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CMEC Meeting 58, 16 August 2006

Complementary Medicines Evaluation Committee

16 August 2006

Extracted ratified minutes

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CMEC Meeting 58 extracted ratified minutes (pdf,110kb)

Public recommendation summary

This summary has been posted immediately after the CMEC meeting to give quick advice of the recommendations made by CMEC to the TGA. This summary does not represent the decisions of TGA. Reasons underlying these recommendations will be available after Members ratify the Minutes at the next CMEC meeting.

Item 2 Confirmation of Draft Minutes of CMEC 57 (9 June 2006)

Recommendation 58.1

CMEC confirms that the draft Minutes of its previous meeting (CMEC 57, 9 June 2006), are a true and accurate record of that meeting.

Item 4.1 Plant part project - Herbal materials with potential safety issues

Recommendation 58.2

CMEC recommends that a working group be established to review the safety of certain herbal materials for continued use in Listed medicines.

Item 6.1 Evaluation of New Substances - Omega-3-marine triglycerides

Recommendation 58.3

CMEC recommends to the TGA that omega-3-marine triglycerides (British Pharmacopoeia) is suitable for use as an ingredient in oral Listed medicines.

Item 7.1 Safety or Efficacy Reviews - Hydroxyanthracene derivatives

CMEC, having considered a safety review of ingredients permitted in Listed medicines that contain hydroxyanthracene derivatives, makes the following recommendations to the TGA:

Recommendation 58.5.1

That existing regulatory arrangements for ingredients used in Listed medicines that contain hydroxyanthracene derivatives are appropriate, including the current labelling requirements, namely:

  1. For all products making a laxative claim and with a daily dose of 10 mg or more derived from hydroxyanthracene derivatives:
    • 'Drink plenty of water' (or words to that effect)
    • 'Prolonged use may cause serious bowel problems' (or words to that effect)
    • 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek health practitioner advice before taking this product.' (or words to that effect)
    • 'Use in children under 12 years is not recommended'
    • 'If symptoms persist consult your health care practitioner' (or words to that effect)
  2. For all products NOT making a laxative claim and with a daily dose of 10 mg or more derived from hydroxyanthracene derivatives:
    • 'Prolonged use may cause serious bowel problems' (or words to that effect)
    • 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek health practitioner advice before taking this product.' (or words to that effect)
    • 'This product may have a laxative effect'
    • 'This product contains [name of herb(s) or chemical component(s)].'
    • 'Use in children under 12 years is not recommended'
    • 'If symptoms persist consult your health care practitioner' (or words to that effect)
  3. For all products making a laxative claim and with a daily dose of less than 10 mg derived from hydroxyanthracene derivatives:
    • 'Drink plenty of water' (or words to that effect)
    • 'Prolonged use may cause serious bowel problems' (or words to that effect)
    • 'Use in children under 12 years is not recommended''If symptoms persist consult your health care practitioner' (or words to that effect)
  4. For all products NOT making a laxative claim and with a daily dose of less than 10 mg derived from hydroxyanthracene derivatives:
    Label warnings as required by other ingredients in the product.

Recommendation 58.5.2

That The Guidelines for Oral Products Containing Hydroxyanthracene Derivatives be incorporated into the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) as an adjunct guideline.

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