Australia's TGA Pulls Bufexamac, Citing Serious Skin Reactions

Australia’s Therapeutic Goods Administration (TGA) has announced that it is revoking drugmaker approvals of 12 first-aid cream products that contain the anti-inflammatory drug bufexamac on Sept. 18 due to the risk of serious skin reactions and will not allow them to be sold in Australia.

Bufexamac is used in combination with chlorhexidine and lidocaine (lignocaine) in first-aid creams for minor cuts, stings and minor burns. There are currently 12 products containing bufexamac registered in Australia.

In addition to the risk of allergic contact dermatitis, the agency said it did not find adequate evidence that the ingredient is effective. The TGA has been investigating the safety of bufexamac since 2011.