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 - 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	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	Ticagrelor (Brilinta) and a possible association with depression / suicidality added to the Medicine Monitoring scheme	17 October 2016
20 July 2015	Medicine	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	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	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	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	Allopurinol and lichenoid-type skin reactions added to the medicines monitoring scheme	21 November 2014
1 April 2014	Medicine	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	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	Ornidazole and adverse effects on the eye	9 September 2014
1 November 2013	Medicine	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	Champix (varenicline) and a possible interaction with alcohol based on post-marketing reports	28 May 2014