Safety Information

Revised: 13 August 2018

Early Warning System Alert Communications

This section contains safety alerts for medicines and medical devices.

The safety concerns described here have been investigated by Medsafe. More detailed information about the safety concern and actions that need to be taken by consumers and healthcare professionals are provided.

Alerts are published for serious and significant safety concerns. Alerts provide advice on changes that consumers and healthcare professionals should make to improve the safe use of a medicine or medical device. For some safety concerns, Medsafe may conclude that no actions are required. However, we may still issue an alert to provide information if there is public concern.

Even though an alert has been issued, it does not necessarily mean that a medicine or medical device is considered to be unsafe.

Recent Alert Communications

5 September 2018 Device The USFDA Warns Against Use of Energy-Based Devices to Perform Vaginal 'Rejuvenation' or Vaginal Cosmetic Procedures: FDA Safety Communication
13 August 2018 Medicine Codeine – new restrictions on use in children and young adults
27 July 2018 Medicine Consumer Level Recall - Melatonin 3mg tablets
18 April 2018 Medicine Consumer Level Recall - Apo-Primidone 250mg tablets
15 February 2018 Medicine Arthrem – potential risk of harm to the liver – statement under section 98 of the Medicines Act 1981
9 February 2018 Device UPDATE - Heater-cooler devices used during cardiac surgery: risk of infection with Nontuberculous Mycobacterium species – advice and recommendations
31 January 2018 Device Surgical Mesh Implants - Update
13 December 2017 Device Surgical Mesh Implants - Update
22 September 2017 Medicine Consumer Level Recall - Maxiclear Sinus & Pain Relief and Maxiclear Cold & Flu Relief
21 August 2017 Medicine Gadolinium based contrast agents for MRI and retention of gadolinium in the brain
7 July 2017 Medicine Use of Tramadol During Breastfeeding
24 March 2017 Medicine Andrographis paniculata – potential risk for allergic reactions
22 March 2017 Medicine Consumer Level Recall - EpiPen® (Adrenaline) 300 micrograms (mcg) Auto-Injector
23 December 2016 Device Consumer Level Recall – Pivot, Pivot Hygiene, Pivot Hammock and Tony Pringle clip style sling used for patient hoists

Alert Communications Archive

Further Information

Find out how Medsafe monitors the safety of medicines

Consumer questions and answers on the early warning system

Information about the early warning system

Further information on the criteria used by Medsafe to decide when to publish a monitoring communication (PDF 224KB, 9 pages).

You can subscribe to receive Prescriber Update and Alert Communication emails