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Revised: 12 June 2019

Safety Information

Medsafe Safety Communications

What are Medsafe safety communications?
Monitoring communications
Alert communications
Medsafe communications issued in the last 12 months
Medsafe communications issued more than 12 months ago
Further information

What are Medsafe safety communications?

These communications are intended to help consumers and healthcare professionals make informed decisions about their use of medicines and medical devices.

Medicines and medical devices provide important benefits for consumers but no product is completely safe. Whilst many risks are identified before the product is used in New Zealand some are identified later.

The known risks associated with medicines in New Zealand are outlined in the consumer medicine information (CMI) and the data sheet. The known risks for medical devices are generally outlined in the product information/user manual. Your healthcare professional can also provide help and assistance on how to use medicines or medical devices. Further information may be found on the product packaging or the company supplying the medicine or medical device may operate a helpline.

There are two types of Medsafe safety communications.

  1. Monitoring communications
  2. Alert communications

Anyone can subscribe to receive Medsafe safety communications.

How do I subscribe to receive Medsafe safety communications?

Monitoring Communications

These communications are intended to provide information to consumers and healthcare professionals about newly identified potential safety concerns.

In some cases, these communications are issued to request further information from users. Safety concerns for medicines for which Medsafe is actively seeking further reports display this symbol:

No actions are generally advised, other than to follow the instructions provided with the medicine or medical device. Consumers should NOT stop using a medicine or medical device following a monitoring communication. Healthcare professionals should not change a patient's treatment because of a monitoring communication.

Not all of these concerns will result in an action. This is because after an investigation, Medsafe may not consider that there is a link between the events and the medicine or medical device. Medsafe may reinvestigate the concern if more information is identified at a later date.

Alert Communications

Alert communications are issued once a review of the safety concern is complete. Alerts contain more information on the safety concern and provide specific advice on actions that may need to be taken by healthcare professionals and consumers.

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

Safety concerns which identify defective medicines or medical devices supplied in the market may result in a recall action. This can include removal of the product from supply or undertaking corrective action. Recent recall actions initiated in New Zealand are published in the Medsafe Online Recalls Database (MORD).

Search the Medsafe Online Recall Database (MORD)

Medsafe Safety Communications Issued in the last 12 months

 

Date Communication Product Type Topic
30 May 2019 Alert Medicine Take care when prescribing and dispensing levodopa-containing products (Madopar, Sinemet, Kinson)
16 May 2019 Monitoring Medicine M² Logo Risk of infections with Prolia (denosumab)  
24 April 2019 Monitoring Medicine Review of the risks of harm and chance of benefit of Cafergot (ergotamine tartrate + caffeine) under section 36 of the Medicines Act 1981
24 April 2019 Alert Medicine Take care when prescribing and dispensing levodopa-containing products (Madopar, Sinemet, Kinson)
Updated:  23 April 2019
18 April 2019
Alert Medicine Consumer Level Recall – Baby Teething Powder & Baby Colic Powder
16 April 2019 Alert Medicine Hydrochlorothiazide: risk of non-melanoma skin cancer
11 April 2019 Monitoring Device Breast Implants and anaplastic large cell lymphoma
22 March 2019 Alert Device Consumer Level Recall – Normal Saline, a component of The Trusts First Aid Kits
6 March 2019 Monitoring Medicine Losartan approved medicines supplied in New Zealand not affected by recalls overseas
4 March 2019 Alert Medicine Use of sodium valproate (Epilim) in girls and women – Change to indications and contraindications
11 February 2019 Alert Medicine Consumer Level Recall – Bronchi-Cough Pills (Qiguanyan Kesou Tanchuanwan)
4 February 2019 Alert Device Recall and Hazard Alert: Medtronic Adapta Dual Chamber Pacemaker
13 December 2018 Monitoring Medicine M² Logo Tramadol and opioid effects in breastfeeding babies
27 November 2018 Alert Medicine Artemisia annua (Sweet wormwood, Sweet Annie, Qing hao) extract marketed as Arthrem: risk of harm to the liver – statement under section 98 of the Medicines Act 1981
26 October 2018 Monitoring Medicine M² Logo Possible risk of lichen planus or lichenoid drug eruption with zoster (shingles) vaccine or influenza vaccine
25 September 2018 Monitoring Medicine M² Logo Update - Dabigatran and gout or gout-like symptoms
5 September 2018 Alert Device The USFDA Warns Against Use of Energy-Based Devices to Perform Vaginal 'Rejuvenation' or Vaginal Cosmetic Procedures: FDA Safety Communication
14 August 2018 Monitoring Medicine M² Logo Isotretinoin and Obsessive Compulsive Disorder (OCD)
13 August 2018 Alert Medicine Codeine – new restrictions on use in children and young adults
6 August 2018 Monitoring Medicine Dolutegravir and the possible risk of neural tube defects when taken early in pregnancy
27 July 2018 Alert Medicine Consumer Level Recall - Melatonin 3mg tablets
9 May 2018 Monitoring Medicine Life-threatening severe allergic reaction (anaphylaxis) to Calocurb dietary supplement

 

Medsafe safety communications issued more than 12 months ago

Further Information

Further information on the development of the Medicines Monitoring scheme M2 Logo and Medsafe's safety monitoring processes can be found in the following links.

What is the Medicines Monitoring scheme M2 Logo?

How does Medsafe monitor medicine safety?

How does Medsafe monitor the safety and quality of medical devices?

Medsafe safety communications were initially developed as a joint project with the Australian Therapeutic Goods Administration (TGA) and called the trans-Tasman Early Warning System. Further information on this project can be found in the following links.

Consumer questions and answers on the early warning system

Healthcare professionals questions and answers on the early warning system

Audit of the first 12 months of the early warning system (PDF, 350KB, 14 pages)

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

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