Published: 12 August 2021

Safety Information

Monitoring

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, please contact your healthcare professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

Dihydrocodeine: review of risks and benefits

Published: 12 August 2021

Medsafe is requesting feedback from consumers and healthcare professionals regarding the risks and benefits of dihydrocodeine. Feedback must be provided by 24 September to be considered in the Medsafe review.

Dihydrocodeine is an opioid medicine used to relieve pain following surgery and for pain associated with cancer. It is also used for opioid-responsive, chronic severe pain where other pain medicines have not been successful.

Products affected
Additional information
Regulator actions
Reporting

Products affected

Product name Sponsor
DHC Continus Mundipharma New Zealand Ltd
Dihydrocodeine Controlled Release Actavis (not available) Teva Pharma (New Zealand)

Additional information

Medsafe and the Medicines Adverse Reactions Committee (MARC) have been reviewing the risks of misuse, abuse and dependence with opioids in New Zealand. At their meeting in June 2021, the MARC recommended that a risk benefit review of dihydrocodeine should be performed.

The report presented to the MARC and the Committee meeting minutes are published on the Medsafe website.

Advice on how to take dihydrocodeine and known side effects can be found in the consumer medicine information (CMI) and data sheet.

Search for consumer medicine information and data sheets

Regulator actions

As part of our review, Medsafe welcomes feedback from consumers and healthcare professionals regarding the risks and benefits of dihydrocodeine. Please email your feedback to the Manager, Clinical Risk Management, Medsafe (medsafeadrquery@health.govt.nz). We will consider any feedback received by 24 September 2021.

On 12 July 2021, Medsafe issued a section 36(1) of the Medicines Act 1981 (the Act) notice to the sponsors of dihydrocodeine products. Under this section of the Act, the Director-General of Health may request the sponsor to provide evidence that a product is safe and effective for the therapeutic purpose for which it is sold. If the sponsor is unable to satisfy the Director-General that the product is safe and effective for its therapeutic purpose, conditions on the use of the medicine may be imposed or the consent for distribution of the product may be revoked.

Reporting

Consumers and healthcare professionals are encouraged to report suspected adverse reactions to medicines to the Centre for Adverse Reactions Monitoring (CARM).

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