Drug Safety
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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 (
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The frequency of fluoroquinolone-associated anaphylaxis has been estimated to be 1.8-23 per 10 million days of treatment based on spontaneous reports. It is unknown whether there are differences between the reporting rates of anaphylaxis with individual fluoroquinolones. According to pathophysiology, anaphylaxis may be immune mediated (anaphylactic) or not (anaphylactoid). The latter may occur after first-ever intake since no sensitisation phase is necessary. ⋯ Anaphylaxis appears to be associated with the fluoroquinolone class of antibacterials. Observed differences in reporting rates should be further investigated. Fluoroquinolone-associated anaphylaxis may occur after first-ever intake of the agent.