WASHINGTON
(Reuters) - To millions of Americans, the herb ephedra is an attractive,
over-the-counter option for trying to shed unwanted pounds. But
to critics, the product is a dangerous stimulant with unpredictable
consequences.
Manufacturers
and U.S. regulators have battled for years over whether ephedra,
an ingredient in dietary supplements for weight loss or boosting
energy, causes serious harm in rare cases. Tuesday, both sides
face off again at a public meeting to discuss whether ephedra
can be linked to problems such as heart attacks or strokes.
A panel of
experts hired by ephedra makers launched a preemptive strike Monday
by announcing its review of nearly 1,200 ``adverse events'' in
patients taking ephedra products. The reports were submitted to
the Food and Drug Administration over several years.
After reviewing
the FDA reports as well as other published literature, the panel
concluded the information did not show a link between the herb
and serious health problems if the products were taken according
to standards set by top makers.
``Available
information does not demonstrate an association between the use
of dietary supplements containing (ephedra) and serious adverse
events'' when used as directed, said Dr. Stephen Kimmel, a University
of Pennsylvania epidemiologist who has studied drugs' effects
on the heart.
Panel members
acknowledged the FDA reports were hard to evaluate. Nearly three-quarters
contained incomplete information. Many involved people who ignored
manufacturers' directions, including a warning to take no more
than 100 milligrams of ephedra per day, the panel said.
Some say ephedra,
also listed on product labels as ma huang, can be dangerous even
if taken according to industry standards. Because ephedra is a
stimulant, critics say it can dangerously speed up heart beats
and raise blood pressure.
Dr. Michael
Hoffstetter, a Virginia neurologist, treated a 24-year-old woman
who showed up at an emergency room suffering from a stroke that
left her right side completely paralyzed. The woman had been taking
an ephedra product for one month in order to lose some weight
before her wedding, said Hoffstetter, who blames ephedra for the
stroke.
``I really
have no other reason for a 24-year-old healthy young woman to
have a stroke,'' Hoffstetter said in an interview. ``She was taking
the diet pills within their labeling. She was on them for about
a month and really had no warning of this.''
In response
to concerns, the Food and Drug Administration in 1997 proposed
capping ephedra dosages at 8 milligrams per serving and warning
consumers to take only 24 milligrams daily for up to seven days.
The FDA withdrew
its proposed restrictions last March after the industry and congressional
investigators charged it did not have sound scientific evidence
to support them.
Now, FDA officials
say they are starting over with a new review of ephedra's safety.
The agency has collected 273 new reports on people taking ephedra
and is scheduled to present its evaluation Tuesday.
``We're kind
of starting from square one to see if we can get more scientific
backing for what we might do in the future,'' an FDA official
said.
Despite controversy
over ephedra, the supplement's popularity has been growing since
1995. Makers say three billion servings were sold last year and
estimate that anywhere from four million to 15 million Americans
take ephedra products.
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