TGA advisories

Advisories explained

Advisories provide important information and recommendations about therapeutic goods.

Even though an advisory has been issued, it does not necessarily mean a product has been found to be unsafe. Users should read the information carefully, and consult a health professional if further information is required.

Advisories may be issued when a therapeutic good:

• has been recalled due to safety concerns
• has been associated with serious or increased adverse reactions
• has required a change to labelling, classification or product information
• may be subject to a supply shortage
• is currently the subject of increased public interest or scrutiny
• has raised concerns internationally

2010 advisories

• Withdrawal of Panvax Junior
  26 August 2010
• Safety advisory: CORE HIV Rapid Test
  26 August 2010
• Access to IV Thiamine
  28 July 2010
• Safety advisory: 1 Body Beautiful
  26 July 2010
• Silicone gel breast implant
  updated 2 July 2010
• Investigation into febrile reactions in young children following 2010 seasonal trivalent influenza vaccination
  status report as at 2 July 2010
• Hydroxycut products
  updated 1 July 2010
• Viagra (sildenafil) 100mg tablets
  21 June 2010
• Gardasil: Human papillomavirus vaccine
  updated 24 June 2010
• Rotavirus vaccines
  18 May 2010
• Western Australian reports of adverse reactions to 2010 seasonal flu vaccine in children
  23 April 2010
• Seasonal flu vaccine and young children
  media release, 23 April 2010
• 'Botanical Slimming Soft Gel' capsules, also known as "Meizitang"
  10 March 2010
• Suspected adverse reactions to Panvax® reported to the TGA 30 September - 30 April 2010
  updated 18 February 2010
• Updated: Advice to consumers regarding Hydroxycut products
  17 February 2010
• Updated: Advice to consumers regarding Hydroxycut products
  5 February 2010
• Reductil (sibutramine)
  22 January 2010
• Indomethacin (INDOCID PDA): anticipated shortage
  13 January 2010

A-Z list of all TGA advisories

0-10

• 1 Body Beautiful (26 July 2010)
  <http://www.tga.gov.au/alerts/medicines/1bodybeautiful.htm>

A

• Analgesics
  • Review of non-prescription analgesics - an update (April 2003)
    <http://www.tga.gov.au/docs/html/analgupd.htm>
  • Review of non-prescription analgesics (February 1998)
    <http://www.tga.gov.au/docs/html/analgesics.htm>
  • Also see:
    • Aspirin
    • Paracetamol
• Arthritis drugs: see Cox-2 inhibitors
• Aspirin
  • Review of Aspirin / Reye's syndrome warning statement (April 2004)
    <http://www.tga.gov.au/npmeds/aspirin_reye.htm>
  • Also see: Analgesics
• Aristolochia
  • Aristolochia alert for practitioners (23 July 2001)
    <http://www.tga.gov.au/docs/html/arialert.htm>
  • Aristolochia fact sheet (24 May 2001)
    <http://www.tga.gov.au/docs/html/aristol.htm>
• Ayurvedic medicines (April 2005)
  <http://www.tga.gov.au/cm/ayurvedic.htm>

B

• Bisphosphonate drugs and osteonecrosis of the jaw (ONJ) (20 December 2007)
  <http://www.tga.gov.au/alerts/medicines/onj.htm>
• Black cohosh: new labelling requirements (29 May 2007)
  <http://www.tga.gov.au/cm/0705blkcohosh.htm>
• 'Botanical Slimming Soft Gel' capsules, also known as "Meizitang" (10 March 2010)
  <http://www.tga.gov.au/alerts/medicines/meizitang.htm>
• BotanicLab (11 September 2002)
  <http://www.tga.gov.au/docs/html/botanicl.htm>
• Breast implants: Silicone gel breast implant (2 July 2010)
  <http://www.tga.gov.au/alerts/devices/silicone.htm>
• Bupropion (Zyban SR) (31 August 2001)
  <http://www.tga.gov.au/docs/html/zyban.htm>

