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ADEC 204th meeting resolutions, 17 June 1999

Australian Drug Evaluation Committee

17 June 1999

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 204th (1999/4) Extraordinary Meeting of the Australian Drug Evaluation Committee (ADEC) resolved to advise the Parliamentary Secretary to the Minister for Health and Aged Care, and the Secretary, Department of Health and Aged Care, of the following safety related recommendation:

Resolution No 7704

At an extraordinary meeting held on 17 June 1999, the ADEC considered the risk to benefit ratio of the continued supply by Pfizer Pty Limited of Trovan and Trovan IV, in view of information regarding severe hepatic toxicity associated with Trovan and Trovan IV, and resolved to advise the Minister and the Secretary that:

  1. The use of Trovan film-coated tablets, containing trovafloxacin 100 mg and 200 mg, and Trovan IV sterile concentrated solution for injection, containing alatrofloxacin mesylate 5 mg/ml, should be restricted to the treatment of patients with at least one of the following infections:
    • Nosocomial pneumonia;
    • Community-acquired pneumonia;
    • Complicated intra-abdominal infections (including post-surgical infections);
    • Gynaecological and pelvic infections; or
    • Complicated skin and skin structure infections (including diabetic foot infections).
    With the following conditions:
    • where the infection is considered to be serious and life- or limb-threatening;
    • where other registered antibiotics are inappropriate; and
    • when the treating physician, after consulting with a clinical microbiologist/infectious disease specialist, believes that, given the new safety information, the benefit of the product for the patient outweighs the potential risk.
    Therapy should be restricted to 14 days duration and should be discontinued prior to 14 days should patients experience any clinical signs or symptoms of liver dysfunction and/or allergic symptoms. Exposure for longer than 14 days appears to be associated with a substantially increased risk of liver failure.
  2. Full consideration of the risk/benefit profile of Trovan/Trovan IV should be undertaken at the next ADEC meeting (August 1999).

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

July 1999