TGA News Issue 41 (July 2003) - Medicines
Note: The information in this issue of TGA News may no longer be current. Please check with the TGA before relying on the information on these web pages.
ADEC 227
Recommendations from the 227th meeting (April 2003) <http://www.tga.gov.au/docs/html/adec/adec0227.htm> of the Australian Drug Evaluation Committee are now available.
Adoption of British Pharmacopoeia 2002
At its February 2003 meeting <http://www.tga.gov.au/docs/html/tgc/tgc21.htm>, the Therapeutic Goods Committee recommended the adoption of the British Pharmacopoeia 2002 for the purposes of the edition of the British Pharmacopoeia defined under the Therapeutic Goods Act 1989. This decision was gazetted in March 2003 <http://www.tga.gov.au/legis/bp2002.htm> and the BP 2002 has been adopted from 1 April 2003.
Adverse drug reactions bulletin
The April and June 2003 issues of the Australian Adverse Drug Reactions Bulletin <http://www.tga.gov.au/adr/aadrb.htm> are now available.
Articles in the June issue <http://www.tga.gov.au/adr/aadrb/aadr0306.htm> include:
- Hyponatraemia with SSRIs
- Pregnancy despite depot medroxyprogesterone
- Hepatic reactions with minocycline
- Implanon and vaginal bleeding
Articles in the April issue <http://www.tga.gov.au/adr/aadrb/aadr0304.htm> include:
- Fluticasone and adrenal crisis
- The glitazones - early experience
- Interstitial nephritis with the proton pump inhibitors
- Interactions with grapefruit juice - amendment
Analgesics review
Ms Trish Worth, Parliamentary Secretary to the Minister for Health and Ageing, released the Review of Non-prescription Analgesics - an update <http://www.tga.gov.au/docs/html/analgupd.htm> on 2 June 2003.
This review was undertaken to address ongoing public health and safety concerns surrounding the labelling and packaging of OTC analgesic medicines.
Australian regulatory guidelines for complementary medicines
The Australian Regulatory Guidelines for Complementary Medicines (ARGCM) <http://www.tga.gov.au/docs/html/argcm.htm> are being developed to:
- provide information to help sponsors of complementary medicines to meet their obligations under therapeutic goods legislation
- help ensure that applications to the TGA relating to complementary medicines uniformly meet all essential regulatory requirements so that applications may be processed successfully within minimum timeframes
- enhance clarity and transparency of processes leading to the registration and listing of complementary medicines in the Australian Register of Therapeutic Goods.
As development of the new guidelines proceeds, draft documents will be published on the TGA website for comment.
Two draft documents are available now for comment. Consultation on these documents closes on 21 July 2003.
CMEC 39
At its 39th meeting (April 2003) <http://www.tga.gov.au/docs/html/cmec/cmecdr39.htm>, the Complementary Medicines Evaluation Committee made recommendations about calcium sodium caseinate and cold-pressed neem (Azadirachta indica) seed oil.
At its 40th meeting (May 2003) <http://www.tga.gov.au/docs/html/cmec/cmecdr40.htm>, CMEC made recommendations about nicotinic acid, isobutylene-isoprene copolymer (butyl rubber) and claims on listable iron-containing products.
CMEC public recommendation summaries <http://www.tga.gov.au/docs/html/cmec/cmecminu.htm> are available on this website.
Compositional guidelines
On 16 April 2003, Trametes versicolor hyphae aqueous extract - powder was gazetted for use in listable therapeutic goods. The gazette notice <http://www.tga.gov.au/legis/tgnlist0301.htm> and the draft compositional guideline <http://www.tga.gov.au/docs/html/compguid/compdr.htm> for Trametes versicolor hyphae aqueous extract - powder are available on this website.
Concerns about the herb Greater celandine
There has been recent media interest following a letter late last year to the medical journal, the Lancet, concerning a possible association between the herb Chelidonium majus (Greater celandine) and liver problems. Greater celandine, or chelidonium, has been traditionally used to treat conditions of the liver and other conditions, and is widely available internationally. The TGA prepared a preliminary safety review on the herb for the most recent meeting of the Complementary Medicines Evaluation Committee (CMEC) <http://www.tga.gov.au/docs/html/cmec/cmec.htm> held on 30 May 2003.
CMEC examined the available evidence on the association between the use of the herb and liver toxicity and noted the fact that, in Germany, where most of the published cases had been reported, the herb remained on the market with an appropriate warning about risks of liver problems. CMEC deferred making a recommendation on the need for any stronger controls over the herb's availability until the TGA has fully completed its review of the safety profile of Chelidonium majus.
