Adverse drug reactions Toxicity

The nurse monitors vital signs every 4 hours or as ordered. Any adverse drug reactions or signs of toxicity are reported to the primary health care provider immediately. 

The nurse must also closely observe die patient for odier adverse drug reactions, such as anorexia, nausea, vomiting, and diarrhea. Some adverse drug reactions are also signs of digitalis toxicity, which can be serious. The nurse should carefully consider any patient complaint or comment, record it on die patient s chart, and bring it to die attention of the primary care provider. 

Diarrhea, cramps, nausea, and vomiting are die more common adverse drug reactions. A reduction in die dose may reduce or eliminate these problems. Prolonged use of tiiese drugs may result in hepatotoxicity (toxic to die liver). 

The extensive clinical experience with these drugs in epilepsy shows they are better tolerated and less toxic than lithium (Bowden and Muller-Oerlinghausen, 2000 Rang et ah, 2003). Since the dose regimens for epilepsy and affective disorders are similar, it would be expected that the levels of adverse drug reactions would also be similar. With... 

Meanwhile, these chemicals—like chemical agents encountered at work or in hobbies or as pollutants in air, water, soil, or food—can also cause harm. Sometimes the known mechanisms of action permit us to predict the nature of toxicity to be expected. A meta-analysis of prospective studies from U.S. hospitals indicates that 6.7% of in-patients have serious adverse drug reactions 0.3% have fatal reactions (Lazarou et al., 1998). In fact, estimates of 40,000 to 100,000 deaths per year attributed to errors in medical care, primarily due to adverse reactions to pharmaceuticals, make this phenomenon a major cause of death in the United States (Meyer, 2000). A tremendous... 

Approximately 10% of new chemical entities (NCEs) show serious adverse drug reactions (ADRs) after market launch. Such events usually result in new black box warnings by the US Food and Drug Administration (FDA), label change or market withdrawal. The most common causes for these actions are hepatic toxicity, hematologic toxicity and cardiovascular toxicity [2], Reasons for such ADRs, which are identified only after NCEs are launched on the market, include the narrow spectrum of clinical disorders and participating patient profiles in clinical studies as well as the fact that serious ADRs are often rare and that the number of patient exposures required to identify such occurrences sometimes may range over a few millions [3],... 

The in vivo data sets can be classified as compound details, adverse drug reaction data (ADR), pharmacokinetic data and animal toxicity data. 

In contrast to these concentrations many clinically-used drugs, which are non-inducers are effective at doses up to two orders of magnitude lower. The need for high doses has other undesirable complications. As outlined above dose size is important in toxicity and enzyme inducers show a high level of adverse drug reactions affecting such organs and tissues as the liver, blood and skin (Table 8.4). 

Holt D., D. Harvey, and R. Hurley (1993). Chloramphenicol toxicity. Adverse Drug Reactions and Toxicological Reviews 12 83-95. 

Even for established excipients, regulators will look carefully at their presence in new drug formulations because they are not necessarily inert materials and some have well-established activity and/or toxicity. Clinically relevant adverse reactions are known for well-known excipients and the subject is covered elsewhere in the published literature (2,20,75-81). Findings tend to be uncommon compared to the overall prevalence of adverse drug reactions and often involve hypersensitivity reactions that are not likely to be predicted by conventional toxicity studies. 

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