C

• Celebrex (Celecoxib)
  • Potential safety risks with Celebrex (20 December 2004)
    <http://www.tga.gov.au/media/2004/041220_celebrex2.htm>
  • Potential safety risks with Celebrex (18 December 2004)
    <http://www.tga.gov.au/media/2004/041220_celebrex.htm>
  • Celecoxib (Celebrex) not withdrawn from Australian market (9 December 2004)
    <http://www.tga.gov.au/media/2004/041209_celebrex.htm>
• Cerivastatin (withdrawal from sale) (10 August 2001)
  <http://www.tga.gov.au/docs/html/cerivast.htm>
• Child-resistant closure (caps) on some liquid medicines need tightening to ensure safe storage (14 October 2009)
  <http://www.tga.gov.au/alerts/medicines/crc.htm>
• Chuan Xiong Cha Tiao Wan pills: recall (17 April 2009)
  <http://www.tga.gov.au/alerts/medicines/chuan.htm>
• Clexane
  • Further advice on recall of blood-thinning medicine - Clexane (enoxaparin) (3 July 2008)
    <http://www.tga.gov.au/alerts/medicines/clexane.htm>
  • Updated advice on recall of blood-thinning medicine - Clexane (enoxaparin) (17 June 2008)
    <http://www.tga.gov.au/alerts/medicines/clexane3.htm>
  • Recall of blood-thinning medicine - Clexane (enoxaparin) (27 May 2008)
    <http://www.tga.gov.au/alerts/medicines/clexane2.htm>
  • Recall of blood-thinning medicine - Clexane (enoxaparin) (22 April 2008)
    <http://www.tga.gov.au/alerts/medicines/clexane1.htm>
• CORE HIV Rapid Test (safety advisory) (26 August 2010)
  <http://www.tga.gov.au/alerts/devices/core-hiv-rapid.htm>
• Cough, cold & flu medicines
  • Nyal herbal cold and flu products: recall (19 December 2008)
    <http://www.tga.gov.au/alerts/medicines/nyal.htm>
  • TGA announcement regarding the use of cough and cold medicines in children (17 April 2008)
    <http://www.tga.gov.au/media/2008/080409cold.htm>
• Cox-2 inhibitors
  • Regulator takes tough action on arthritis drugs (25 February 2005)
    <http://www.tga.gov.au/media/2005/050225_cox2.htm>
  • Expanded information on Cox-2 inhibitors for doctors and pharmacists (14 February 2005)
    <http://www.tga.gov.au/media/2005/050214-cox2.htm>
  • Also see:
    • Celebrex
    • Lumiracoxib (Prexige)
    • Meloxicam

D

• Diethylstilboestrol (DES)
  • Screening guidelines for women exposed in utero to diethylstilboestrol (DES) (23 April 2008)
    <http://www.tga.gov.au/alerts/medicines/des.htm>
  • Medicine regulator provides further advice for women exposed to diethylstilboestrol (DES) (media statement, 23 April 2008)
    <http://www.tga.gov.au/media/2008/080423des.htm>
  • Doctors urged to keep check on daughters of women who used pregnancy drug three decades ago (media statement, 4 June 2004)
    <http://www.tga.gov.au/media/2004/040609_des.htm>
  • Also see:
    • Section 9.4 of the NHMRC's Screening to Prevent Cervical Cancer: Guidelines for the Management of Asymptomatic Women with Screen Detected Abnormalities provides guidance for the management of women exposed in utero to diethylstilboestrol
      <http://www.nhmrc.gov.au/publications/synopses/wh39syn.htm>
    • The website of the US Centers for Disease Control has a very extensive set of materials about DES for health professionals and consumers.
      <http://www.cdc.gov./dex>
• Dithrasal ointment: recall (6 April 2009)
  <http://www.tga.gov.au/alerts/medicines/dithrasal.htm>

E

• Enoxaparin: see Clexane

F

• Flu vaccines, see:
  • Pandemic (H1N1) Influenza vaccine
  • Seasonal influenza vaccine

G

• Gardasil: Human papillomavirus vaccine (Gardasil) (updated 24 June 2010)
  <http://www.tga.gov.au/alerts/medicines/gardasil.htm>
• Gel packs
  • Updated urgent safety advisory - Hot/cold gel packs (24 September 2008)
    <http://www.tga.gov.au/alerts/devices/gelpacks3.htm>
  • Urgent safety advisory - Hot/cold gel packs (17 September 2008)
    <http://www.tga.gov.au/alerts/devices/gelpacks2.htm>
  • Urgent safety advisory - Hot/cold gel packs (16 September 2008)
    <http://www.tga.gov.au/alerts/devices/gelpacks1.htm>
  • Urgent safety advisory - Thermoskin® hot/cold packs (2 September 2008)
    <http://www.tga.gov.au/alerts/devices/thermoskin.htm>
• Ginkgo Biloba products (2 October 2009)
  <http://www.tga.gov.au/alerts/medicines/gingko.htm>
• Gold Cross Codeine Linctus APF: safety advisory (15 October 2009)
  <http://www.tga.gov.au/alerts/medicines/goldcross.htm>
• Greater celandine (Chelidonium majus): proposed labelling advisory statement (7 August 2003)
  <http://www.tga.gov.au/docs/html/celandine.htm>
• Green lipped mussel & cancer (28 September 1999)
  <http://www.tga.gov.au/docs/html/greenlip.htm>
• Guidant pacemakers: advice to physicians (20 July 2005)
  <http://www.tga.gov.au/recalls/2005/guidant.htm>

