Ephedra Upper Limit Established

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    Ephedra Upper Limit Established


    Cantox Report Establishes Ephedra Upper Limit, Finds FDA
    AERs Unhelpful

    December 21, 2000 12:00am Source: F-D-C Reports, Inc.

    Up to 90 mg per day of ephedrine alkaloids, based on three
    daily doses of 30 mg, is the safe upper limit for intake at
    which no adverse events were observed, according to a Cantox
    Health Sciences International report released Dec. 20.

    'Based on the available scientific data, a [No Observed
    Adverse Event Level] of 90 mg/day of ephedrine alkaloids in
    ephedra' can be established, the report notes. The intake
    level was determined taking into account several studies,
    including eight conducted on ephedra efficacy in the obese
    from 1985 to 2000.

    The long-awaited Cantox report - 'Safety Assessment and
    Determination of a Tolerable Upper Limit for Ephedra' -
    comes after FDA had withdrawn its 24 mg/d and 8 mg per
    serving ephedrine alkaloid recommendation that was to be
    part of the ephedra proposed reg.

    The General Accounting Office raised concerns that the
    limits initially proposed by FDA were based on a small
    amount of questionable adverse event data.

    The Canadian firm's report - an analysis of clinical and
    non-clinical studies as well as animal and toxicological
    data - had been delayed for several months while researchers
    analyzed data from an obesity study led by Columbia
    University's Carol Boozer and Patricia Daly, MD, formerly of
    Harvard University.

    The Cantox report also sets a Lowest Observed Adverse Event
    Level of 150 mg/day, based on an evaluation of the same
    eight clinical studies of obese individuals. The LOAEL is
    the threshold at which any AE was observed.

    The report adds that most of the events experienced at those
    dosage levels in the referenced trials 'were expected,
    anticipated physiological responses to ephedrine.'

    With safety identified as the primary endpoint of the Cantox
    analysis, FDA's adverse event monitoring system also was
    factored into the writing of the report. However, the
    agency's AERs 'are not conclusive and therefore are not an
    adequate basis for identifying appropriate limits,'
    according to a Dec. 20 letter to FDA from the Council for
    Responsible Nutrition.

    CRN, which sponsored the Cantox study, reiterates doubt as
    to the utility of the agency's AERs. 'Many contain little
    information of reliable quality. Others lack critical
    information needed for any possible assignment of
    causality,' the association noted. 'Reliable dosage
    information is missing from most.'

    Additionally, CRN found many AERs may be misleading based on
    existing conditions of patients and intake of other
    substances. 'The overall rate of adverse effects is low,
    considering the amount of ephedra sold and consumed' in the
    U.S., the council concluded.

    CRN's interpretation of FDA's AERs run counter to an
    analysis published by University of California at San
    Francisco researchers in the Dec. 21 New England Journal of
    Medicine.

    Christine Haller, MD, and Neal Benowitz, MD, found that
    although the reliability of self-reported AEs raise
    questions, 87 of 140 adverse events included in the agency's
    database 'definitely,' 'probably' or 'possibly' were related
    to use of ephedrine alkaloid supplements. The USCF
    researchers urged prompt regulatory action due to the
    'severity' of the AEs.

    The Cantox report places particular emphasis on the recently
    completed Harvard/Columbia clinical trial conducted by
    Boozer et al., largely basing the 90 mg/d ephedrine
    alkaloids intake on their study protocol and findings.

    The study found supplements containing ephedra and caffeine
    were efficacious in promoting loss of body weight and body
    fat in healthy obese subjects, with only 'transient
    increases in blood pressure and heart rate,' Boozer
    commented at a Dec. 20 press conference releasing the Cantox
    data. FDA remains opposed to combination supplements
    containing ephedrine and caffeine.

    CRN asks that the Cantox report be added to the public
    comments accepted by FDA in concluding a final rule on
    ephedra supplements. The Dec. 20 submission of the data
    comes after the agency first moved the comment deadline from
    May 18 to July 3, then to Sept. 30.

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    This now means the average idiot has a reference point.  I realy took 10 caps a day but ill only say I took the 3  im suppose to.  just like "steroids??" I only used a un-named protien supplemnt. good ole' E is still not off the hook yet. Atleast educated consumers have a idea of where to start. lets see iff it makes the news like the initial E scare.  I bet it wont.
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    yeah, doubtful, but good info and important nonetheless. thanks sheesh
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    I thought I had read some where that the upper limit was 100mg a day to be safe with no adverse sides. Thanks for the post man.

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