Drug Safety
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Comparative Study
Potential use of data-mining algorithms for the detection of 'surprise' adverse drug reactions.
Various data mining algorithms (DMAs) that perform disporportionality analysis on spontaneous reporting system (SRS) data are being heavily promoted to improve drug safety surveillance. The incremental value of DMAs is ultimately related to their ability to detect truly unexpected associations that would have escaped traditional surveillance and/or their ability to identify the same associations as traditional methods but with greater scientific efficiency. As to the former potential benefit, in the course of evaluating DMAs, we have observed what we call 'surprise reactions'. These adverse reactions may be discounted in manual review of adverse drug reaction (ADR) lists because they are less clinically dramatic, less characteristic of drug effects in general, less serious than the classical type B hypersensitivity reactions or may have subtle pharmacological explanations. Thus these reactions may only become recognised when post hoc explanations are sought based on more refined pharmacological knowledge of the formulation. The objective of this study was to explore notions of 'unexpectedness' as relates to signal detection and data mining by introducing the concept of 'surprise reactions' and to determine if the latter associations, often first reported in the literature, represent a type of ADR amenable to detection with the assistance of adjunctive statistical calculations on SRS data. ⋯ Identification of surprise reactions may serve as an important niche for DMAs.
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The prescription drugs or drug classes that are most frequently associated with death in the US might be identifiable from death certificate data. ⋯ Deaths due to overdoses are the most prominent cause of drug-related mortality in death certificate data. Certain drugs and drug classes, especially the opioids (e.g. narcotics, methadone), psychoactive drugs (e.g. antidepressants, amfetamines), anticoagulants and antibacterials (which cause or contribute to C. difficile enterocolitis) are associated with large and increasing numbers of deaths and preventive strategies should be considered.
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Clinical Trial
Safety of inhalation of a 50% nitrous oxide/oxygen premix: a prospective survey of 35 828 administrations.
A 50% nitrous oxide/oxygen (N(2)O/O(2)) premix is widely used to alleviate pain or anxiety during brief care procedures in various medical domains. In some countries, recent changes in regulation status for medical gases state that they should be considered as drugs. Consequently, more valuable data gained from exhaustive clinical surveys are needed. This prospective study, conducted in the same conditions imposed for testing a drug, aims to analyse the factors that affect tolerance of the 50% N(2)O/O(2) premix in a wide range of clinical indications. ⋯ This survey confirms the pharmacological safety of the 50% N(2)O/O(2) premix in a wide variety of clinical indications and emphasises the need for rational training of medical personnel in its administration.
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Multicenter Study
Use and safety of anthroposophic medications in chronic disease: a 2-year prospective analysis.
Anthroposophic medications (AMED) are prescribed by physicians in 56 countries worldwide and are used for the treatment of a variety of conditions. However, safety data on long-term use of AMED from large prospective studies are sparse. The objective of this analysis was to determine the frequency of patient-reported and physician-assessed adverse drug reactions (ADRs) to AMED in outpatients using AMED for chronic diseases over a 2-year period. ⋯ In this 2-year prospective study, AMED therapy was generally well tolerated.
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The search for NSAIDs with less gastrointestinal toxicity led to the introduction of the selective cyclo-oxygenase-2 (COX-2) inhibitors. However, following their introduction into the market, concerns have developed regarding their safety, particularly their cardiovascular safety. The purpose of this study was to assess the cardiovascular risk (events included were myocardial infarction, stroke and myocardial infarction-related deaths) associated with long-term (>180 days of exposure) and short-term (