Bufexamac withdrawn from Australian market due to allergic dermatitis
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Bufexamac withdrawn from Australian market due to allergic dermatitis The Therapeutic Goods Administration (TGA) is advising consumers and healthcare professionals that it has withdrawn bufexamac-containing first aid creams from the Australian market because of the risk of a serious skin reaction, allergic contact dermatitis.1 The TGA initially required package warnings about allergic contact dermatitis after investigating the safety of bufexamac in 2011. After additional reports of serious skin reactions requiring hospitalisation, the safety issue was investigated further and the TGA made a decision to cancel the registration of bufexamac-containing products from 18 September 2020. Bufexamac is an over-the-counter non-steroidal anti-inflammatory drug used in combination with chlorhexidine and lidocaine in first aid creams. All 12 bufexamac-containing products entered on the Australian Register of Therapeutic Goods have now been removed from the register because the TGA considers them unacceptable because of the risk of allergic contact dermatitis, and the lack of evidence that bufexamac is effective. The TGA is also reminding advertisers that bufexamac-containing first aid creams are now cancelled therapeutic goods and can no longer be advertised in Australia.2 It will take action against any advertising breaches. 1. Therapeutic Goods Administration. Bufexamac Safety advisory - risk of serious skin reactions Internet Document : 8 Sep 2020. Available from: URL: https:// www.tga.gov.au/alert/bufexamac. 2. Therapeutic Goods Administration. Advertising of first aid creams containing bufexamac to cease in Australia Internet Document : 16 Sep 2020. Available from: URL: https://www.tga.gov.au/media-release/advertising-first-aid-creams-containing-bufexamac-cease-australia. 803505338
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Reactions 3 Oct 2020 No. 1824
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