Adverse reaction reporting introduction

The decline in the number of reports of parenter-ally administered gold-induced nephropathy may indicate that the dose of gold salts used per injection is decreased and intervals between injections are being extended to prevent adverse reactions. Furthermore, introduction of methotrexate therapy for rheumatoid arthritis has contributed to decreased reliance on gold salts. 

Three years after introduction of aspirin into therapy, Hirschberg in Poznan, now in Poland, described the first case of a transient, acute angioedema/urticaria, occurring shortly after ingestion of aspirin. Reports of anaphylactic reactions to aspirin soon followed. The other major type of adverse reaction, acute bronchospasm, was described in the second decade of the 20th century. In 1920, Van der Veer reported the first death due to aspirin. The association of aspirin sensitivity, asthma and nasal polyps was first recorded by Widal in 1922. This clinical entity, later named the aspirin triad was popularized in 1968 by Samter and Beers [3], who presented a... 

From currently available data, one adult patient (1/170) challenged with oats was reported to have a severe adverse reaction to oats. Approximately 6% of adults and 9% of children withdrew from clinical trials due to reported adverse effects from the inclusion of oats in their diet. This evidence, along with the indication from some in vitro studies of an immunological response to avenin in the absence of clinical manifestations of celiac disease and the limitations of the database (previously discussed), supports a cautionary approach for the introduction of oats into a gluten-free diet until the prevalence of oats intolerance among people with celiac disease is well established (Dickey, 2008 Garsed and Scott, 2007). 

The reports of major adverse reactions that have been published since the introduction of recombinant hepatitis... 

The withholding of a medication that has achieved clinical acceptance on the basis of clinical observations over many years is as important an action as the introduction of a new compound. In the current actions following upon the drug evaluation reports, millions of clinical observations have been rejected or ignored. This is in remarkable contrast to the situation as it relates to adverse reactions, where a single report, often unsubstantiated, is accepted with finality. 

Adverse reactions to dextran, designated as anaphylactoid or anaphylactic, have been reported since the introduction of dextran into clinical use. During the early... 

Following the first description of allergy to a local anesthetic over 90 years ago, there was initially a steady stream of reports of reactions to the drugs consisting mainly of erythema or edema. With the introduction of the amide local anesthetics, the number of hypersensitivity reactions tapered off significantly, indicating that ester compounds were less well tolerated. Even today, however, reports of adverse reactions to local anesthetics occasionally appear, but the nature of the reactions cannot always be described... 

The ramifications of the thalidomide tragedy were many-fold but the key lesson for the development of pharmacovigilance was that active systems for detecting hazards are needed. Within a few years this had been taken forward with the introduction of voluntary (or spontaneous ) schemes for reporting of suspected adverse drug reactions (ADRs). These have stood the test of time as an alerting mechanism or early warning system and wiU be covered in more detail in Chapter 3. 

Observational studies Long-term octreotide LAR has been studied in 108 patients with midgut neuroendocrine tumors who were followed for 8 years [75 ]. Patients were followed at 6-monthly intervals and seven developed asymptomatic cholelithiasis (average time after the start of treatment 26 months). The rest of the adverse events occurred within 3 months of the start of therapy. Four patients developed severe reactions (an anaphylactic rash, severe abdominal pain, increased diarrhea, and bradycardia) to the test dose of subcutaneous octreotide and were excluded from the study 28 developed steatorrhea, which resolved after the introduction of pancreatic enzyme supplements. Six patients reported... 

Although the initial abstraction reaction has a low activation energy,successive replacement of hydrogen by fluorine will be expected to increase the activation energy both from the concomitant strengthening of C-H bonds and adverse polar effects in the transition state. Of some relevance in this connection are the relative rates of fluorination at different sites reported for gas phase studies of 1-f1uorobutane. These are shown in Fig. 15. It is clear that introduction of fluorine deactivates both a and 3 sites. We may use this data as a basis for discussing the fluorination of polyethylene. 

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