In the meantime however, the TGA recommends that anyone who experiences any unexplained symptoms while taking or after using a Chelidonium-containing medicine should seek medical advice. The TGA also advises healthcare practitioners to be on the lookout for signs of liver toxicity which may be linked to the use of Chelidonium-containing medicines. Health professionals are asked to report any suspected adverse reactions thought to be associated with Chelidonium to the Adverse Drug Reactions Unit at the TGA using the postage pre-paid blue card <http://www.tga.gov.au/adr/bluecard.htm> or on 1800 044 114 or using the electronic reporting form <https://www.ebs.tga.gov.au/ebs/ADRS/ADRSRepo.nsf?OpenDatabase>.
European Union guidelines
Guidelines adopted by the TGA are sourced from the Committee for Proprietary Medicinal Products (CPMP) and International Conference on Harmonisation (ICH). Once a particular guideline has been adopted in Australia, it shall be regarded as part of Volume 1 of the Australian Guidelines for the Registration of Drugs (AGRD).
Since April 2003, seven new EU Guidelines have been adopted in Australia, and three guidelines have been replaced. For more information see EU Guidelines - Newly Published <http://www.tga.gov.au/docs/html/euguideh.htm#eugwnp>.
Expert committee on complementary medicines
An expert committee has been set up <http://www.health.gov.au/internet/wcms/Publishing.nsf/Content/health-mediarel-yr2003-tw-tw03018.htm> by the Commonwealth Government to examine the role of complementary medicines in the Australian health care system. Terms of reference and membership of the committee <http://www.health.gov.au/internet/wcms/Publishing.nsf/Content/health-mediarel-yr2003-tw-tw03020.htm> are available.
The committee will focus on issues around the supply of safe, high quality complementary medicines, quality use of and timely access to these medicines, and the maintenance of a responsible and viable complementary medicines industry.
The committee will report back to the Commonwealth Government by mid-August 2003.
Hormone replacement therapy
Australia's Expert Committee on Hormone Replacement Therapy (HRT) has reiterated its advice that HRT should not be used for long-term disease prevention.
The Australian committee continues to have some concerns about HRT and strongly recommends that women discuss their particular circumstances with their doctor as individual factors may affect the risks and benefits of treatment for them.
Ingredients with certain restrictions and conditions
The document Ingredients with certain restrictions and conditions when used in listable medicines has been updated.
OTC guidelines
The TGA has now adopted the Australian Regulatory Guidelines for OTC Medicines (ARGOM) <http://www.tga.gov.au/docs/html/argom.htm>, which replaces the AGRD2 guidelines.
Mr Pio Cesarin (right), Director, Non Prescription Medicines Branch, TGA, hands a copy of the ARGOM to Ms Juliet Seifert (left), Executive Director, Australian Self-Medication Industry Inc.
The working group that contributed to the publication of the ARGOM
Pharmacovigilance
The Australian Pharmacovigilance Guideline <http://www.tga.gov.au/adr/pharmaco.htm>, introduced on 1 July 2002, has been updated with minor amendments. This guideline applies only to prescription medicines regulated by the Drug Safety and Evaluation Branch of the TGA. All sponsors are expected to comply with the requirements set out in this document from 1 January 2003.
The Joint ADRAC-Medicines Australia Guidelines for the Design and Conduct of Company-Sponsored Post-Marketing Surveillance (PMS) Studies <http://www.tga.gov.au/adr/pmsguide.htm>, first developed in 1993, has been updated.
Restriction of topical excipient
The TGA has identified the possibility that C30-38 olefin/isopropyl maleate/MA polymer, an excipient used in topical products, may be responsible for a substantial number of adverse reactions to a listed sunscreen product. Supply of the sunscreen product has ceased and existing stocks have been recalled.
The sponsor of the sunscreen product and the TGA are investigating the reasons for these adverse reactions, but the exact cause may take some time to determine. The material itself had been approved by the TGA following an evaluation of toxicological data (including standard sensitisation / irritation tests). However, C30-38 olefin/isopropyl maleate/MA polymer cannot be ruled out as the cause (either directly or indirectly) of the reported adverse reactions.
Given the concerns surrounding the use of this ingredient, the TGA has removed it from the list of ingredients approved for use in listed medicines until its safety can be assured. In the meantime, applications to list products containing C30-38 olefin/isopropyl maleate/MA polymer (under Section 26A of the Therapeutic Goods Act 1989) will not be accepted.