Medicine safety advisory and product recall
AMA members should be aware that first aid creams containing bufexamac will be removed from the Australian Register of Therapeutic Goods (ARTG) on 18 September 2020 and will no longer be sold in Australia.
This action comes after the Therapeutic Good Administration (TGA) determined that the safety and effectiveness of bufexamac-containing products are unacceptable. Bufexamac is associated with a risk of serious skin reactions (also known as allergic contact dermatitis). The TGA has also determined that there is inadequate evidence that the bufexamac ingredient in these products is effective.
Bufexamac is an over-the-counter non-steroidal anti-inflammatory drug that is used in combination with chlorhexidine and lidocaine (lignocaine) in first aid creams that are applied to the skin.
There have been rare reports of serious skin reactions following use of bufexamac, including generalised acute contact dermatitis, erythema multiforme-like reactions and acute generalised exanthematous pustulosis; when severe, these conditions can lead to scarring, a need for skin grafts and permanent disability.
The following product recalls have also been issued:
1. Various Arrotex bufexamac-containing topical products: all batches
- AUSTR: 230401 - APOHEALTH First Aid Cream tube
- AUSTR: 260392 - BLOOMS THE CHEMIST First Aid Cream tube
- AUSTR: 145050 - CHEMISTS’ OWN Antiseptic Plus Cream tube
2. Various Cipla bufexamac-containing topical products: all batches
- AUSTR: 136256 - PHARMACY CHOICE ANTISEPTIC CREAM tube
- AUSTR: 193197 - PHARMACY ACTION ANTISEPTIC CREAM tube
- AUSTR: 225323 - AMCAL FIRST AID CREAM tube
- AUSTR: 275578 - PRICELINE PHARMACY FIRST AID CREAM tube
- AUSTR: 275579 - PHARMACY HEALTH FIRST AID CREAM tube
- AUSTR: 308966 - TERRYWHITE CHEMMART FIRST AID CREAM tube
More information is available from the TGA here.
Published: 10 Sep 2020