P492 Cumulative safety signal review confirmed the established safety profile of Asacol™† (mesalazine)

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Background: Asacol™ (mesalazine) is indicated for induction and maintenance of remission of Ulcerative colitis and maintenance of remission of Crohn's ileo-colitis (indication may vary upon formulation and country). Signal detection (for early identification of hazards associated with the drug) is part of routine safety activities within the pharmaceutical industry and can be performed either in a quantitative or qualitative manner.

Methods: A cumulative signal review was conducted querying the pharmacovigilance database aided by standardised MedDRA terms. Data from single cases arising from all sources of the concerned product were analysed applying GVP criteria (including strength of the association, consistency of data, exposure response relationship and biological plausibility). Potential signals were assessed for causal relationship with the use of Asacol™. Identified signals were validated/rejected by a steering committee and either closed without further action, included in the product's label, or kept under close monitoring.

Results: Overall 19 potential signals were detected from 1500 adverse events reports and considered relevant for further investigation.

Of these, 8 (Anaemia, tinnitus, hypoaesthesia, acute hepatic failure, atrial septal defect, angioedema, organising pneumonia and bronchiectasis) were closed without further action; 8 (DRESS syndrome, PRES, severe cutaneous adverse reactions, sinus bradycardia, vasculitis, and benign intracranial hypertension) are being closely monitored; 3 (pleurisy, CRP-increased and exacerbation of symptoms of underlying disease) were included in the reference safety information.

A literature search revealed several reports of pleural disease associated to mesalazine therapy. Limited information is available on CRP-increased, however some studies suggest that CRP levels are significantly higher in patients with active disease. There is evidence that symptoms of intolerance to mesalazine can manifest itself as exacerbation of disease. It is therefore difficult to draw the line between exacerbation of underlying disease due to natural course of disease and exacerbation due to Asacol™.

Conclusions: With more than 30 years of experience and more than 2.9 million patient years of post-marketing exposure, the safety profile of Asacol™ is well established. The three new signals' assessment revealed no significant impact on the product's safety profile.

†Tillotts Pharma AG's Asacol™ is registered in 42 countries worldwide. Tillotts Pharma AG doesn't own rights to Asacol in CH, US, GB, CA, IT, BE, NL or LU.

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