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Bufexamac

Safety advisory - risk of serious skin reactions

8 September 2020

Consumers and health professionals are advised 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.

The Therapeutic Goods Administration (TGA) has determined that, based on our assessment and independent advice from the Advisory Committee on Medicines (ACM), 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 (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 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.

Information for consumers

If you have any unused topical cream that contains bufexamac, be aware that it is associated with a risk of serious skin reactions. The TGA has also determined that there is inadequate evidence that the bufexamanc ingredient in these products is effective.

Topical creams containing bufexamac will be cancelled from the ARTG from 18 September 2020 and therefore will no longer be sold in Australia.

If you have any questions or concerns about this issue, talk to your health professional.

Information for health professionals

Please be aware of the above issue and advise patients accordingly if they seek advice.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.