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FDA Articles Sited in
the ephedra ban![[Dividing Line Image]](images/div.gif)
Articles sited in
the ephedra ban specifically mentioning ephedra
Summary
Findings (source):
-
Efficacy for Weight Loss
Evidence supports an association between short-term use of ephedrine,
ephedrine plus caffeine, or dietary supplements that contain ephedra with or
without herbs containing caffeine and a statistically significant increase
in short-term weight loss (compared to placebo). Adding caffeine to
ephedrine modestly increases the amount of weight loss. There is no evidence
that the effect of ephedra-containing dietary supplements with herbs
containing caffeine differs from that of ephedrine plus caffeine: Both
result in weight loss that is approximately two pounds per month greater
than that with placebo, for up to four to six months.
-
Efficacy for Physical Performance Enhancement
Data supports a modest effect of ephedrine plus caffeine on very short
term athletic performance.
-
Safety Issues
A causal relationship between ephedra or ephedrine use and serious adverse
events cannot be assumed or proven. Evidence from controlled trials was
sufficient to conclude that the use of ephedrine and/or the use of
ephedra-containing dietary supplements or ephedrine plus caffeine is
associated with two to three times the risk of nausea, vomiting, psychiatric
symptoms such as anxiety and change in mood, autonomic hyperactivity, and
palpitations. Identified 43 additional cases as possible sentinel events
with prior ephedra consumption and seven additional cases as possible
sentinel events for prior ephedrine consumption. About half the sentinel
events occurred in persons aged 30 years or younger. Classification as a
sentinel event does not imply a proven cause and effect relationship.
-
Future Research
Long-term assessments of the effectiveness of herbal ephedra or ephedrine
for promoting weight loss are lacking. No study was found with a treatment
duration longer than six months. The benefit of ephedrine or herbal
ephedra-containing dietary supplements for health outcomes is unknown.
Evidence regarding the effect of herbal ephedra or ephedrine on physical
performance that reflects its use in the general population (repeated or
long-term use by a representative sample) is also needed. In order to assess
a causal relationship between ephedra or ephedrine consumption and serious
adverse events, a hypothesis-testing study is needed. Continued analysis of
case reports cannot substitute for a properly designed study to assess
causality. A case-control study would probably be the study design of
choice.
FDA
- Evidence On The Safety And Effectiveness Of Ephedra: Implications For
Regulation
Report
of Ephedra Working Group to the National Advisory Council for Complementary and
Alternative Medicine
Addresses evidence regarding the safety and efficacy of ephedra for
weight loss and for enhanced athletic performance and suggests new studies
The
CANTOX Report on Ephedra from the Council for Responsible Nutrition
A 2000 prepared report finding ephedra both safe and beneficial for weight loss
at 90mg per day
Preponderance
of Evidence Judging What to Do About Ephedra - Rand study Spring 2003
Adverse
Event Reports from Metabolife - U.S. House of Representatives report
Ephedra
Warning Letters - list of ephedra manufacturers and distributors targeted by
the FDA
Warning
letter sent to the above firms on February 28, 2003
Washington
Post Article, January 14, 2003: Ephedra Products Thin Out Braced for the Worst,
Makers Sell New Herbs
Correction:
The Relative Safety of Ephedra Compared with Other Herbal Products - Annals
of Internal Medicine Online
The
Relative Safety of Ephedra Compared with Other Herbal Products Dickinson Ann
Intern Med.2003; 139: 385 - Annals of Internal Medicine Online
Washington
Post Article, July 23, 2000: Ephedra Lawsuits Show Big Increase
Washington
Post Article, February 8, 2001: Woman Wins $13.3 Million Against Dietary Company
Other Articles Sited in
the ephedra ban
Guidance
for Industry Botanical Drug Products - being distributed for comment
purposes only
Guidelines
for Ensuring the Quality of Information Disseminated to the Public
Initiation
and Conduct of All 'Major' Risk Assessments within a Risk Analysis Framework
Guidance
for Industry Significant Scientific Agreement in the Review of Health Claims for
Conventional Foods and Dietary Supplements
Stedman's
Medical Dictionaries
Guidance
for Industry Street Drug Alternatives
Facts
and Comparisons website
Clinical
Guidelines on the Identification, Evaluation, and Treatment of Overweight and
Obesity in Adults
http://www.laegemiddelstyrelsen.dk/en/news/letigen_6_en.asp
- report from the Danish Medicines Industry
Detection,
Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment
Panel III)
Guidance
for Industry S7A Safety Pharmacology Studies for Human Pharmaceuticals
"Dear
Colleague" letter regarding the Research on Eosinophilia-Myalgia Syndrome
and Current Regulatory Status of L-Tryptophan
Regulatory
Analysis Circular A-4, September 17, 2003 - OMB, The Executive Office of the
President of the USA
Life
Expectancy - CDC - National Center for Health Statistics
HCUPnet
- Database selection - Healthcare Cost & Utilization Project (HCUP)
National
Nutritional Food Association - NNFA
Dietary
Supplement Sales Database - The Food Safety Risk Analysis Clearinghouse
Survey
of Manufacturing Practices in the Dietary Supplement Industry - The Food
Safety Risk Analysis Clearinghouse
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