Adverse drug reactions

The August and October 2004 issues of the Australian Adverse Drug Reactions Bulletin <http://www.tga.gov.au/adr/aadrb.htm> are available.

Articles in the August 2004 <http://www.tga.gov.au/adr/aadrb/aadr0408.htm> issue include:

• Cardiac valvulopathy with pergolide
• Clopidogrel - haemorrhage and haematological disorders
• Pulmonary toxicity with long-term nitrofurantoin
• Tramadol-warfarin interaction

Articles in the October 2004 <http://www.tga.gov.au/adr/aadrb/aadr0410.htm> issue include:

• Australian experience with pneumococcal conjugate vaccine
• Warnings for high dose tricyclic antidepressants
• Terbinafine and blood dyscrasias
• Cholinesterase inhibitors and cardiac arrhythmias
• Quinine indications - cramps deleted

ADEC update

Recommendations from the Australian Drug Evaluation Committee's 234th (June 2004) <http://www.tga.gov.au/docs/html/adec/adec0234.htm> and 235th (August 2004) <http://www.tga.gov.au/docs/html/adec/adec0235.htm> meetings are available.

ARGCM

The final versions of Parts I, II, IV and V of the Australian Regulatory Guidelines for Complementary Medicines <http://www.tga.gov.au/docs/html/argcm.htm> (ARGCM) are now available.

CMEC update

The public recommendation summaries for the 46th (June 2004), 47th (August 2004) and 48th (October 2004) meetings of the Complementary Medicines Evaluation Committee and the extracted ratified minutes of the 44th (February 2004) meeting are available.

CMEC public recommedation summaries & extracted ratified minutes <http://www.tga.gov.au/docs/html/cmec/cmecminu.htm>

ELF news

A new document Guidance on Product Changes in ELF3 <http://www.tga.gov.au/cm/elf3productchanges.htm> is now available.

The List of proprietary ingredients which have been used in Listed medicines but which are not usable in ELF 3 until further information is provided <http://www.tga.gov.au/cm/elf3pring.htm> has been updated, as has Substances that may be used as active ingredients in 'Listed' medicines in Australia <http://www.tga.gov.au/cm/listsubs.htm>.

EU guidelines

European Union (EU) Guidelines adopted by the TGA are sourced from the Committee for Proprietary Medicinal Products (CPMP) and International Conference on Harmonisation (ICH).

Since the last issue of TGA News, twenty-three EU guidelines have been adopted in Australia, five have not been adopted and three have been replaced/superseded.

• European Guidelines - Newly Published <http://www.tga.gov.au/docs/html/euguideh.htm#eugwnp>

Exporting medicines

Some of the documents and forms relating to exporting medicines for commercial purposes <http://www.tga.gov.au/impexp/commercial.htm> have been updated. Please ensure you are using the most up-to-date forms and information.

Influenza vaccine composition

The Australian Influenza Vaccine Committee met on 5 October 2004 and agreed to adopt the September WHO recommendations.

Medicines labelling

The Required Advisory Statements for Medicine Labels <http://www.tga.gov.au/meds/rasml.htm> (RASML) document was established to enable the transfer of all mandatory label advisory statements from the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) and the therapeutic goods regulations to a new document, separate from but linked to TGO 69 General requirements for labels for medicines <http://www.tga.gov.au/docs/html/tgo/tgo69.htm>.

It is mandatory for medicine labels to include any label advisory statements specified in the RASML.

Orphan drugs

Orphan drug products are drugs, vaccines or in vivo diagnostic agents which physicians use to treat, prevent or diagnose rare diseases. The Australian Orphan Drug Program encourages sponsors to market orphan drugs in Australia by reducing costs through waiving fees.

Since the last issue of TGA News, five additions have been made to the list of drugs designated as orphan drugs <http://www.tga.gov.au/docs/html/orphand2.htm>.

Review of Aspirin/Reye's syndrome warning statement

At its meeting on 3 April 2003, the Medicines Evaluation Committee agreed to re-examine the evidence linking aspirin use in children or teenagers with chicken pox, influenza or fever, with Reye's Syndrome, with a view to making further recommendations to the NDPSC about the advisability of adopting the UK warning statement. The purpose of this review is to provide advice on the current evidence linking aspirin use in children or teenagers to Reye's Syndrome and the suitability/necessity of adopting the UK warning statement.

• Review of Aspirin / Reye's syndrome warning statement <http://www.tga.gov.au/npmeds/aspirin_reye.htm>