H

• H1N1 influenza vaccine, see: Pandemic (H1N1) Influenza vaccine
• Heparin products
  • Consensus Guidelines for Australian Clinicians for the use of anti-coagulants during heparin-based product shortages (Australian Government Department of Health and Ageing, 16 May 2008)
    <http://www.health.gov.au/internet/main/publishing.nsf/Content/heparin-guidelines.htm>
  • Urgent safety advisory on use of Heparin products (updated 7 April 2008 (originally issued 20 March 2008))
    <http://www.tga.gov.au/alerts/medicines/heparin.htm>
  • Heparinised saline 50IU/5ml, packs of 50 ampoules: recall (26 March 2008)
    <http://www.tga.gov.au/recalls/2008/heparin.htm>
  • Also see: Clexane
• Homoeopathic meningococcal vaccines (9 September 2002)
  <http://www.tga.gov.au/docs/html/meninvac.htm>
• Hormone replacement therapy (HRT)
  • ADEC summary statement on HRT (16 April 2004)
    <http://www.tga.gov.au/docs/html/hrtadec3.htm>
  • Update to ADEC statement on use of hormone replacement therapy (17 October 2003)
    <http://www.tga.gov.au/docs/html/hrtadec2.htm>
  • ADEC statement on use of hormone replacement therapy (14 August 2003)
    <http://www.tga.gov.au/docs/html/hrtadec.htm>
  • Advice of Chair of Expert Advisory Group on HRT (media release, 7 August 2003)
    <http://www.tga.gov.au/media/2003/030807hrt.htm>
  • Oestrogen replacement therapy and increased risk of ovarian cancer (7 August 2002)
    <http://www.tga.gov.au/alerts/medicines/ort.htm>
  • Expert Committee reports on HRT (media release, 11 July 2002)
    <http://www.health.gov.au/internet/main/Publishing.nsf/Content/health-mediarel-yr2002-tw-tw02025.htm>
  • Report of Expert Committee convened by the Therapeutic Goods Administration to assess the findings of a report on the safety of the US Women's Health Initiative (combined Hormone Replacement Therapy) trial (11 July 2002)
    <http://www.tga.gov.au/docs/html/hrtreport.htm>
  • Hormone replacement therapy update (media release, 10 July 2002)
    <http://www.health.gov.au/internet/main/Publishing.nsf/Content/health-mediarel-yr2002-tw-tw02023.htm>
• Human papillomavirus vaccine (Gardasil) (updated 24 June 2010)
  <http://www.tga.gov.au/alerts/medicines/gardasil.htm>
• Hydroxycut products
  • Updated: Advice to consumers regarding Hydroxycut products (1 July 2010)
    <http://www.tga.gov.au/alerts/medicines/hydroxycut.htm>
  • Updated: Advice to consumers regarding Hydroxycut products (17 February 2010)
    <http://www.tga.gov.au/alerts/medicines/hydroxycut-100217.htm>
  • Updated: Advice to consumers regarding Hydroxycut products (5 February 2010)
    <http://www.tga.gov.au/alerts/medicines/hydroxycut-100205.htm>
  • Advice to consumers regarding Hydroxycut products (8 May 2009)
    <http://www.tga.gov.au/alerts/medicines/hydroxycut-090508.htm>
• Hypericum perforatum: see St Johns' Wort

I

• Indomethacin (INDOCID PDA): anticipated shortage (13 January 2010)
  <http://www.tga.gov.au/alerts/medicines/indocid.htm>
• Influenza vaccines, see:
  • Pandemic (H1N1) Influenza vaccine
  • Seasonal influenza vaccine
• IV Thiamine - access to (28 July 2010)
  <http://www.tga.gov.au/alerts/medicines/ivthiamine.htm>

K

• Kava
  • Kava fact sheet (April 2005)
    <http://www.tga.gov.au/cm/kavafs0504.htm>
  • Information for sponsors: safety of kava-containing medicines (August 2002)
    <http://www.tga.gov.au/docs/html/kavaspon.htm>
  • TGA recalls over the counter medicines containing kava (media release, 15 August 2002)
    <http://www.health.gov.au/internet/main/Publishing.nsf/Content/health-mediarel-yr2002-tw-tw02026.htm>
  • Consumer warning on kava-containing medicines (media release, 17 March 2002)
    <http://www.health.gov.au/internet/main/Publishing.nsf/Content/health-mediarel-yr2002-tw-tw02005.htm>
  • Consumer advice on kava (26 February 2002)
    <http://www.tga.gov.au/docs/html/kavaci.htm>
  • Kava practitioner alert (26 February 2002)
    <http://www.tga.gov.au/docs/html/kavapa.htm>

