|
 "The number of poisonings resulting in major effects or deaths has
decreased by more than 98% since 2002. The 2004 FDA ban has proved
to be a very effective means of limiting the availability of ephedra
and therefore its potential toxicity in the United States," Illinois
researchers report in the May 28 New England Journal of Medicine.
It was the first dietary supplement to be banned.
"I used to see patients with a lot of ephedra problems in the late
1990s and early 2000s. I haven't seen one literally in 10 years,"
coauthor Dr. Jerrold Leikin, director of toxicology at NorthShore
University HealthSystem in Evanston told Reuters Health in a
telephone interview.
"It's the eradication -- you can almost use that word -- of this
substance within a relative short period of time -- a few years," he
said. "It was expected, but the extent is quite surprising. And
remember, this was not a drug. This was an over-the-counter dietary
supplement. There's been very few studies looking at the effect of
an FDA ban on dietary supplements."
Ephedra, also known as ma huang, was the chief ingredient in many
weight-loss and energy-enhancement products in the U.S. The herb was
known to produce modest short-term weight loss but it was killing
people.
It has been linked to heart attack, stroke, seizure, high blood
pressure, and heart rhythm problems. It was held responsible for the
death of Baltimore Orioles pitching prospect Steve Bechler in 2003.
It was especially dangerous when used in conjunction with caffeine.
The ban was implemented in April 2004, overturned by the industry in
2005 but ultimately upheld by the U.S. Court of Appeals in 2006.
Prior to the ban, industry groups were saying the substance had been
used by 12 million people.
Using data from the National Poison Data System, the researchers
found that ephedra poisonings peaked at 10,326 in 2002 and then
began a significant decline to 180 by 2013.
Major effects, defined as hospitalization usually requiring critical
care, peaked the same year, at 108, one year after the system began
collecting ephedra data. By 2008, such reports were down to three or
fewer per year.
The number of deaths peaked later -- at seven in 2004. There had
been five, three and six the previous years. After the ban, there
was one death in 2005 and 2007. There were none in 2006 and in the
years after 2007.
[to top of second column] |
"What kind of surprised us was the near-completeness of the decrease
in toxicity, how it went from 8,000 to 10,000 down to literally a
few dozen calls to the poison center," Dr. Leikin said.
He speculated that the initial declines seen just before the ban
went into effect could have been the result of natural fluctuations
in the number of poisonings and major effects.
Dr. Stephen Barrett, a retired psychiatrist who has been following
the dietary supplement industry for decades, said he was please to
see evidence "that action by the FDA has reduced the harm caused by
an herbal product."
Unfortunately, said Dr. Barrett, who operates the Quackwatch.org,
website, the FDA's "ability to act quickly and to ban other
dangerous products has been severely crimped by the 1994 Dietary
Supplement Health and Education Act. This awful law classifies
herbal products as dietary supplements and prevents the FDA from
banning them without proof that they have caused deaths and/or
serious injuries. That’s backwards."
He said "the law should require that herbal products sold for
alleged health purposes be proven safe and effective BEFORE
marketing."
SOURCE: http://bit.ly/1AmGkvY
N Engl J Med 2015
[© 2015 Thomson Reuters. All rights
reserved.] Copyright 2015 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
 |
