Published: 20 February 2021
Safety Information
Monitoring communication
Buccaline tablets: review of the benefits and risks under section 36 of the Medicines Act 1981
17 February 2022
On 2 December 2021, the Medicines Adverse Reactions Committee (MARC) discussed the available evidence regarding the effectiveness and safety of Buccaline tablets.
Buccaline (Haemophilus influenzae, pneumococci (I, II, III), Staphylococcus aureus and Streptococcus agalactiae) tablets are a Pharmacist Only medicine indicated for oral antibacterial prophylaxis of complications of colds.
The MARC expressed concern about the lack of evidence of effectiveness and considered that potential harms include hypersensitivity reactions and risks associated with the public delaying or declining other medical treatment. The MARC recommended that a review of Buccaline under section 36 of the Medicines Act 1981 should be conducted.
On 18 January 2022, Medsafe issued a notice under section 36 of the Medicines Act 1981 requesting the sponsor to provide evidence of the safety and efficacy of Buccaline tablets within 60 days. The sponsor is the company responsible for the product in New Zealand.
The report presented to the MARC (PDF 356KB,15 pages) and the meeting minutes are published on the Medsafe website.
Products affected
Additional information
Reporting
Products affected
| Product name | Sponsor |
|---|---|
| Buccaline | Pharmabroker Sales Ltd |
Additional information
Under section 36(1) of the Medicines Act 1981, Medsafe 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 Medsafe 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.
As part of our review, Medsafe welcomes feedback from consumers and healthcare professionals regarding the risks and benefits of Buccaline. Please email your feedback to the Manager, Clinical Risk Management, Medsafe (medsafeadrquery@health.govt.nz). We will consider any feedback received by 12 May 2022.
Reporting
Consumers and healthcare professionals are encouraged to report suspected adverse reactions to medicines to the Centre for Adverse Reactions Monitoring (CARM).
