Published: 12 August 2021
Updated 15 February 2022
Safety Information
Monitoring
Dihydrocodeine: review of risks and benefits
Update to original communication
15 February 2022
On 2 December 2021, Medsafe presented a risk-benefit review of dihydrocodeine (DHC) and referred two DHC products to the Medicines Adverse Reactions Committee under section 36 of the Medicines Act 1981. The Committee was asked to advise whether the benefit-risk balance is favourable for the use of DHC for pain treatment and if any regulatory action is required to improve the balance of benefits and risks.
The Committee agreed that there was insufficient evidence to recommend revoking consent of the approved DHC products in New Zealand. However, they recommended imposing two conditions on the use of the two dihydrocodeine products.
The first condition was to align the indications in the New Zealand data sheets with the Australian class statements for modified release opioid products:
[Product] is indicated for the management of severe pain where:
- other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and
- the pain is opioid-responsive, and
- requires daily, continuous, long term treatment.
[Product] is not indicated for use in chronic non-cancer pain other than in exceptional circumstances.
[Product] is not indicated as an as-needed (PRN) analgesia.
The second condition was for the sponsors to provide consumer medicine information leaflets for their products.
Medsafe has notified the sponsors of these conditions.
The report presented to the MARC and the Committee meeting minutes are published on the Medsafe website.
- Minutes of the 188th Medicines Adverse Reactions Committee meeting, 2 December 2021
- Report presented to the Medicines Adverse Reactions Committee
Original communication
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.
- Minutes of the 186th Medicines Adverse Reactions Committee meeting, June 2021
- Report presented to the Medicines Adverse Reactions Committee
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).
