The Therapeutic Goods Administration (TGA) advised consumers and health professionals 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.
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 (also known as an NSAID), which is used in combination with chlorhexidine and lidocaine (lignocaine) in first aid creams that are applied to the skin. These creams are used to treat minor cuts and abrasions; insect bites, stings and itches; and minor burns and sunburn. There are 12 bufexamac-containing products entered on the ARTG under various brand names.
The TGA investigated the safety of bufexamac in 2011, which resulted in the application of package warnings about allergic contact dermatitis.
The safety issue was reassessed and Advisory committee on medicines (ACM) advice was sought after the TGA received additional reports of serious skin reactions requiring hospitalisation. The result of this investigation is a decision to cancel the registration of all bufexamac-containing products, effective 18 September 2020, as the risk-benefit balance is no longer considered positive.
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