Removal of Bufexamac Products

From 18^th September 2020, all products containing bufexamac will be removed from the Australian Register of Therapeutic Goods (ARTG). This action follows an investigation by the Therapeutic Goods Administration (TGA), which concluded that the risk-benefit ratio of bufexamac is not favourable.

Bufexamac is a non-steroidal anti-inflammatory drug (NSAID) and is a well-documented cause of allergic contact dermatitis. Reactions range from localised irritation to widespread polymorphic eruptions, with some patients requiring hospitalisation. The risk of developing a reaction to bufexamac is high, particularly in atopic individuals. Bufexamac has, therefore, been withdrawn in many countries where it was once approved for the treatment of dermatitis. In Australia, bufexamac was only found in combination with a topical anaesthetic and antiseptic for the first aid treatment of minor skin complaints such as abrasions and stings.

In addition to the risk of allergic reactions, the TGA declares that there is insufficient evidence to support the efficacy of bufexamac. While bufexamac will no longer be sold in Australia, a range of alternative first aid creams remain available.