NSAID cream withdrawn due to skin reactions


14 Sep 2020

The Therapeutic Goods Administration has banned over-the-counter creams containing the NSAID bufexamac after continuing reports of allergic contact dermatitis.

Bufexamac is an ingredient in first aid cream products that often contain ingredients such as chlorhexidine and lidocaine, and which are promoted to treat minor cuts and abrasions; insect bites, stings and itches; and minor burns and sunburn.

The TGA says 12 brands will be removed from the Australian Register of Therapeutic Goods (ARTG) on 18 September 2020 and will no longer be sold in Australia.

The regulator says it made the decision to withdraw Bufexamac products based on advice from the Advisory Committee on Medicines (ACM), which found the products were associated with a risk of serious skin reactions and only weak evidence of efficacy for bufexamac.

A previous safety review of bufexamac in 2011 resulted in package warnings about allergic contact dermatitis. Despite this, the TGA says it has continued to additional reports of serious skin reactions, including some requiring hospitalisation.

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