L

• Lida Daidaihua Slimming Capsules (19 October 2007)
  <http://www.tga.gov.au/alerts/lida.htm>
• Lumiracoxib (Prexige)
  • Urgent advice regarding management of patients taking lumiracoxib (Prexige) (advice for health professionals, 13 August 2007)
    <http://www.tga.gov.au/alerts/prexige.htm>
  • Medicines Regulator cancels registration of anti inflammatory drug, Lumiracoxib (media statement, 11 August 2007)
    <http://www.tga.gov.au/media/2007/080922-lumiracoxib.htm>
  • Urgent medicine recall - Lumiracoxib (Prexige) (recall notice, 10 August 2007)
    <http://www.tga.gov.au/recalls/2007/lumiracoxib.htm>

M

• Meizitang: 'Botanical Slimming Soft Gel' capsules, also known as "Meizitang" (10 March 2010)
  <http://www.tga.gov.au/alerts/medicines/meizitang.htm>
• Meloxicam: Status of action on products containing meloxicam (15 April 2005)
  <http://www.tga.gov.au/media/2005/050415-meloxicam.htm>
• Methodone: Physeptone (methadone): shortage (8 January 2001)
  <http://www.tga.gov.au/alerts/medicines/methadone.htm>

N

• Nyal herbal cold and flu products: recall (19 December 2008)
  <http://www.tga.gov.au/alerts/medicines/nyal.htm>

O

• Oestrogen replacement therapy and increased risk of ovarian cancer (7 August 2002)
  <http://www.tga.gov.au/alerts/medicines/ort.htm>

P

• Pandemic (H1N1) Influenza vaccine
  • Panvax Junior - withdrawal (26 August 2010)
    <http://www.tga.gov.au/alerts/medicines/panvax-jr-withdrawal.htm>
  • Suspected adverse reactions to Panvax® reported to the TGA 30 September - 30 April 2010 (updated 18 February 2010)
    <http://www.tga.gov.au/alerts/medicines/h1n1vaccine.htm>
  • TGA approves Pandemic (H1N1) 2009 influenza vaccine for use in children aged from 6 months of age (3 December 2009)
    <http://www.tga.gov.au/alerts/medicines/h1n1vaccine2.htm>
  • TGA approves vaccine against Pandemic (H1N1) 2009 influenza (18 September 2009)
    <http://www.tga.gov.au/alerts/medicines/h1n1vaccine.htm>
• Paracetamol
  • Practitioner fact sheet – paracetamol (12 June 2003)
    <http://www.tga.gov.au/docs/html/paracetpr.htm>
  • Information for consumers – paracetamol (12 June 2003)
    <http://www.tga.gov.au/docs/html/paracetco.htm>
  • Guidelines released for safe use of paracetamol (media release, 2 June 2003)
    <http://www.health.gov.au/internet/main/publishing.nsf/Content/health-mediarel-yr2003-tw-tw03025.htm>
  • Also see: Analgesics
• Paroxetine:
  • Advice for women taking paroxetine intending to become pregnant or in early preganancy (7 September 2005)
    <http://www.tga.gov.au/alerts/paroxetine.htm>
  • Also see: SSRI antidepressants
• Peripherally inserted central catheters (PICC lines)
  • Serious adverse events with the use of Peripherally Inserted Central Catheters (PICC lines) (13 November 2008)
    <http://www.tga.gov.au/alerts/devices/picc3.htm>
  • Serious adverse events with the use of Peripherally Inserted Central Catheters (PICC lines) (24 October 2008)
    <http://www.tga.gov.au/alerts/devices/picc2.htm>
  • Serious adverse events with the use of Peripherally Inserted Central Catheters (PICC lines) (20 October 2008)
    <http://www.tga.gov.au/alerts/devices/picc1.htm>
  • Serious adverse events identified in Queensland with the use of Peripherally Inserted Central Catheters (PICC lines) (10 October 2008)
    <http://www.tga.gov.au/alerts/devices/picc.htm>
• Phenylpropanolamine (7 March 2006)
  <http://www.tga.gov.au/docs/html/ppa.htm>
• Physeptone (methadone): shortage (8 January 2001)
  <http://www.tga.gov.au/alerts/medicines/methadone.htm>
• Polio vaccine & SV40 contamination (14 December 2004)
  <http://www.tga.gov.au/alerts/sv40.htm>
• Prexige: see Lumiracoxib (Prexige)

