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Safety Information

Revised: 15 August 2017

Early Warning System Monitoring Communication Archive

This section contains a list of previous monitoring communications for medicines and medical devices.

Medsafe emphasises that patients should NOT stop using any medicine or medical device subject to a monitoring communication. If you have any concerns with a medicine or medical device you are using, please contact your health professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

More information on Monitoring Communications.

Date Medicine/Device Title Update details
7 February 2017 Medicine Update - M² logo Rivaroxaban, dabigatran and apixaban and possible risk of hair loss (alopecia) added to the medicines monitoring scheme  
7 December 2016 Medical Device Update - EasyCheck hCG Urine Pregnancy Test Cassette – Invalid (Negative) and Inconclusive Results  
30 May 2016 Medicine M² logo Rivaroxaban, dabigatran and apixaban and possible risk of hair loss (alopecia) added to the medicines monitoring scheme 7 February 2017
26 May 2016 Medical Device Apex e-chamber spacer device - user issues with valve and round mouthpiece
26 May 2016 Medical Device EasyCheck hCG Urine Pregnancy Test Cassette – Invalid (Negative) and Inconclusive Results
1 March 2016 Medicine M² logo Ticagrelor (Brilinta) and a possible association with depression / suicidality added to the Medicine Monitoring scheme 17 October 2016
20 July 2015 Medicine M² logo Melatonin and Hallucinations added to the medicines monitoring scheme 11 February 2015
22 June 2015 Medicine Influenza vaccine and mild hypersensitivity reactions 3 March 2016
7 April 2015 Medicine M² logo Guaifenesin (guaiphenesin) and possible risk of tinnitus added to the medicines monitoring scheme 9 November 2015
7 November 2014 Medicine Ethics Enalapril 5mg tablets - Difficulty in halving tablets  
20 October 2014 Medicine M² logo Zoledronic acid and possible risk of tendon injury/tendinitis added to the medicines monitoring scheme 22 May 2015
13 October 2014 Medicine Reduced adhesion and efficacy noted by some patients using Mylan Fentanyl Transdermal patches  
11 July 2014 Medicine M² logo Bisphosphonates and possible risk of optic neuritis added to the medicines monitoring scheme 9 February 2015
16 May 2014 Device Cook Petite Vital Port, adherence of tubing to the vessel wall leading to complications in explanting the device  
5 May 2014 Medicine Provive MCT - LCT 1% Emulsion for Injection (10mg/mL) and Provive 1% Emulsion for Injection (10mg/mL) - investigation of infection in Australia 21 July 2014
9 April 2014 Medicine M² logo Allopurinol and lichenoid-type skin reactions added to the medicines monitoring scheme 21 November 2014
1 April 2014 Medicine M² logo Doxazosin and a possible risk of nightmare (paroniria) added to the medicines monitoring scheme 21 November 2014
31 March 2014 Medicine Domperidone (Motilium, Prokinex) and effects on the heart  
27 February 2014 Medicine Effectiveness of emergency contraception may be reduced in women weighing more than 70kg  
3 February 2014 Medicine M² logo Amitriptyline and a possible risk of peripheral coldness (cold hands and/or feet) or Raynaud's phenomenon added to the medicines monitoring scheme 9 September 2014
12 November 2013 Medicine UPDATE: Hydroxyethyl starch solutions (Voluven, Volulyte 6%) associated with increased risk of mortality and renal impairment 16 July 2014
1 November 2013 Medicine M² logo Ornidazole and adverse effects on the eye 9 September 2014
1 November 2013 Medicine M² logo Statins and a possible risk of acute kidney injury (without rhabdomyolysis) 1 August 2014
8 July 2013 Medicine Hydroxyethyl starch solutions (Voluven, Volulyte 6%) associated with increased risk of mortality and renal impairment 12 November 2013
17 June 2013 Medicine M² logo Champix (varenicline) and a possible interaction with alcohol based on post-marketing reports 28 May 2014
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