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The Food and Drug Administration has gathered information on 134 cases of
serious illness or death linked to the dietary supplement ephedra,
renewing its efforts to show that the popular energy-boosting and
fat-burning herbal extract can pose serious health risks.
The agency intends to publish the new data March 31, then hold
a public meeting to discuss the reports before taking further
action. The Washington Post examined a copy of the case
documents.
FDA officials have not made clear whether they intend to
resume their unsuccessful three-year quest to impose dosage
restrictions on ephedra products. Previous efforts have foundered
on the FDA's inability to satisfy Congress and the supplements
industry on the reliability of its case reports.
But it is clear from the new data that the agency tried to
document the cases thoroughly, with an eye on past objections:
that it failed to establish a causal link between ephedra and the
illness; that consumers deliberately overdosed themselves; and
that consumers ignored warnings about drug interactions and
pre-existing medical conditions.
In one case, a woman described in a letter how she had begun
taking Herbalife ephedra supplements and drinking Herbalife tea
on May 27, 1998, then went into cardiac arrest running the bases
after hitting a grand slam in a softball game:
"I had to be resuscitated four times," said the
woman, whose name and address were redacted from the report.
"In the emergency room doctors kept asking . . . if I was
using an inhaler," because "I was a perfectly healthy
28-year-old female."
The report said the woman consumed only the number of pills
recommended on the label--which was photocopied and filed with
the report. Eventually, doctors surgically implanted a
defibrillator to regulate her heartbeat.
Herbalife Senior Vice President Richard Marcotullio said he
had "absolutely no knowledge" of the case, that
Herbalife has "never been contacted by the FDA" and
that "we've got a very exemplary safety record."
Another report, several hundred pages long, documented a
massive brain hemorrhage suffered on a treadmill by a 29-year-old
soldier who had just graduated from college and was on his way to
officer training.
His Army career is over, his mother said, and "he may
never walk again." The man drank an ephedra-containing
beverage made with Ultimate Orange, a product that advertises
"one serving and you'll feel the difference." Next
Nutrition, the maker of Ultimate Orange, did not return telephone
calls seeking comment.
Ephedra, also known as ma huang, is an herb used in Asia as a
treatment for asthma. In the United States, synthetic ephedra is
an active ingredient in over-the-counter bronchial drugs.
Ephedra also is almost identical chemically to
methamphetamine. In one of the new FDA case studies, a
44-year-old woman was kicked out of the hospital between grand
mal seizures because doctors found amphetamines in her urine and
"accused her of being on drugs," the report said.
Since the FDA in 1993 established its Special Nutritionals
Adverse Event Monitoring System to receive voluntary reports of
illness and death from dietary supplements, ephedra products have
been the biggest source of complaints--685 between 1993 and
October 1998, including 39 deaths.
Those complaints sketch out a range of symptoms explored in
detail in the 134 new reports: tightness in the chest,
jitteriness and insomnia, as well as addiction, hypertension,
seizure, stroke and death.
In June 1997, the FDA proposed a new federal regulation
restricting dosages of ephedra to 8 milligrams per serving and 24
milligrams per day, limiting the treatment regime to one week,
and prohibiting blends of ephedra with natural caffeine products
such as guarana and cola nut.
The supplements industry widely attacked the agency proposal,
and Congress discounted the FDA's monitoring reports as sloppy,
incomplete and poorly documented.
In February 1999, the FDA conceded defeat on the rule,
withdrawing the dosage and duration recommendations, but it also
announced it would publish more information. The new data include
every ephedra complaint received by the agency between June 1,
1997, when the original rule was proposed, and March 31, 1999.
R. William Soller of the Consumer Healthcare Products Association, which represents
supplement manufacturers and distributors, was reluctant to comment
on the reports before seeing them. He noted that the FDA's 1997
proposal was closely screened by the industry, and "there will
be even more heightened scrutiny" this time. "Let's look
at the documents first."
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