R

• Reductil (sibutramine) (22 January 2010)
  <http://www.tga.gov.au/alerts/medicines/reductil.htm>
• Rotavirus vaccines (18 May 2010)
  <http://www.tga.gov.au/alerts/medicines/rotarix.htm>

S

• Seasonal flu vaccine
  • Investigation into febrile reactions in young children following 2010 seasonal trivalent influenza vaccination (status report as at 2 July 2010)
    <http://www.tga.gov.au/medicines/fluvaccine-report100702.htm>
  • Seasonal flu vaccine and young children (media release, 23 April 2010)
  • Western Australian reports of adverse reactions to 2010 seasonal flu vaccine in children (23 April 2010)
    <http://www.tga.gov.au/alerts/medicines/fluvaccine.htm>
• Sibutramine: Reductil (sibutramine) (22 January 2010)
  <http://www.tga.gov.au/alerts/medicines/reductil.htm>
• Sildenafil: Viagra (sildenafil) 100mg tablets: counterfeit (21 June 2010)
  <http://www.tga.gov.au/alerts/medicines/viagra.htm>
• Silicone gel breast implant (2 July 2010)
  <http://www.tga.gov.au/alerts/devices/silicone.htm>
• SSRI antidepressants
  • Release of the Report of the Psychiatric Drug Safety Expert Advisory Panel (24 December 2009)
    <http://www.tga.gov.au/alerts/medicines/pdseap-report2009.htm>
  • Advice for women taking paroxetine intending to become pregnant or in early preganancy (7 September 2005)
    <http://www.tga.gov.au/alerts/paroxetine.htm>
  • General information concerning use of SSRI antidepressants in pregnant women (7 September 2005)
    <http://www.tga.gov.au/alerts/ssri-gen.htm>
  • Information for health professionals concerning use of SSRI antidepressants in pregnant women (7 September 2005)
    <http://www.tga.gov.au/alerts/ssri-hp.htm>
  • Actions by the Therapeutic Goods Administration concerning use of antidepressants in children and adolescents (15 October 2004)
    <http://www.tga.gov.au/adr/ssri_tga.htm>
  • Use of SSRI antidepressants in children and adolescents (ADRAC, 15 October 2004)
    <http://www.tga.gov.au/adr/adrac_ssri.htm>
  • Use of SSRI antidepressants in children and adolescents (ADRAC, 17 June 2004)
    <http://www.tga.gov.au/adr/adrac_ssri_040617.htm>
  • Use of SSRI antidepressants in children and adolescents (ADRAC, 11 March 2004)
    <http://www.tga.gov.au/adr/adrac_ssri_040311.htm>
• St John's Wort
  • TGA alert to doctors and pharmacists and complementary health practitioners - Important interactions between St John's Wort (Hypericum perforatum) preparations and prescription medicines (15 March 2001)
    <http://www.tga.gov.au/docs/html/alert.htm>
  • Information for consumers taking St John's Wort (5 September 2000)
    <http://www.tga.gov.au/docs/html/sjwinfo.htm>
  • St John's Wort - Information sheet for health care professionals (13 March 2000)
    <http://www.tga.gov.au/docs/html/info.htm>
• Stilnox: Zolpidem (Stilnox) (21 February 2008)
  <http://www.tga.gov.au/alerts/stilnox2.htm>
• Sunscreens
  • TGA fact sheet: Sunscreens (August 2009)
    <http://www.tga.gov.au/npmeds/sunscreen-zotd.htm>
  • Potential oestrogenicity of sunscreens (24 August 2001)
    <http://www.tga.gov.au/medicines/oestrogenicity.htm>

T

• Trasylol (aprotinin) injection (9 November 2007)
  <http://www.tga.gov.au/alerts/trasylol.htm>

V

• Viagra (sildenafil) 100mg tablets: counterfeit (21 June 2010)
  <http://www.tga.gov.au/alerts/medicines/viagra.htm>
• Vytorin and cancer risk (4 September 2008)
  <http://www.tga.gov.au/alerts/medicines/vytorin.htm>

Z

• Zirconia femoral head hip prostheses: spontaneous disintegration (23 August 2001)
  <http://www.tga.gov.au/alerts/devices/zirconia.htm>
• Zolpidem (Stilnox) (21 February 2008)
  <http://www.tga.gov.au/alerts/stilnox2.htm>
• Zyban: Bupropion (Zyban SR) (31 August 2001)
  <http://www.tga.gov.au/docs/html/zyban.htm>

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