Learn More
  • M Hauben, A Bate
  • 2009
Spontaneous reporting is a crucial component of post-marketing drug safety surveillance despite its significant limitations. The size and complexity of some spontaneous reporting system databases represent a challenge for drug safety professionals who traditionally have relied heavily on the scientific and clinical acumen of the prepared mind. Computer(More)
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)
Drug-induced immune thrombocytopenia (DITP) is often suspected in patients with acute thrombocytopenia unexplained by other causes, but documenting that a drug is the cause of thrombocytopenia can be challenging. To provide a resource for diagnosis of DITP and for drug safety surveillance, we analyzed 3 distinct methods for identifying drugs that may cause(More)
The objective of this study was to apply 2 data-mining algorithms to a drug safety database to determine if these methods would have flagged potentially fatal/disabling adverse drug reactions that triggered black box warnings/drug withdrawals in advance of initial identification via "traditional" methods. Relevant drug-event combinations were identified(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 Integrating multiple sources of pharmacovigilance evidence has the potential to advance the science of safety signal detection and evaluation. In this regard, there is a need for more research on how to integrate multiple disparate evidence sources while making the evidence computable from a knowledge representation perspective (i.e., semantic(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)