Manfred Hauben

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PURPOSE To compare the results of drug safety data mining with three different algorithms, when adverse events are identified using MedDRA Preferred Terms (PT) vs. High Level Terms (HLT) vs. Standardised MedDRA Queries (SMQ). METHODS For a representative set of 26 drugs, data from the FDA Adverse Event Reporting System (AERS) database from 2001 through(More)
The field of pharmacovigilance (or drug safety surveillance) has evolved significantly over the last few years. Most notably, various statistical methods have been developed and applied to the scan of large-scale adverse event (AE) databases to identify disproportionality in the reporting of specific product-AE combinations against marginal distributions as(More)
While discussions continue about the precise role of data mining in drug safety, there can be little doubt that data mining algorithms have established themselves as a component of the pharmacovigilance " tool-kit ". The drug safety community should facilitate research into the development and testing of novel data mining and statistical algorithms that(More)
INTRODUCTION Pneumothorax is either primary or secondary. Secondary pneumothorax is usually due to trauma, including various non-pharmacologic iatrogenic triggers. Although not normally thought of as an adverse drug event (ADE) secondary pneumothorax is associated with numerous drugs, though it is often difficult to determine whether this association is(More)
BACKGROUND Many illnesses demonstrate seasonal and geographic variations. Pharmacovigilance is unique among public health surveillance systems in terms of the clinical diversity of the events under surveillance. Since many pharmacovigilance signal detection methodologies are geared towards looking for increased frequency of spontaneous adverse drug event(More)
MOTIVATION A principal objective of pharmacovigilance is to detect adverse drug reactions that are unknown or novel in terms of their clinical severity or frequency. One method is through inspection of spontaneous reporting system databases, which consist of millions of reports of patients experiencing adverse effects while taking one or more drugs. For(More)
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