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ADEC 195th meeting resolutions, 5-6 February 1998

Australian Drug Evaluation Committee

5 February 1998

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 195th (1998/1) Meeting of the Australian Drug Evaluation Committee (ADEC) (5-6 February 1998) resolved to advise the Parliamentary Secretary to the Minister for Health and Family Services, and the Secretary, Department of Health and Family Services, that the following drugs should be approved for registration, subject to the resolution of all outstanding matters to the satisfaction of the Committee and the Therapeutic Goods Administration. These recommendations for approval may be subject to specific conditions.

MONTELUKAST (as sodium) Singulair chewable tablets 5 mg
MONTELUKAST (as sodium) Singulair film coated tablets 10 mg
Merck Sharpe & Dohme (Australia) Pty Ltd
Indications: For the prophylaxis and treatment of asthma in adults and children over 6 years.

FINASTERIDE Propecia film coated tablets 1 mg
Merck Sharpe & Dohme (Australia Pty Ltd)
Extension of Indications: The treatment of male pattern hair loss (androgenic alopecia) to increase hair growth and prevent further hair loss in men aged 18 years or older.

CIDOFOVIR (anhydrous) Vistide sterile concentrate for IV infusion 75 mg/mL
Pharmacia & Upjohn Pty Limited
Indications: For the treatment of cytomegalovirus (CMV) retinitis in patients aged 12 years or over with Acquired Immunodefiiency Syndrome (AIDS).

HUMAN PROTHROMBIN COMPLEX Prothrombinex-HT freeze dried powder (factor IX 500 IU/vial, factor II approximately 500 IU/vial, and factor X approximately 500 IU/vial)
CSL Limited
Indications: Prophylaxis and treatment of bleeding in patients with single or multiple congenital deficiency of factor IX, II or X and in patients with single or multiple acquired prothrombin complex factor deficiency requiring partial or complete reversal (e.g. reversal of warfarin anti-coagulant therapy).

NARATRIPTAN (as HCl) Naramig film coated tablets 2.5 mg
Glaxo Wellcome Australia Ltd
Indications: For the acute treatment of migraine attacks with or without aura in adults.

TRAMADOL (as HCl) Tramal sterile solution for injection 50 mg/mL
TRAMADOL (as HCl) Tramal capsules 50 mg
Covance Pty Ltd (on behalf of CSL Limited)
Indications: For the relief of moderate to severe pain.

LEVONORGESTEREL/ETHINYLOESTRADIOL Loette fixed dose combination film coated tablets 100 µg/20 µg
Wyeth Australia Pty Limited
Indications: For the prevention of pregnancy.

ABCIXIMAB Reopro sterile solution for injection 2 mg/mL
Eli Lilly Australia Pty Limited
Amendment of Dosage Schedule and Indications: Reopro is indicated for: percutaneous coronary intervention: the prevention of ischaemic cardiac complications in patients undergoing percutaneous coronary intervention (balloon angioplasty, atherectomy and stent placement). Reopro is intended for use with aspirin and heparin and has been studied only in that setting.

EPROSARTAN (as mesylate) Teveten tablets 200 mg, 300 mg and 400 mg
SmithKline Beecham (Australia) Pty Ltd
Indications: For the treatment of essential hypertension.

ISOSORBIDE MONONITRATE Imtrate modified release tablets 60 mg
ISOSORBIDE MONONITRATE Imsorb modified release tablets 60 mg
Douglas Pharmaceuticals (Imtrate)
Merck Sharpe & Dohme (Australia) Pty Ltd (Imsorb)
Indications: For the prophylactic treatment of angina pectoris. Imtrate (Imsorb) tablets are not recommended for the managment of acute attacks of angina pectoris.

YELLOW FEVER VACCINE (LIVE), STABILISED Stamaril freeze dried lyophilised power for reconstitution of solution for injection 1000 U/0.5 mL
CSL Limited
Indications: For the prevention of yellow fever.

CIPROFLOXACIN (as HCl) Ciproxin film coated tablets 250 mg, 500 mg and 750 mg
Bayer Australia Ltd
Extension of Indications: The treatment of chronic bacterial prostatitis of mild to moderate severity due to susceptible micro-organisms.

SALBUTAMOL (as sulfate) Ventolin Inhaler Complete CFC-Free powder
for inhalation 100 µg/actuation
Glaxo Wellcome Australia Ltd
Indications: For the relief of bronchospasm in patients with asthma or chronic obstructive pulmonary disease, and for acute protection against exercise-induced asthma and other stimuli known to induce bronchospasm.

ATOVAQUONE/PROGUANIL HCl Malarone fixed combination tablets 250 mg/100 mg
Glaxo Wellcome Australia Ltd
Indications: For the treatment of Plasmodium falciparum malaria in adults and children aged 3 years or older.

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The ADEC also resolved to advise the Minister and the Secretary on the following safety related issues, that:

RESOLUTION NO 7384

THE ADEC SUPPORTS MEASURES RECOMMENDED BY THE CORONER TO AVOID THE INCORRECT PRESCRIBING AND USE OF METHOTREXATE FOR THE TREATMENT OF RHEUMATOID ARTHRITIS. IN PARTICULAR, RECOMMENDATIONS 3 AND 6 AS FOLLOWS ARE SUPPORTED:

RECOMMENDATION 3: 'A PRESCRIBER'S DIRECTIONS FOR TAKING ORAL METHOTREXATE WEEKLY, SHOULD NOMINATE A SPECIFIC DAY OF THE WEEK, PREFERABLY A DAY OF SOME SIGNIFICANCE TO THE PATIENT'.

RECOMMENDATION 6: 'THAT ALL MANUFACTURERS OF ORAL DOSE FORMS OF METHOTREXATE WEEKLY, SHOULD ENSURE THE READY AVAILABILITY OF PATIENT INFORMATION....'

TO FURTHER ASSIST IN THIS MATTER, THE ADEC RECOMMENDS THAT THE TGA SHOULD PURSUE THE FOLLOWING OPTIONS:

  • UPDATING OF ALL EXISTING METHOTREXATE CMI AND PI DOCUMENTS TO INCLUDE CLEAR DOSAGE DIRECTIONS AND PRECAUTIONS FOR EACH OF THE APPROVED INDICATIONS;
  • CONTACTING THE PUBLISHERS OF MIMS BIMONTHLY TO REQUEST THE INCLUSION OF CLEAR INFORMATION ABOUT WEEKLY DOSING OF METHOTREXATE FOR RHEUMATOID ARTHRITIS;
  • CANVASSING THE VIEWS OF THE PBAC AS TO THE ECONOMIC FEASIBILITY OF A SMALLER PACK SIZE OF METHOTREXATE FOR THE INDICATION OF RHEUMATOID ARTHRITIS;
  • TARGETED PUBLICITY IN MEDICAL/PHARMACEUTICAL 'POPULAR' PRESS AND MEDICAL/PHARMACEUTICAL DEFENCE ASSOCIATION NEWSLETTERS;
  • A LETTER TO THE RHEUMATOLOGY ASSOCIATION REQUESTING THAT THEY BRING THIS ISSUE TO THE ATTENTION OF MEMBERS;

THE ADRAC SHOULD ALSO CONSIDER WHETHER THIS ISSUE WARRANTS THE INCLUSION OF A BOXED WARNING IN METHOTREXATE PI DOCUMENTS.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

17 February 1998

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