An Unfavourable benefit-risk profile for Bufexamac: Safety Advisory from TGA

An Unfavourable benefit-risk profile for Bufexamac: Safety Advisory from TGA

An unacceptable benefit-risk ratio identified for a topical medicine- ‘Bufexamac’ which had been in the Over the Counter (OTC) medicine market since decades. In Brief Risks (serous skin ADRs-allergic contact dermatitis leading to hospitalization) Outweighs anticipated benefits (No proven efficacy data, reports of lack of efficacy & Insufficient studies on efficacy) Bufexamac is a cyclo-oxygenase

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