Revised SPCs: Onglyza (saxagliptin hydrochloride) film-coated tablets – all strengths

SPCs warn that if a patient develops blisters/erosions while receiving saxagliptin and bullous pemphigoid is suspected, this medicinal product should be discontinued and referral to a dermatologist should be considered for diagnosis and appropriate treatment.

SPS commentary:

SPCs updated to include post-marketing cases of bullous pemphigoid requiring hospitalisation. In reported cases, patients typically responded to topical or systemic immunosuppressive treatment and discontinuation of the DPP4 inhibitor.


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