Table 1.

Postmarketing spontaneous reporting data for pancreatitis with MMX® mesalazine

Findings from spontaneous reporting systems
Shire Global Safety Systema [data on file]	• Higher rate of reporting for pancreatitis with MMX mesalazine (21.0 cases per 100,000 person-years of exposure) compared with another marketed controlled-release mesalazine formulation (controlled-release mesalazine; 1.3 cases per 100,000 person-years)
US FDA Adverse Event Reporting System (AERS) database [14]	• Disproportionate reporting of pancreatitis for MMX mesalazine compared with controlled-release mesalazine and delayed-release mesalazine [lower bound of the 95 % confidence interval of the Empirical Bayesian Geometric Mean (EB05) of pancreatitis cases: 5.78 for MMX mesalazine compared with 2.05 for controlled-release mesalazine and 1.92 for delayed-release mesalazine]
Limitations in interpretation [2, 3]
	• Reporting biases due to the difference in time on the US market of the compared drugs (MMX mesalazine launch in 2007, controlled-release mesalazine in 1993, and delayed-release mesalazine in 1992)
	• Underreporting overall and differential underascertainment between drugs
	• Source population (denominator) is unknown, resulting in inability to calculate true incidence rates
	• Incomplete reporting of patient covariates required to adjust for confounding
	• Incomplete supporting data to validate or adjudicate endpoints

FDA Food and Drug Administration

^aFully validated safety database utilized for data entry, storage, and analysis of adverse event information received from sources including but not limited to healthcare practitioners, regulatory authorities, clinical trials, consumers, and the published medical literature. The database allows for aggregate report production and reporting of individual-case safety reports to regulatory authorities