Published: 15 November 2021
Safety Information
Alert communication
Consent to distribute medicines containing bufexamac was revoked on 9 November 2021
The consent for topical products containing bufexamac will be revoked on 9 November 2021. The risks of serious skin reactions from bufexamac outweigh any possible benefits when used for the treatment of insect bites, stings and itches, and minor burns and sunburn.
Advice for consumers and caregivers
Information for healthcare professionals
Products affected
Additional information
Useful links
Advice for consumers and caregivers
- Bufexamac can cause serious skin reactions
- Creams containing bufexamac are no longer available for sale
in New Zealand.
All products containing this ingredient that were sold in New Zealand in the past will now be past their expiry date. - If you still have any products containing bufexamac, please dispose of them by returning them to your pharmacy.
Information for healthcare professionals
- Bufexamac is a non-steroidal anti-inflammatory medicine formulated for topical application.
- Serious skin reactions have been reported overseas following the use of topical bufexamac-containing products.
- The risk of serious skin reactions outweighs the benefits of using bufexamac-containing products. The Medicines Adverse Reactions Committee (MARC) recommended revocation of the consent for these products at the 186th MARC meeting on 10 June 2021.
- All products containing bufexamac that were sold in New Zealand in the past will now have passed their expiry date and should be returned to pharmacies for disposal.
- Please discuss alternative treatment options with any patients who may still wish to use a bufexamac-containing product for minor skin conditions such as insect bites, stings and itches, and minor burns and sunburn.
Products affected
There are currently no approved products containing bufexamac available for sale in New Zealand.
Previously available products containing bufexamac that were sold in New Zealand include:
| Product name | Sponsor |
|---|---|
| Antiseptic Soothing Cream | Multichem NZ Limited |
| Paraderm Plus Topical Cream | Pfizer New Zealand Limited |
Additional information
Medsafe issued a Monitoring Communication on 10 December 2020 (see Useful links) advising that serious skin reactions had been reported overseas following the use of bufexamac-containing products.
Medsafe issued a notice under section 36(1) of the Medicines Act 1981 for Antiseptic Soothing Cream in December 2020. Medsafe subsequently referred bufexamac to the Medicines Adverse Reactions Committee (MARC) under section 36(2) of the Medicines Act 1981.
The MARC reviewed the safety of bufexamac-containing products at the 186th meeting on 10 June 2021. The Committee considered that the risk of serious skin reactions associated with bufexamac outweighed any possible benefits of the medicine. The Committee therefore recommended that the sale and supply of medicines containing bufexamac be prohibited.
Useful links
- Monitoring Communication: Antiseptic Soothing Cream - review of the benefits and risks requested under section 36 of the Medicines Act 1981.
- Minutes of the 186th MARC meeting: 3.1.1 Consideration of bufexamac-containing medicines under section 36 of the Medicines Act 1981
- MARC Report: Consideration of bufexamac-containing medicines under section 36 of the Medicines Act 1981
- Therapeutic Goods Administration (Australia) safety advisory. Bufexamac – risk of serious skin reactions
- Report suspected adverse reactions to medicines to the Centre for Adverse Reactions Monitoring (CARM).
