009, USA
202 588-7735 fax 588-7796
e-mail: swolfe@citizen.org
Web site: www.citizen.org/hrg
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